Prospective Observational Study of Site-Specific Incident and Prevalent Cases of Cancer in People Living With HIV/AIDS- in Latin America
Conditions: HIV Infection, Human Immunodeficiency Virus 1 Positive, Malignant Neoplasm, Recurrent Malignant Neoplasm
Sponsor: AIDS Malignancy Consortium

AMC S008 (Version 3.0) 22JAN2021 
 
i 
NCI Version Date 22JAN2021 
SUMMARY OF CHANGES 
Prospective Observational Study of the Frequency of Site-Specific New and Existing Cases 
of Cancer in People Living with HIV/AIDS- in Latin America 
Version 3.0 
 
NCI Protocol #: AMC-S008 
Local Protocol #: AMC-S008 
 
NCI Version Date: 22JAN2021 
Protocol Date: 22JAN2021 
 
I. 
Scientific and Substantive Changes: 
# 
Section 
Comments 
1. 
What is the 
purpose? 
The number of participants that will take part in this study has been revised 
from 200 to 400 for consistency with the protocol.  
II. 
Administrative and Editorial Changes: 
# 
Section 
Description of Changes 
1. 
Global 
The version number and date were updated from version 2 dated 
02OCT2019 to version 3 dated 22JAN2021. 
 
What will 
happen if I 
decide to 
partake in 
this study? 
Follow up period was extended and may be completed 1-3 months after 
enrollment, for consistency with the protocol.  
 
 
 

Protocol Version Date: 22JAN2021 
 
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^Notes for Local Investigators: 
 
• The goal of the informed consent process is to provide potential study participants with clear, 
accurate, unbiased, and sufficient information so that they can make informed choices about 
participating in research. The ICD is one part of the consent process. It provides a summary of 
the study, describes foreseeable risks, discusses the individual’s rights as a study participant, 
and documents their willingness to participate. The ICD, however, is only one piece of an 
ongoing exchange of information between the investigator and study participant.  
 
• Sections that will require edits from local site investigators are highlighted in yellow. These 
instructions and formatting should remain in the consent form for the local sites. Local sites 
should remove them from the consent form for patients. 
 
 

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AMC-S008 (Version 3.0) 22JAN2021 
RESEARCH STUDY INFORMED CONSENT DOCUMENT 
Study Title for Participants: Counting the number of people living with HIV/AIDS and with 
new and existing cancers at 4 clinics in Latin America 
Official Study Title for Internet Search on http://www.ClinicalTrials.gov: AMC-S008: 
Prospective Observational Study of the Frequency of Site-Specific New and Existing Cases of 
Cancer in People Living with HIV/AIDS- in Latin America 
OVERVIEW AND KEY INFORMATION  
What am I being asked to do? 
We are asking you to take part in a research study. We do research studies to try to answer 
questions about how to prevent, diagnose, and treat diseases like cancer. 
We are asking you to take part in this research study because you have HIV/AIDS and cancer. We 
want to understand what types of cancer are treated at this center, and how your cancer has been 
or will be treated. 
Taking part in this study is your choice.  
You can choose to take part, or you can choose not to take part in this study. You also can change 
your mind at any time. Whatever choice you make, you will not lose access to your medical care 
or give up any legal rights or benefits. 
This document has important information to help you make your choice. Take time to read it. Talk 
to your doctor, family, or friends about the risks and benefits of taking part in the study. It’s 
important that you have as much information as you need and that all your questions are answered. 
See the “Where can I get more information?” section for resources for more clinical trials and 
general cancer information. 
Why is this study being done? 
This study is being done to answer the following question:  
How many people have HIV/AIDS and cancer at four centers in Latin American and what has 
their care and treatment been? 
We are doing this study because we want to find out what the approach for your cancer and to plan 
future research studies for cancers in people living with HIV/AIDS at these centers in Latin 
America. 
WHAT IS THE USUAL APPROACH? 
This study only involves collecting information about you and your cancer treatment. Taking part 
in this study will not change the way you are given care or treatment for your HIV/AIDS or your 
cancer. 
WHAT ARE MY CHOICES IF I DECIDE NOT TO TAKE PART IN THIS STUDY? 
• You may choose to take part in a different research study if one is available. 
• You may choose to continue your care without any research. 
WHAT WILL HAPPEN IF I DECIDE TO TAKE PART IN THIS STUDY? 
If you decide to take part in this study the doctor will collect information about your current HIV 

Protocol Version Date: 22JAN2021 
 
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AMC-S008 (Version 3.0) 22JAN2021 
status and treatment, your cancer status and treatment and your current health status at your next 
visit. 
If further treatment for your cancer is planned, in about one to three (1-3) month(s) your doctor 
will follow-up and collect the same information again. This may happen at another visit, over the 
phone, or through your medical records. 
WHAT ARE THE RISKS AND BENEFITS OF TAKING PART IN THIS STUDY? 
There are both risks and benefits to taking part in this study. It is important for you to think 
carefully about these as you make your decision.  
Risks 
We want to make sure you know about a few key risks right now. We give you more information 
in the “What risks can I expect from taking part in this study?” section. 
If you choose to take part in this there may be a risk to your privacy. The researchers will make 
every effort to protect it and your data will be secured.  
Benefits 
This study will not help you. This study will help the study doctors learn things that will help 
people in the future.  
IF I DECIDE TO TAKE PART IN THIS STUDY, CAN I STOP LATER? 
Yes, you can decide to stop taking part in the study at any time.  
If you decide to stop, let your study doctor know as soon as possible.  
Your study doctor will tell you about new information or changes in the study that may affect your 
health or your willingness to continue in the study. 
ARE THERE OTHER REASONS WHY I MIGHT STOP BEING IN THE STUDY? 
Yes. The study doctor may take you off the study if: 
• New information becomes available and the study is no longer in your best interest. 
• You do not follow the study rules. 
• The study is stopped by the Institutional Review Board (IRB), Food and Drug Administration 
(FDA), or sponsor (National Cancer Institute).  
It is important that you understand the information in the informed consent before making 
your decision. Please read, or have someone read to you, the rest of this document. If there is 
anything you don’t understand, be sure to ask your study doctor or nurse. 
WHAT IS THE PURPOSE OF THIS STUDY? 
The purpose of this study is to count how many people at your cancer center have HIV/AIDS and 
cancer and to understand how people are being treated and cared for. We expect to have up to 400 
people take part in the trial. This will help researchers understand what new studies may be helpful 
for your area in the future.  
WHAT ARE THE STUDY GROUPS? 
There is only one study group in this trial. It will have all people who sign up to the trial in it and 

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will only be for information collection.  
The researchers will count all patients who have HIV and cancer at this site during the study, 
regardless of whether they agree to take part in the study. This step is for the researchers to 
understand how many people were asked to join the study, and why some people may not want to 
take part in the study. The researchers will count patients in a way that cannot be linked to your 
identity.  
WHAT EXAMS, TESTS, AND PROCEDURES ARE INVOLVED IN THIS STUDY? 
Before you begin the study, your doctor will review the results of your exams, tests, and 
procedures. This helps your doctor decide if you can take part in the study. If you join the study, 
you will have more questions about your cancer care. Choosing to take part or not in this study 
will not affect the usual care you will receive.  
WHAT RISKS CAN I EXPECT FROM TAKING PART IN THIS STUDY? 
General Risks 
If you choose to take part in this study, you may have the following discomforts: 
• Spend more time in the hospital or doctor’s office. 
• Be asked sensitive or private questions about things you normally do not discuss. 
WHAT ARE MY RESPONSIBILITIES IN THIS STUDY? 
If you choose to take part in this study, you will need to: 
• Keep your study appointments. 
• Tell your doctor about: 
o all medications and supplements you are taking 
o if you have been or are currently in another research study. 
WHAT ARE THE COSTS OF TAKING PART IN THIS STUDY? 
You will not be charged for taking part in this study. 
You and/or your insurance plan will need to pay for the costs of medical care you get as part of 
the study, just as you would if you were getting the usual care for your cancer. This includes: 
• your insurance co-pays and deductibles. 
Talk to your insurance provider and make sure that you understand what your insurance pays for 
and what it doesn’t pay for if you take part in this clinical trial. Also, find out if you need approval 
from your plan before you can take part in the study. Ask your doctor or nurse for help finding the 
right person to talk to if you are unsure which costs will be billed to you or your insurance provider. 
Taking part in this study may mean that you need to make one more visit to the clinic or hospital 
than if you were not taking part in the study.  
You may: 
• Have more travel costs. 
• Need to take more time off work. 

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AMC-S008 (Version 3.0) 22JAN2021 
• Have other additional personal costs. 
You will not be paid for taking part in this study. 
WHO WILL SEE MY MEDICAL INFORMATION? 
Your privacy is very important to us. The study doctors will make every effort to protect it. The 
study doctors have a privacy permit to help protect your records if there is a court case. However, 
some of your medical information may be given out if required by law. If this should happen, the 
study doctors will do their best to make sure that any information that goes out to others will not 
identify who you are. 
Some of your health information, such as your response to cancer treatment, results of study tests, 
and medicines you took, will be kept by the study sponsor in a central research database. However, 
your name and contact information will not be put in the database. If information from this study 
is published or presented at scientific meetings, your name and other personal information will not 
be used. 
There are organizations that may look at your study records. Your health information in the 
research database also may be shared with these organizations. They must keep your information 
private, unless required by law to give it to another group.  
Some of these organizations are: 
• The study sponsor, the National Cancer Institute (NCI) in the United States, and the groups it 
works with to review research. 
• The IRB, which is a group of people who review the research with the goal of protecting the 
people who take part in the study. 
• The AIDS Malignancy Consortium (AMC) and its representatives  
• Any local regulatory authorities who may have access to the data 
Your study records also will be stored for future use. However, your name and other personal 
information will not be used. Some types of future research may include looking at your records 
and those of other patients to see who had side effects across many studies or comparing new study 
data with older study data. However, we don’t know what research may be done in the future using 
your information. This means that: 
• You will not be asked if you agree to take part in the specific future research studies using your 
health information.  
• You and your study doctor will not necessarily be told when or what type of research will be 
done. 
• You will not get reports or other information about any research that is done using your 
information.  
WHERE CAN I GET MORE INFORMATION?  
You may visit the NCI web site at http://cancer.gov/ for more information about studies or general 
information about cancer. You may also call the NCI Cancer Information Service to get the same 
information at: 1-800-4-CANCER (1-800-422-6237). 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 

Protocol Version Date: 22JAN2021 
 
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AMC-S008 (Version 3.0) 22JAN2021 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 
You can talk to the study doctor about any questions or concerns you have about this study or to 
report side effects or injuries. Contact the study doctor (*insert name of study doctor[s]*) at 
(*insert telephone number, and email address if appropriate*). 
For questions about your rights while in this study, call the (*insert name of organization or 
center*) Institutional Review Board at (*insert telephone number*).  
^Note to Local Investigator: Contact information for patient representatives or other individuals at 
a local institution who are not on the IRB or research team but take calls regarding clinical trial 
questions can also be listed here. ^ 
Unknown future studies 
If you choose to take part in this study any health-related information, such as your response to 
cancer treatment, results of study tests, and medicines you took, will be stored for future use.  
We don’t know what research may be done in the future using your health information This means 
that: 
• You will not be asked if you agree to take part in the future research studies.  
• You and your study doctor will not be told when or what type of research will be done. 
• You will not get reports or other information about any research that is done using your 
information 
How will information about me be kept private? 
Your privacy is very important to the study researchers. They will make every effort to protect it. 
Here are just a few of the steps they will take: 
1. They will remove identifiers, such as your initials, from your information. They will replace 
them with a code number. There will be a master list linking the code numbers to names, but 
they will keep it separate from the information. 
2. Researchers who study your sample and information will not know who you are. They also 
must agree that they will not try to find out who you are. 
3. Your personal information will not be given to anyone unless it is required by law.  
4. If research results are published, your name and other personal information will not be used. 
CONTACT FOR FUTURE RESEARCH 
I agree that my study doctor, or someone on the study team, may contact me or my doctor to see 
if I wish to participate in other research in the future. 
 
YES 
 
NO 
 
 

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AMC-S008 (Version 3.0) 22JAN2021 
MY SIGNATURE AGREEING TO TAKE PART IN THE STUDY 
I have read this consent form or had it read to me. I have discussed it with the study doctor and my 
questions have been answered. I will be given a signed and dated copy of this form. I agree to take 
part in the main study 
Participant’s signature 
 
 
 
 
Date of signature 
 
 
 
 
Signature of person(s) conducting the informed consent discussion 
 
 
 
Date of signature 
 
 
 
 

Protocol Version Date: 22JAN2021 
 
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AMC-S008 (Version 3.0) 22JAN2021 
ATTATCHMENT 1: AMC CERTIFICATE OF CONFIDENTIALITY 
The NIH has given the AMC a Certificate of Confidentiality. The Certificate does not mean that 
the NIH or the U.S. Government recommend that you take part in this study. This Certificate helps 
us keep your health information private. 
Your records for this study will have information that may identify you. This Certificate lets us 
turn down legal demands for your study records. We can use the Certificate to turn down demands 
for records from a U.S. court. The Certificate can be used in any federal, state, or local legal matters 
in the United States. We will use the Certificate to turn down any demands for your study records. 
The cases where we cannot use the Certificate are explained below. 
We cannot use the Certificate to turn down a demand from the U.S. Government for study records. 
This applies to audits or reviews of the AMC. This also applies to study records that we have to 
report to the FDA. 
The Certificate does not stop you or your family members from sharing your health information. 
It does not stop you from talking about taking part in this study. You may give written permission 
for an insurer, employer, or other person to get copies of your study records. If you give 
permission, we cannot use the Certificate to say no to a request for your study records. 

AMC S008 (Version 3.0) 22JAN2021 
 
 
i 
NCI Version Date 22JAN2021 
SUMMARY OF CHANGES 
Prospective Observational Study of the Frequency of Site-Specific New and Existing Cases 
of Cancer in People Living with HIV/AIDS- in Latin America 
Version 3.0 
 
NCI Protocol #: AMC-S008 
Local Protocol #: AMC-S008 
 
NCI Version Date: 22JAN2021 
Protocol Date: 22JAN2021 
 
I. 
Scientific and Substantive Changes: 
# 
Section 
Comments 
1. 
Synopsis 
Due to delays in clinical treatment as a result of COVID-19, timelines of 
treatment and staging procedures window needs to be increased. Post visit 
follow up window has been increased to 4 weeks (+6 weeks). 
2. 
2.2 
The anticipated study duration was changed to 21 months (1 year and 9 
months) to accurately reflect the timeline for collecting new and existing 
cancer cases. Due to COVID-19 disruptions to patient referrals, routine 
clinic visits, and provider illnesses, this study should be extended by one 
year to capture patient volumes and patient cases presenting to sites as clinic 
activities begin to resume. 
3. 
3.3.1 
Due to the one-year extension of the study, additional enrollment per site is 
expected. Thus, the maximum participant enrollment has been changed 
from 200 participants to 400 participants.  
4. 
3.3.3 
Due to the increase of maximum participants, the Expected Enrollment 
Demographics table has been updated.  
 
II. 
Administrative and Editorial Changes: 
# 
Section 
Comments 
5. 
Global 
The version number and date were updated from version 2 dated 
02OCT2019 to version 3 dated TBD. 
6. 
Appendix 
III 
The AMC Data and Safety Monitoring plan was updated from version 6.0 
to the current version (9.0). Key revisions include: the addition of an 
introduction to address the variety of systems the AMC uses for individual 
trials; changes to the data entry systems used by domestic AMC trials 
(OPEN/Rave) activated September 1, 2020 and later; participation with a 

AMC S008 (Version 3.0) 22JAN2021 
 
 
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# 
Section 
Comments 
single IRB for new domestic AMC protocols; updated procedures for data 
reporting, determination of requirements for DSMB review, and safety 
review/pharmacovigilance; and administrative changes (updates to 
document organization, external links, and group terminology) and to state 
that the IRB review plan is identified in the protocol, as the AMC is opening 
international studies subject to review/requirements per their respective 
regions. 

AMC S008 (Version 3.0) TBD 
 
 
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AIDS MALIGNANCY CONSORTIUM 
 
AMC PROTOCOL S008: 
Prospective Observational Study of the Frequency of Site-Specific 
New and Existing Cases of Cancer in People Living with 
HIV/AIDS in Latin America 
A Trial of the AIDS Malignancy Consortium (AMC) 
 
Sponsored by: 
National Cancer Institute 
Office of HIV and AIDS Malignancy (OHAM) 
 
NCT Registration 
Number: 
NCT04089488 
 
 
Regulatory Status: 
Pursuant 
to 
national 
requirements 
for 
each 
participating site 
 
Protocol Chair: 
Matthew Strother, MD (IVR-48877) 
 
Protocol Co-Chair: 
Valeria Fink, MD (IVR-621276) 
Version 3.0 22JAN2021 
NCI Version Date 22JAN2021 

AMC S008 (Version 3.0) 22JAN2021 
 
 
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AMC PROTOCOL SIGNATURE PAGE 
I, ____________________, Principal Investigator at site ________, agree to conduct and follow 
this protocol: AMC Protocol S008 – Prospective Observational Study of the Frequency of 
Site-Specific New and Existing Cases of Cancer Cases in Persons Living with HIV/AIDS in 
Latin America (Version 3.0, 22JAN2021), as written according to the AMC, NCI, applicable 
national regulatory guidelines, and standards of Good Clinical Practice (GCP, ICH E6). I 
understand that no deviations from the protocol eligibility criteria or waivers for protocol 
deviations will be permitted. 
 
 
_________________________________  ______________________ 
Signature                                                         Date (DDMMMYYYY) 
 
 

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TABLE OF CONTENTS 
SUMMARY OF CHANGES ................................................................................................................ i 
AMC PROTOCOL SIGNATURE PAGE ......................................................................................... 2 
TABLE OF CONTENTS .................................................................................................................... 3 
LIST OF TABLES AND FIGURES ................................................................................................... 5 
PROTOCOL ROSTER ....................................................................................................................... 6 
PARTICIPATING CENTERS ........................................................................................................... 7 
PROTOCOL SYNOPSIS .................................................................................................................... 8 
LIST OF ABBREVIATIONS ............................................................................................................. 9 
1.0 
OBJECTIVES ........................................................................................................................ 11 
1.1 
Primary Objective ..................................................................................................11 
1.2 
Secondary Objectives.............................................................................................11 
1.3 
Exploratory Objectives ..........................................................................................11 
2.0 
BACKGROUND .................................................................................................................... 12 
2.1 
Study Disease .........................................................................................................12 
2.2 
Study Design and Rationale ...................................................................................13 
3.0 
PARTICIPANT SELECTION ............................................................................................. 15 
3.1 
Eligibility Criteria ..................................................................................................15 
3.2 
Exclusion Criteria ..................................................................................................16 
3.3 
Number of Participants to be Enrolled...................................................................16 
3.4 
Participant Enrollment Procedures ........................................................................17 
4.0 
TREATMENT PLAN ........................................................................................................... 18 
5.0 
ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS ............................. 19 
6.0 
PHARMACEUTICAL INFORMATION ........................................................................... 20 
7.0 
CLINICAL AND LABORATORY EVALUATIONS ....................................................... 21 
7.1 
Screening................................................................................................................21 
7.2 
Enrollment Data Collection ...................................................................................21 
7.3 
Follow-up Evaluations ...........................................................................................23 
8.0 
MEASUREMENT OF EFFECT .......................................................................................... 24 
9.0 
STATISTICAL CONSIDERATIONS ................................................................................. 26 
9.1 
Study Design/Endpoints and Analytic Plan ...........................................................26 
9.2 
Sample Size/Accrual Rate ......................................................................................26 
10.0 
ROLE OF DATA MANAGEMENT .................................................................................... 27 

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10.1 
CRF Instructions ....................................................................................................27 
10.2 
Data Quality ...........................................................................................................27 
10.3 
Data Monitoring .....................................................................................................27 
11.0 
ETHICAL AND REGULATORY CONSIDERATIONS .................................................. 28 
11.1 
IRB Approval and Informed Consent ....................................................................28 
11.2 
Changes to the Protocol .........................................................................................29 
12.0 
REFERENCES ...................................................................................................................... 30 
APPENDIX I: SCHEDULE OF EVALUATIONS ......................................................................... 31 
APPENDIX II: PERFORMANCE STATUS SCALES .................................................................. 32 
APPENDIX III: AMC DATA AND SAFETY MONITORING PLAN ........................................ 33 
 
 

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LIST OF TABLES AND FIGURES 
 
Table 2-A: Model Participant Data Set .................................................................................... 13 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL ROSTER 
AMC Protocol S008 
Prospective observational study of the frequency of site-specific new and existing cases of 
cancer in Persons Living with HIV/AIDS in Latin America 
 
Protocol Chair: 
Matthew Strother, MD 
Canterbury Regional Cancer & Blood Service 
Private Bag 4710 
Christchurch 8140 
New Zealand 
Tel: 254-724-67-9898 
Fax:64-3-364-0759 
Email: Matthew.strother@cdhb.health.nz 
Protocol Statistician: 
Jeannette Lee, PhD 
University of Arkansas for Medical Sciences 
Department of Biostatistics 
4301 West Markham Street, #781, Ed III, 
Room 3212 
Little Rock, AR 72205 
Tel: 501-526-6712 
Fax: 501-526-6729 
Email: jylee@uams.edu 
Protocol Co-Chair: 
Valeria Fink, MD 
Fundacion Huesped 
Carlos Gianantonio (ex Angel Peluffo) 3932 
(C1202AABB) 
Buenos Aires 
Argentina 
Tel: +54 (11) 4981-7777 
Fax: +54 (11) 4982-4024 
Email: valeria.fink@huesped.org.ar 
Data Management/Operations: 
AMC Operations and Data Management 
Center 
The Emmes Company, LLC 
401 N. Washington Street, Suite 700 
Rockville, MD 20850 
Tel: (301) 251-1161 
Fax: (240) 238-2842 
Email: amipm@emmes.com 
 
 
 

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PARTICIPATING CENTERS 
 
Complexo Hospitalar Universitario 
Professor Edgar Santos: 
Rua Augusto Viana 
CEP 40110-060 
Salvador, Brazil 
Tel: 55 (71) 3235-4901 
Instituto Nacional de Cancer Jose de 
Alencar: 
Rua Andre Cavalcanti, 37 
Rio de Janeiro, Brazil 20231-050 
Tel: +55 (21) 3207-6557 
Instituto Nacional de Cancerologia: 
Avenida San Fernando 22 
Belisario Dominguez Secc 16, 14080 
Ciudad de Mexico, Mexico 
Tel: +52 (55) 5628-0400 Ext. 12120 
Fundacion Huesped: 
Pasaje Carlos Gianantonio (ex A. Peluffo) 
3932 (C1202AABB) 
Buenos Aires, Argentina 
Tel: +54 (11) 4981-7777 
 
Contact information is subject to change. For current contact information for clinical sites, please 
see the protocol roster in the password-protected section of the AMC Operations web site at 
www.AIDSCancer.org. 

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PROTOCOL SYNOPSIS 
Title: 
Prospective observational study of the frequency of site-specific 
new and existing cases of cancer in People Living with 
HIV/AIDS in Latin America 
Design: 
Observational prospective cohort 
Accrual Target: 
Minimum of 10 cases per participating site; maximum of 400 
participants across all centers 
Regulatory Status: 
Pursuant to national requirements for each participating site 
Population: 
Participants presenting to HIV treatment programs or cancer 
treatment programs at collaborating sites, with both HIV and 
cancer, which may include either a history of malignancy or 
current diagnosis. 
Regimen: 
Non-interventional. Data collection will occur via survey 
procedures and/or medical record review at screening, 
enrollment, and if available, at 4 weeks following enrollment (+6 
weeks). 
Anticipated Trial 
Duration: 
1 year, 9 months 
Primary Objective: 
To determine the frequency of new and existing diagnosed HIV-
associated cancers presenting at participating clinical sites in 
Latin America,  based on all presenting cancers (new diagnosis, 
recurrence, and surveillance cases as defined in Section 3.1.2)  
Secondary Objectives: 
• Obtain information on the use of diagnostic testing and 
treatment for the cohort of diagnosed cancers in people living 
with HIV/AIDS. 
• To collect current information on participant characteristics 
for diagnosed cancers in people living with HIV/AIDS (e.g., 
ART regimen, CD4 count, viral load, etc.) 
Exploratory Objectives 
• To determine the timelines and requirements for protocol 
review and approval at the local, regional, and national level. 
• To familiarize local sites with the online data entry systems 
used by the AMC. 

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LIST OF ABBREVIATIONS 
ACSR 
AIDS and Cancer Specimen Resource 
AE 
Adverse event 
AIDS 
Acquired immunodeficiency syndrome 
AMC 
AIDS Malignancy Consortium 
ANC 
Absolute neutrophil count 
ART 
Antiretroviral therapy 
CBC 
Complete blood count 
CDC 
Centers for Disease Control and Prevention 
CDUS 
Clinical Data Update System 
CIA 
Chemiluminescent Immunoassay 
CR 
Complete response 
CRF 
Case report form 
CTEP 
Cancer Therapy Evaluation Program 
CTEP-AERS 
Cancer Therapy Evaluation Program Adverse Event Reporting System 
DARF 
Drug accountability record form 
DHHS 
Department of Health and Human Services 
DNA 
Deoxyribonucleic acid 
DSMB 
Data and Safety Monitoring Board 
ECOG 
Eastern Cooperative Oncology Group 
EIA 
Enzyme Immunoassay 
FDA 
Food and Drug Administration 
FTP 
File transfer protocol 
HIV 
Human immunodeficiency virus 
IEC 
Institutional ethics committee 
IC 
Institution and Center 
IRB 
Institutional review board 
IND 
Investigational new drug 
KPS 
Karnofsky performance score 
NCI 
National Cancer Institute 
ODMC 
Operations and Data Management Center 

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PCR 
Polymerase chain reaction 
PLWHA 
People living with HIV/AIDS 
PR 
Partial response 
REB 
Research ethics board 
RNA 
Ribonucleic acid 
SAE 
Serious adverse event 
SOP 
Standard Operating Procedure 
WHO 
World Health Organization 
 
 

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1.0 
OBJECTIVES 
1.1 
Primary Objective 
To determine the frequency of new and existing diagnosed cancers in PLWHA presenting 
to participating clinical sites in Latin America, based on all presenting cancers (new 
diagnosis, recurrence, and surveillance cases as defined in Section 3.1.2). 
1.2 
Secondary Objectives 
1.2.1 Obtain information on the use of diagnostic testing and treatment for the cohort of 
diagnosed HIV-associated cancer participants. 
1.2.2 To collect current information on participant characteristics for diagnosed HIV-
associated cancers (e.g., ART regimen, CD4 count, viral load, etc.) 
1.3 
Exploratory Objectives 
1.3.1 To determine the timelines and requirements for protocol review and approval at 
the local, regional, and national level. 
1.3.2 To familiarize local sites with the online data entry systems used by the AMC. 
 
 

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2.0 
BACKGROUND 
2.1 
Study Disease 
The AIDS Malignancy Consortium (AMC), as part of its international agenda, is extending 
its research network into Latin America (LA) and has added 4 sites in the region as of 
September 1, 2018. Building on lessons learned in the site selection and implementation of 
clinical trials in Africa, the AMC will utilize a non-interventional, registration-type study 
to prospectively gather information over a limited time frame on the presentation, 
evaluation, and treatment of participants newly presenting with HIV-associated cancers 
(new diagnosis or relapsed/recurrent, excluding dysplasia) that will help to inform the 
development of future AMC therapeutic trials in LA. 
The AMC expansion into LA is supported by the following observations: first, HIV 
remains common in the region; second, successful HIV treatment programs have resulted 
in longer survival among people living with HIV/AIDS (PLWHA) and leading to increased 
cancer incidence; third, regional investment in research and treatment of cancer, and HIV-
related malignancy in specific, has been limited. In 2015, there were an estimated 2 million 
PLWHA in LA, 100,000 new HIV infections, and 50,000 AIDS related deaths1. This region 
has been successful in implementing HIV diagnostic and treatment programs, with an 
estimated 70% of PLWHA diagnosed, and 44% of eligible adults treated with anti-
retroviral therapy (ART)2. A recent analysis comparing Latinos in LA versus North 
America found this population had better continuity of treatment, but conversely had higher 
mortality, particularly in the first year on ART3. Quantifying the impact of cancer on HIV 
outcomes is hobbled by a dearth of data in this area. 
Publications about cancer amongst PLWHA in LA are very limited. The most 
comprehensive study to date described a cohort of 428 patients with 455 cancers or pre-
cancerous lesions amongst the 3372 patients within the Caribbean, Central and South 
America Network for HIV Research (CCASAnet)4. Of the 406 cancers, 82% were AIDS-
defining, predominantly Kaposi sarcoma and non-Hodgkin lymphoma, and 18% were Non-
AIDS Defining (NADC), predominantly Hodgkin’s lymphoma and skin cancers. 
Approximately half the patients received cancer-specific treatment (chemotherapy, 
radiotherapy, or combination), with under half of patients reported cured, one-third 
persistent, and the remainder with unknown outcome. However, improving these outcomes 
is presently limited by a lack of clinical trials for HIV related cancers in the region. 
A Lancet Oncology Commission in 2013 found several hurdles to clinical cancer research 
in the region, including too few cancer care specialists, limited local expertise in research, 
and fragmented healthcare systems5. A 2015 report by the same body optimistically noted 
an increased number of oncologists, expansion of cancer registries, and improved national 
policies and access to care6. However, the report still highlighted fragmentation within the 
healthcare system between urban and rural settings and across the public and private health 
systems. Further, it was emphasized that there remained inadequate cancer research 
expertise and infrastructure. This finding in particular highlights the importance of the 
AMC’s proposal to develop research sites in LA, but also highlights the importance of 
understanding the movement of patients through the health care system to ensure the 
success of this effort. 
The expansion into Sub-Saharan Africa (SSA) emphasized that a structured understanding 

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of the health delivery services at new collaborating sites is critical to successful 
partnerships. Building on our prior experience and lessons learned from SSA, allowing 
targeted strategic investment in education and infrastructure, we propose a non-
interventional registration study that will provide practical information about HIV and 
cancer care, research infrastructure, and the management of HIV+ cancer patients, while 
also introducing the new AMC sites to the group’s online data entry system. 
2.2 Study Design and Rationale 
This protocol will develop a prospective cohort of newly diagnosed and previously 
diagnosed cancers in each site’s HIV patient populations. 
Following local/regional/national regulatory approval of this protocol, sites will be asked 
to prospectively capture cancer diagnoses in the setting of HIV infection, that present to 
the sites. The convenience sampling used in this protocol will only capture participants 
presenting at participating centers and will not actively identify participants in historical 
records. Data collection will occur over a period of 1 year, and 9 months. All participants 
presenting to sites with a diagnosis of HIV-associated cancer will be asked to participate. 
All patients presenting to the clinic with HIV and a diagnosis of malignancy will be 
recorded on a screening list. In participants who consent to participate in the data collection, 
data captured will include, but not be limited to, the following: 
Table 2-A: Model Participant Data Set 
Demographics Age, sex, etc. 
HIV Care 
Whether current HIV care is being received at the enrolling institution, 
current ART regimen, date of diagnosis, method of diagnosis, current 
OIs, current medications, recent viral load, CD4 count 
Status of 
Diagnosis 
New Diagnosis, pre-treatment phase, and treatment phase 
Prior Diagnosis, in remission (within 5 years of initial diagnosis) 
Prior Diagnosis, recurrent, pre-treatment, treatment phase, or no 
treatment planned 
Cancer 
Diagnosis 
Cancer diagnosis, date cancer diagnosed, diagnostic methods (cytology, 
histology), pathology performed, date of pathology, staging, staging 
methods (clinical, radiographic, surgical), date(s) of staging (new and 
recurrent cancer only), current ECOG PS, current laboratory values 
Cancer 
Treatment 
Plan 
Detailed prior/planned treatment (e.g., chemotherapy, radiation, surgery, 
or best supportive care/watchful waiting). Whether current cancer care 
is being received or will occur at the enrolling institution. Timeline of 
planned treatment (i.e., start date). 
For participants initiating therapy (new or recurrent) or currently under treatment, a short 
interval follow-up (approximately 1-3 months), will be used to ascertain the current vital 
status, and current state of planned cancer therapy. The data collected at this later time point 
will be limited, as the intent of this data capture is to ascertain the relationship between 
planned therapy and therapy received. These data will include any cancer-specific therapy 
initiated since registration, the start date of that therapy, and whether the therapy has had 
significant delays to initiation or interruptions of therapy.  

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Please see Section 7.2 for specific data to be collected during this protocol.  

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3.0 
PARTICIPANT SELECTION 
A rostered AMC investigator (CTEP-registered physician investigator or Non-Physician 
Investigator) or delegated clinical staff (CTEP-registered Associate Plus) must document 
that each protocol participant meets all stated eligibility criteria. Participating sites must 
have documentation that each eligibility requirement is satisfied prior to participant 
enrollment. In compliance with CTEP policy, no exceptions to eligibility criteria will be 
granted under any circumstance. 
NOTE: Institutions may use this section of the protocol as an eligibility checklist for source 
documentation if it has been reviewed, signed, and dated before registration/randomization 
by the study investigator. If used as source documentation, this checklist must be printed, 
the investigator must check each item to document their assessment that the participant 
meets each eligibility criterion, and the completed checklist must be maintained in the 
participant’s chart. 
Participant ID Number: S008 - ___ ___ ___ - ___ ___ ___ ___ ___ 
Participant’s Initials (L, F, M [optional]): ___ ___ ___ 
NOTE: All questions regarding eligibility should be directed to the study chair. 
3.1 
Eligibility Criteria 
____ 3.1.1 HIV positive. Documentation of HIV-1 infection by means of any one of the 
following: 
• Documentation of receipt of ART by a licensed health care provider 
(Documentation may be a record of an ART prescription in the participant’s 
medical record, a written prescription in the name of the participant for ART, 
or pill bottles for ART with a label showing the participant’s name); 
• HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 
RNA copies/mL, and supported by a licensed screening antibody and/or HIV 
antibody/antigen combination assay; 
• Any licensed HIV screening antibody and/or HIV antibody/antigen 
combination assay confirmed by a second licensed HIV assay, such as a HIV-
1 Western blot confirmation or HIV rapid multispot antibody differentiation 
assay. 
Note: The term “licensed” refers to a kit that has been certified or licensed by an 
oversight body within the participating country and validated internally. 
WHO (World Health Organization) and CDC (Centers for Disease Control and 
Prevention) guidelines mandate that confirmation of the initial test result must use 
a test that is different from the one used for the initial assessment. A reactive initial 
rapid test should be confirmed by either another type of rapid assay or an E/CIA 
that is based on a different antigen preparation and/or different test principle (e.g., 
indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load. 
____ 3.1.2 
Must have a current or prior (within the last 5 years) diagnosis of cancer – but there 
is no restriction of the number or type of prior treatments. Participants will qualify 
under one of three categories: 

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• New diagnosis – no prior treatment for current malignancy. May be prior to, or 
currently receiving the first line of therapy.  
• Prior diagnosis (within 5 years), in remission – Not currently on cancer 
treatment other than cART. Prior treatment for malignancy can include surgery, 
radiation, or chemotherapy (or cART initiation in KS). No restriction on number 
of prior lines of therapy.  
• Prior diagnosis, recurrent – Considering or currently receiving treatment that is 
not first line. No restriction on the number of prior lines of therapy 
____ 3.1.3 Age > 18 years. Date of birth and age should be determined based on best possible 
information or documentation available. 
____ 3.1.4 Ability to understand and the willingness to provide informed consent document. 
3.2 
Exclusion Criteria 
Participants not meeting all criteria above in Section 3.1 are ineligible. 
3.3 
Number of Participants to be Enrolled 
NIH policy requires that women and members of minority groups and their subpopulations 
be included in all NIH-supported biomedical and behavioral research projects involving 
NIH-defined clinical research unless a clear and compelling rationale and justification 
establishes to the satisfaction of the funding Institute & Center (IC) Director that inclusion 
is inappropriate with respect to the health of the participants or the purpose of the research. 
Exclusion under other circumstances must be designated by the Director, NIH, upon the 
recommendation of an IC Director based on a compelling rationale and justification. Cost 
is not an acceptable reason for exclusion except when the study would duplicate data from 
other sources. Women of childbearing potential should not be routinely excluded from 
participation 
in 
clinical 
research. 
Please 
see 
http://grants.nih.gov/grants/funding/phs398/phs398.pdf. 
3.3.1 Proposed sample size 
This study will enroll a minimum of 10 participants per site. If fewer than 10 
participants are identified at a site, the AMC will work with site on improvement 
of potential participant identification. A maximum of 400 participants will be 
accepted for this registration study. Accrual will be completed once the target trial 
duration has elapsed. 
3.3.2 Accrual rate 
Approximately 2 participants per month per site. 
 
 

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3.3.3 Expected Enrollment Demographics 
INTERNATIONAL PLANNED ENROLLMENT REPORT (TREATMENT) 
Racial 
Categories 
Ethnic Categories 
Total 
Not Hispanic or Latino 
Hispanic or Latino 
Female 
Male 
Female 
Male 
Indigenous 
0 
0 
14 
26 
40 
Asian 
0 
0 
0 
4 
4 
Native 
Hawaiian or 
Other Pacific 
Islander 
0 
0 
0 
0 
0 
Black 
or 
African 
0 
0 
6 
10 
16 
White 
0 
0 
50 
110 
160 
More 
Than 
One Race 
0 
0 
60 
120 
180 
Total 
0 
0 
130 
270 
400 
 
3.4 
Participant Enrollment Procedures 
Sites must have this protocol approved by their Institutional Review Boards (IRB) and be 
registered for study participation with the AMC Operations and Data Management Center 
(ODMC) before they may enroll participants. 
After it has been determined that the participant is eligible and an informed consent form 
has been signed by the participant, the participant must be registered on-line via the AMC 
Advantage eClinicalSM Internet Data Entry System (Advantage eClinical). Enrollment and 
data collection will occur via the AMC Internet Data Entry System. 
The participating site will ensure a participant meets all eligibility criteria prior to 
completing the protocol-specific eligibility checklist in Advantage eClinical for 
enrollment. Participants must be enrolled on-line via Advantage eClinical within 1 week 
of consent. Once the eligibility checklist is submitted a system-generated confirmation 
email will be sent to the enroller upon successful completion of the participant enrollment. 
If the on-line system is inaccessible, the site should notify the AMC ODMC (via email at 
amipm@emmes.com or via phone at 001-301-251-1161) for further instructions. 

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4.0 
TREATMENT PLAN 
This is a descriptive study. No intervention will be administered as part of this protocol. 
Please refer to the clinical and laboratory evaluations and statistical sections for a 
description of the trial procedures. 
 
 

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5.0 
ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS 
As this study is non-interventional and focuses on data collection for cancer diagnosis and 
treatment initiation with limited follow-up, no adverse event data will be collected. 
 
 

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6.0 
PHARMACEUTICAL INFORMATION 
Not applicable (non-interventional study). 
 
 

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7.0 
CLINICAL AND LABORATORY EVALUATIONS  
Evaluations required for this protocol are enumerated below and summarized in the 
Schedule of Events in Appendix I. 
7.1 
Screening 
All presenting HIV+ participants with a histologically confirmed diagnosis of cancer 
(prior, within 5 years, or current) will be tracked on a screening list and approached to 
participate in AMC-S008. 
To determine the types of cancer cases that present to the clinical sites, it is requested that 
all participants presenting at these sites have a minimum set of data collected. As this will 
be performed prior to formal consent, this data collection will be done in a de-identified 
fashion. Data collected on participants presenting to the clinical site will include the 
participant’s age, sex at birth, and type of cancer. This information will be maintained 
separately from data on enrolled cases and will not be recorded with any codes or data 
elements that could be linked to the participant’s identity. This data will be compared to 
the total number of enrolled participants at each site to estimate the proportion of 
participants who consent to participate in this trial. 
7.2 
Enrollment Data Collection 
Following informed consent, additional, identifiable data will be collected, as outlined 
below. 
7.2.1 Age, date of birth, sex at birth 
7.2.2 Whether current HIV care is being received at the enrolling institution, current ART 
regimen, data of HIV diagnosis, method of HIV diagnosis, current opportunistic 
infections, current medications. 
7.2.3 Current ECOG performance status (see Appendix II) 
7.2.4 Estimated life expectancy 
7.2.5 Status of cancer diagnosis (one of the following) 
• New diagnosis, pre-treatment phase 
• New diagnosis, treatment phase 
• Prior diagnosis, in remission (within 5 years of initial diagnosis) 
• Prior diagnosis, recurrent, pre-treatment phase 
• Prior diagnosis, recurrent, treatment phase 
• Prior diagnosis, recurrent, no treatment planned 
7.2.6 For participants with a new diagnosis (pre-treatment or treatment), the following 
will be collected: 
7.2.6.1 Cancer diagnosis, date of diagnosis, method of diagnosis (cytology, 
histology), type of pathology performed (H&E, immunohistochemistry, 
other), data of pathology, staging, staging methods (clinical, radiographic, 
surgical), date(s) of staging, most recent laboratory values (this would 

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include complete blood count, renal and liver function, electrolytes, CD4 
count, and HIV viral load). 
7.2.6.1 Detailed planned or current treatment. This should encompass surgical 
interventions, radiotherapy, and chemotherapy (agent names), including 
dates of planned or current therapy, and whether cancer care is being 
received or will occur at the enrolling institution. 
7.2.7 For participants with a prior diagnosis in remission, the following will be collected: 
• Cancer diagnosis, date of diagnosis 
• Current method of post-treatment surveillance (clinical, laboratory, 
radiographic), and current schedule of follow-up with this center, current 
laboratory values (this would include complete blood count, renal and liver 
function, electrolytes, CD4 count, and HIV viral load). 
• Prior method of diagnosis (cytology, histology), pathology performed, date of 
pathology, staging, staging methods (clinical, radiographic, surgical). Records 
from a prior diagnosis/treatment should be requested, but if they are 
unavailable, participant report will be sufficient. 
• Prior treatment. This should encompass surgical interventions, radiotherapy, 
and chemotherapy. Records from a prior diagnosis/treatment should be 
requested, but if they are unavailable, participant report will be sufficient. 
7.2.8 For participants with a prior diagnosis, recurrent (pre-treatment, treatment, or no 
planned treatment) the following will be collected: 
• Initial cancer diagnosis, date of diagnosis 
• Prior method of diagnosis (cytology, histology), pathology performed, date of 
pathology, staging, staging methods (clinical, radiographic, surgical), date(s) of 
staging. Records from a prior diagnosis/treatment should be requested, but if 
they are unavailable, participant report will be sufficient. 
• Prior treatment. This should encompass surgical interventions, radiotherapy,  
and chemotherapy. Records from a prior diagnosis/treatment should be 
requested, but if they are unavailable, participant report will be sufficient. 
• Current date of cancer diagnosis, method of diagnosis (clinical, cytology, 
histology), pathology performed, date of pathology, staging, staging methods 
(clinical, radiographic, surgical), date(s) of staging, current ECOG Performance 
Status (PS), current laboratory values (this would include complete blood count, 
renal and liver function, electrolytes, CD4 count, and HIV viral load). 
• IF THERAPY IS PLANNED OR UNDERWAY: Detailed planned or current 
treatment. This should encompass surgical interventions, radiotherapy, and 
chemotherapy, dates of planned or current therapy, and whether cancer care is 
being received or will occur at the enrolling institution.  
• IF NO THERAPY IS PLANNED: Reason for no further therapy, e.g., if the 
decision for no therapy is based on lack of options for treatment, lack of benefit 

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of further treatment, or participant choice not to pursue further treatment.  
7.3 
Follow-up Evaluations 
For any participants enrolled in AMC-S008, with either planned or current therapy, for 
both new diagnosis and prior diagnosis, recurrent, a short interval follow-up will be 
conducted at 4 weeks  (+ 6 weeks). Participants can be contacted in person during a planned 
return visit within this window or can be contacted by telephone if no further clinical 
appointments occur within this window. If the participant cannot be reached and the 
information is available in an electronic medical file, this follow up can occur passively 
via review of medical records. 
7.3.1 Is the participant still in follow-up? Last date participant seen in clinic. Current vital 
status, current ECOG PS. 
7.3.2 Current status of treatment plan: planned, no longer planned, ongoing, completed. 
7.3.3 For participants in whom treatment is still planned. 
• Has the planned therapy changed since enrollment?  
• Is the planned start date the same as prior? 
• If the planned start date has changed, the reason. 
7.3.4 For participants in whom treatment is no longer planned. 
• Why the treatment is no longer planned?  
7.3.5 For participants in whom treatment is in process. 
• Is the current therapy different than the prior planned treatment? 
• Start date of current therapy? 
• If start date changed, the reason. 
• Have there been any delays in treatment thus far, and if so, why? 
7.3.6 For participants who have completed therapy. 
• Date therapy completed. 
• Was therapy completed because planned treatment had been achieved, treatment 
determined to not be of benefit, change to new therapy based on toxicity or 
progression, or another factor? 
 
 

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8.0 
MEASUREMENT OF EFFECT 
This is a non-interventional protocol. All data reported on the effect of prior treatment for 
malignancy will be reported based on existing medical records or the local standard of care. 
The following definitions will be employed for case classification and data reporting. 
First-line therapy 
All therapy performed as part of a treatment plan with a new 
diagnosis of cancer, including surgery, radiotherapy, and 
chemotherapy, alone or in combination. 
Therapeutic encounter The period between initiation of a planned therapy and 
completion of that episode of planned therapy. If the planned 
therapy changes due to changing clinical circumstances, this is 
now a new therapeutic encounter (e.g., with progression on 
first-line therapy R-CHOP, the next treatment is a new 
therapeutic encounter). 
Site-specific 
frequency 
of 
new 
cases 
Total number of participants that present to the site with a first 
diagnosis of cancer. This encompasses the period from 
histologically proven cancer to completion of planned first-line 
therapy or discharge with no anti-cancer treatment planned. 
Site-specific 
frequency of new and 
existing cases 
Total number of participants that present to the site with a 
diagnosis of cancer within the last 5 years. This includes 
participants in treatment, surveillance, or best supportive care.  
New diagnosis 
Status that includes the period from histologically proven 
cancer to completion of all planned first-line therapy.  
A second malignancy will be captured as a new diagnosis. 
Examples include a transformed lymphoma in the setting of the 
low-grade lymphoma or development of vulvar cancer in the 
setting of a history of treated cervical cancer. 
Prior 
diagnosis, 
in 
remission 
Status that includes the period from completion of first-line 
therapy until evidence of disease progression. This could 
encompass participants with no evidence of disease or stable 
disease that is not progressing. 
Prior 
diagnosis, 
recurrent 
Status that includes the period following evidence of 
progression of the previously diagnosed cancer in a participant 
who has completed a prior therapy. 
This does not encompass new second malignancies. 
Pre-treatment phase 
The period in which a participant has a histologically diagnosed 
cancer, with cancer-specific treatment planned but not yet 
initiated. 
Treatment phase 
The period in which the participant has started therapy for 
cancer. 
This 
can 
include 
surgery, 
radiation, 
and/or 
chemotherapy. This period completes when all planned therapy 
has been completed within a therapeutic encounter. 
No treatment planned 
The point at which no further active cancer treatments are 

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planned. Initiation of best supportive care or palliative care.  
 
 

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9.0 
STATISTICAL CONSIDERATIONS 
9.1 
Study Design/Endpoints and Analytic Plan 
This study will utilize a prospective cohort design to identify the frequency of new and 
existing cancer cases among PLWHA receiving care at the site. 
The primary endpoint will be the estimates of site-specific frequency of new and existing 
cases presenting with HIV and cancer presenting over 1 year, 9 months at the clinical sites. 
For each geographic site and type of cancer, the number of new and existing cancer cases 
will be estimated using a 95% Poisson confidence interval. 
Secondary endpoints will include: 
• Information on the use of diagnostic testing and treatment for cancers diagnosed in 
HIV-positive individuals. The frequency of diagnostic testing modalities and cancer 
treatment regimens will be summarized for cancer. 
• Current information on the HIV treatment and disease characteristics (e.g., ART 
regimen, CD4 count, viral load, etc.) of HIV-positive individuals diagnosed with 
cancer. For each cancer, summary statistics will be used to describe the HIV 
treatment regimens and disease characteristics. 
Exploratory endpoints will include: 
• Timelines and requirements for protocol review and approval at the local, regional, 
and national level. 
• The familiarization of local sites with the online data entry systems used by the AMC. 
9.2 
Sample Size/Accrual Rate 
2 participants per month, per site. 
This study will enroll a minimum of 10 participants per site. If fewer than 10 participants 
are identified at a site, the AMC will work with site on improvement of potential participant 
identification. A maximum of 400 participants will be accepted for this registration study. 
 
 
 

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10.0 
ROLE OF DATA MANAGEMENT 
10.1 
CRF Instructions 
Access to the internet data entry system for this study, Advantage eClinical, and 
instructions for recording of study data on CRFs will be provided by the AMC ODMC at 
www.amcoperations.com. Participating institutions are responsible for submitting data 
and/or data forms via Advantage eClinical in accordance with the AMC Data Entry Guide 
and specific form instructions, within the timelines specified by the AMC’s Standards of 
Procedure for Site Performance Measures. 
10.2 
Data Quality 
It is the responsibility of the AMC ODMC to assure the quality of data for the study (See 
Appendix III, AMC Data and Safety Monitoring Plan). This role extends from protocol 
development to generation of the final study database. 
10.3 
Data Monitoring 
This study will be monitored in compliance with AMC policies and by the Clinical Data 
Update System (CDUS) Version 3.0. Cumulative protocol- and participant-specific CDUS 
data will be submitted electronically to CTEP on a quarterly basis. Reports are due January 
31, April 30, July 31, and October 31. Instructions for submitting data using the CDUS can 
be found on the CTEP Web site (http://ctep.cancer.gov/reporting/cdus.html). 
The AMC ODMC is responsible for compiling and submitting CDUS data to CTEP for all 
participants and for providing the data to the Principal Investigator for review. 

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11.0 
ETHICAL AND REGULATORY CONSIDERATIONS 
11.1 
IRB Approval and Informed Consent 
The principles of Institutional Review Board (IRB) approval and informed consent 
described in the Department of Health and Human Services (DHHS) regulations for the 
Protection of Human Subjects regulations (45 CFR Part 46) must be followed. 
IRB/institutional ethics committee (IEC) approval of the protocol and the informed consent 
form must be given in writing. 
The sponsor’s designee (AMC ODMC) must receive a copy of the letter of approval from 
the IRB, which specifically approves the protocol and informed consent, before participant 
enrollment. The IRB must also approve any significant changes to the protocol and 
documentation of this approval must be sent to the AMC ODMC. The IRB must review 
the research project at least once every 365 days during the duration of the project. 
Continuing approval of the project must also be given in writing and provided to the AMC 
ODMC. 
Records of all study review and approval documents must be kept on file by the 
Investigator and are participant to inspection during or after completion of the study. AEs 
must be reported to the IRB according to local procedures. The IRB should receive 
notification of completion of the study and final report within 3 months of study completion 
and termination. The Investigator will maintain an accurate and complete record of all 
submissions made to the IRB, including a list of all reports and documents submitted. 
Written informed consent will be obtained from all participants who will be enrolled for 
data collection per section 7.2. The nature, significance and risks associated with the study 
must be explained to the participant. The informed consent will describe the purpose of the 
study, the procedures to be followed, the risks and benefits of participation as listed in the 
model informed consent form, and all other elements of informed consent as required by 
regulation. A copy of the consent form will be given to the participant to keep. 
The activities described in Section 7.1 for tracking screened cases preceding trial entry list 
qualify as exempt human subjects research under 45 CFR 46.101(b)(4) as the data collected 
will be limited to the age, sex at birth, and cancer diagnosis for patients who present to the 
clinic with diagnoses of cancer and HIV infection. The data will be recorded in a manner 
that is not linked to any other information in the patient’s medical records or enrollment in 
the trial. This data will be used solely to estimate the number and types of cancer cases that 
present to the site, and to estimate the proportion of cases who consent for enrollment for 
data collection, as compared to the total number of enrolled cases. 
11.1.1 Local, regional, and/or national regulatory review 
In addition, any institution(s) conducting research according to the guidelines of 
this protocol is required to adhere to local, regional, and national laws and 
regulations governing the conduct of clinical trials involving human subjects, and 
the confidentiality and disclosure of health information. Each participating center 
will be responsible for ensuring compliance with applicable law for its respective 
locality. Documentation regarding the approval of the competent authority or 
exemption from further review will be required for protocol activation. 

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In the event that the local IRB or competent authority for the region requires a 
waiver of informed consent for the activities described in Section 7.1 for tracking 
screening cases preceding trial entry, the site will be required to obtain this approval 
before the site may initiate protocol data collection. 
11.2 
Changes to the Protocol 
Any change or addition to this protocol requires a written protocol amendment that must 
be approved by CTEP and the Investigator before implementation. All amendments require 
approval by the IRB/IEC of the treating institution. A copy of the written approval of the 
IRB/IEC and the national regulatory body (if applicable) must be sent to the ODMC. 

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12.0 REFERENCES 
1. UNAIDS Fact Sheet 2016: 2030 – Ending the AIDS Epidemic; 2015 Global Statistics. 
Available at: 
http://www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf. 
(Accessed: 3rd February 2018) 
2. Perez, F., Gomez, B., Ravasi, G. & Ghidinelli, M. Progress and challenges in implementing 
HIV care and treatment policies in Latin America following the treatment 2.0 initiative. 
BMC Public Health 15, (2015). 
3. Cesar, C. et al. Health outcomes among HIV-positive Latinos initiating antiretroviral therapy 
in North America versus Central and South America. J. Int. AIDS Soc. 19, 20684 (2016). 
4. Fink, V. I. et al. Cancer in HIV-Infected Persons from the Caribbean, Central and South 
America: JAIDS J. Acquir. Immune Defic. Syndr. 56, 467–473 (2011). 
5. Goss, P. E. et al. Planning cancer control in Latin America and the Caribbean. Lancet Oncol. 
14, 391–436 (2013). 
6. Strasser-Weippl, K. et al. Progress and remaining challenges for cancer control in Latin 
America and the Caribbean. Lancet Oncol. 16, 1405–1438 (2015). 

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APPENDIX I: SCHEDULE OF EVALUATIONS 
The schedule of evaluations below applies to all participants on study.  
 
Pre-Study 
Enrollment 
Week 4 (+ 6 weeks)* 
Informed consent 
X 
 
 
Demographics 
X 
 
 
HIV history 
 
X1 
 
Cancer history 
 
X1 
X2 
Performance status 
 
X 
X 
Laboratory data collection 
 
X1 
X2 
* Subjects in whom no further treatment is planned after enrollment do not require the 
week 4 follow-up 
1Please see Section 7.2 for specific records to be collected. 
2Please see Section 7.3 for specific records to be collected. 
 
 

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APPENDIX II: PERFORMANCE STATUS SCALES 
Karnofsky Performance Scale 
ECOG Performance Status Scale 
Percent 
Description 
Grade 
Description 
100 
Normal, no complaints, no 
evidence of disease. 
0 
Normal activity. Fully active, able to 
carry on all pre-disease performance 
without restriction. 
90 
Able to carry on normal activity; 
minor signs or symptoms of 
disease. 
80 
Normal activity with effort; some 
signs or symptoms of disease. 
1 
Symptoms, but ambulatory. 
Restricted in physically strenuous 
activity, but ambulatory and able to 
carry out work of a light or 
sedentary nature (e.g., light 
housework, office work). 
70 
Cares for self, unable to carry on 
normal activity or to do active 
work. 
60 
Requires occasional assistance, 
but is able to care for most of 
his/her needs. 
2 
In bed <50% of the time. 
Ambulatory and capable of all self-
care, but unable to carry out any 
work activities. Up and about more 
than 50% of waking hours. 
50 
Requires considerable assistance 
and frequent medical care. 
40 
Disabled, requires special care and 
assistance. 
3 
In bed >50% of the time. Capable of 
only limited self-care, confined to 
bed or chair more than 50% of 
waking hours. 
30 
Severely disabled, hospitalization 
indicated. Death not imminent. 
20 
Very sick, hospitalization 
indicated. Death not imminent. 
4 
100% bedridden. Completely 
disabled. Cannot carry on any self-
care. Totally confined to bed or 
chair. 
10 
Moribund, fatal processes 
progressing rapidly. 
0 
Dead. 
5 
Dead. 
 
 

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APPENDIX III: AMC DATA AND SAFETY MONITORING PLAN 
(Version 9.0  October 6, 2020) 
 
Introduction 
The AIDS Malignancy Consortium (AMC) Data and Safety Monitoring Plan (DSMP) outlines the 
measures employed by the group to monitor the safety of participants and ensure the data validity 
and integrity for all clinical trials it conducts. This includes methods to: 1) monitor the progress of 
trials and the safety of participants; 2) comply with regulatory requirements for adverse event (AE) 
reporting; 3) processes for trial termination or temporary suspension and major modifications; and 
4) plans for ensuring data accuracy and protocol compliance. As the AMC conducts protocols of 
varying research phase, region of conduct (which may include trials conducted in the U.S., 
international sites, or both), IND sponsor (AMC investigator, CTEP, or industry-sponsored) and 
clinical data entry system use, this plan addresses broad processes applying to the range of trial 
designs and requirements. Refer to the individual AMC protocol to identify the applicable study 
characteristics for the relevant requirements described in this plan. 
Monitoring the Progress of Trials and the Safety of Participants 
Routine and expedited AE reporting 
All AMC protocols that collect safety data adhere to the National Cancer Institute (NCI), Cancer 
Therapy Evaluation Program (CTEP) Guidelines: Adverse Event Reporting Requirements 
(https://ctep.cancer.gov/protocolDevelopment/adverse_effects.htm), as applicable to the clinical 
protocol. AEs are to be recorded in the source documents, assessed by a clinical investigator for 
the AE reporting criteria, and promptly reported in the clinical data entry system as required by 
each protocol. For AMC trials conducted under a CTEP IND and AMC trials conducted within the 
U.S., all AEs that meet the NCI’s expedited reporting requirements are reported to the NCI via the 
CTEP Adverse Event Reporting System (CTEP-AERS) web application, either directly or through 
integration with Medidata Rave where this system is employed for AMC protocols. Use of this 
system ensures notification to the protocol chair and Investigational Drug Branch (IDB) at CTEP, 
as required for trials conducted under a CTEP IND, and a uniform expedited reporting and safety 
review process for AMC domestic trials. The system may also be programmed to include sponsor 
notification as required for trials with industry support. Alternate process for expedited AE 
reporting to the AMC protocol chairs and AMC Operations and Data Management Center 
(ODMC) within the clinical data entry system (AdvantageEDC or Advantage eClinical only) may 
be defined in the protocol for select trials (international studies and The ANCHOR Study). 
All serious adverse events (SAEs) received by the AMC ODMC will be reviewed by the AMC 
medical monitor at the AMC ODMC for consideration of individual participant safety, safe trial 
conduct, data reporting quality for AE term selection, and appropriate application of the regulatory 
criteria for seriousness, expectedness, and relatedness to the investigational therapy. If alternate 
procedures are followed for SAE review, the process for adequate medical monitoring will be 
defined in the AMC protocol and the Transfer of Regulatory Obligations (TORO) with the sponsor. 
AMC medical monitor review includes review of the CTEP-AERS report before CTEP submission 
for IDB review (if applicable), or review of the SAE report in the data entry system for trials not 
using CTEP-AERS for expedited reporting. The IND sponsor or its designee will issue the 
determination as to whether the AE requires IND safety reporting to FDA as a serious and 
unexpected suspected adverse drug reaction (SUSAR). For protocols not conducted under an IND, 

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in the event of disagreement between the reporting physician and the AMC medical monitor 
regarding the relationship of the AE to the investigational agent(s) (i.e., determination of whether 
the attribution is unrelated or unlikely, or possible, probable, or definite), the AMC medical 
monitor will provide the final determination of the relationship. IND safety reporting to FDA is 
performed by CTEP for trials conducted under a CTEP IND; IND safety reporting is performed 
by the sponsor or sponsor’s designee (AMC ODMC or other party defined in the study agreement 
or TORO) for IND studies sponsored by AMC investigators or industry sponsors. 
Expedited reporting to the Institutional Review Board (IRB) 
The requirements for IRB review will be identified in the protocol section on ethical and regulatory 
obligations. All AMC trials initiated before September 1, 2020 and all international sites for all 
AMC studies are subject to local IRB review; only U.S. sites are subject to the NCI requirement 
to use a single IRB for protocols initiated on or after September 1, 2020. For trials subject to local 
IRB review, the site principal investigator is responsible for ensuring that expedited AE reports 
for its trial participants and any unanticipated problems that affect the local institution only are 
submitted to the local IRB of the reporting institution, per the local IRB’s requirements for such 
reporting. For studies reviewed by the single IRB, the protocol chair will render a determination 
as to whether a SAE or other problem constitutes a trial-wide unanticipated problem that requires 
reporting to that RB, in accordance with its standards of procedure.  
To comply with investigator notification requirements for IND studies under 21 CFR 312.32 and 
312.55, IND safety reports from all trials the AMC conducts and reports from external sponsors 
investigating the same agents are made available to all investigators upon receipt from the sponsor 
or its designee, either via the password-protected section of the AMC Operations web site (AMC 
trials subject to local IRB review only) or the CTSU website (U.S. trials subject to single IRB 
review/CTEP IND agents). The site clinical investigator responsible for the applicable AMC 
protocol(s) is responsible for reviewing any IND safety reports received and documenting 
submission to the IRB of record (if required by local policy) within the timeline defined by the 
Clinical Trials Monitoring Branch (CTMB) audit guidelines. 
Procedures for monitoring trial progress and pharmacovigilance 
For trials using AdvantageEDC or Advantage eClinical for clinical data entry, the AMC ODMC 
provides on demand tabular listings of all reported AEs and SAEs on a participant level to the 
protocol chair and co-chair(s) for review via the password-protected section of the AMC 
Operations web site, www.AIDScancer.org. For trials using OPEN and Medidata Rave for clinical 
data collection, data listing will be made available using that system. Summary reports of AEs by 
frequency and relationship to the investigational agent(s) are provided to all AMC investigators 
and their staff It is the responsibility of each site to provide trial-specific AE listings to their 
respective IRB, if required by its policies. For blinded studies, the AE and SAE listings are 
reviewed and tabulated without treatment assignment. 
Accrual summaries for each AMC trial are updated nightly on the password-protected section of 
the AMC web site. The progress of each AMC trial is reviewed regularly by the protocol chair and 
also by the appropriate Scientific Working Group (SWG) during scheduled conference calls 
(monthly SWG calls and as required, protocol-specific monitoring conference calls). Summary 
accrual, summary AE, and individual SAE reports are provided to SWG leadership and protocol 
chairs to monitor participant safety during these monthly calls. 

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The AMC medical monitor reviews listings of all reported AEs on a quarterly basis for assuring 
compliance with the protocol requirements for AE reporting and the identification of any safety 
concerns (individual AE or increased frequency/severity of expected AEs) for the agents under 
investigation. Findings from these reviews are communicated to the protocol chairs and all AMC 
investigators, and posted to the AMC Operations web site. 
Data and Safety Monitoring Board Review (DSMB) review 
The AMC has formed an independent Data and Safety Monitoring Board (DSMB) for AMC trials 
and for the ANCHOR Study. As required by NCI policy, the AMC requires DSMB review for all 
phase III randomized trials. All other clinical trials that the AMC initiates will be reviewed by the 
AMC ODMC and AMC Statistical Center during protocol development to issue a recommendation 
as to whether the study requires DSMB oversight, which will require the approval of the AMC 
Executive Committee. This determination will be based on the phase of the study, experimental 
design, risk posed by the investigational approach, extent of data available on the safety of an 
investigational agent, risk posed by the natural course of the health condition under research, and 
the categories of vulnerable populations involved. The involvement of a DSMB in reviewing an 
AMC protocol will be identified in each clinical protocol as approved by CTEP and, as applicable, 
required by the IRB of record. 
Regarding the composition of the AMC DSMB, voting members usually include physicians, 
statisticians, an ethicist, and a patient advocate. All voting members have no other affiliation to 
the AMC and are appointed by the AMC Executive Committee with the approval of the OHAM 
Director. Nonvoting members are the AMC group statistician, the protocol statistician, an AMC 
ODMC staff member, two representatives (normally a clinician or statistician) from CTEP, and 
the grant program directors from the NCI Office of HIV and AIDS Malignancy (OHAM). 
The DSMB reviews all applicable AMC studies in accordance with the National Cancer Institute’s 
Policy for Data and Safety Monitoring. Confidential reports of all trials under review are prepared 
by the AMC group statistician with support from the AMC ODMC. A written report containing 
the current status of each trial monitored, and when appropriate, any toxicity and outcome data, 
are sent to DSMB members by the AMC ODMC within the timelines specified by the DSMB 
charter. This report addresses specific toxicity issues and any other concerns about the conduct of 
the trial, as defined by the protocol plan for DSMB review. The report may contain information 
for the DSMB to render determinations for participant safety, early trial termination, results 
reporting, or continuing accrual or follow-up. 
The results of each DSMB meeting are summarized in a formal report sent by the DSMB chair to 
the AMC group chair and AMC ODMC. The DSMB report contains recommendations on whether 
to close each study reviewed, whether to report the results, and whether to continue accrual or 
follow-up. A primary recommendation (e.g., continue with no change; recommended or required 
modification; stop) must be included in the document. The group chair or designee is then 
responsible for notifying the protocol chair and relevant SWG chair before the recommendations 
of the DSMB are carried out. In the unlikely event that the protocol chair does not concur with the 
DSMB, then the OHAM program directors and the NCI division director or designee must be 
informed of the reason for the disagreement. The protocol chair, relevant SWG chair, group chair, 
DSMB chair, and NCI division director or designee will be responsible for reaching a mutually 
acceptable decision about the study. CTEP approval of a protocol amendment will be required 
prior to any implementation of a change to the study. 

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Following a DSMB meeting, the DSMB’s recommendations are provided to all AMC investigators 
and staff. It is each site principal investigator’s responsibility for conveying this information to its 
local IRB as relevant for its protocol participation. For trials reviewed by a single IRB, the AMC 
ODMC will support notification to the IRB as required per its procedures. 
Cohort trial reviews not subject to DSMB review 
For phase I dose escalation trials, dose escalation (or dose de-escalation) is based on the rules in 
the protocol and the protocol chair, AMC medical monitor, and protocol statistician determine 
whether these criteria have been met based on a review of all safety data for the protocol-defined 
evaluation period. If applicable for phase II trials, stopping the trial for toxicity or efficacy, or 
suspending enrollment pending observation of responses in a multi-stage phase II trial, is based on 
meeting criteria stated in the protocol, and the protocol chair, AMC medical monitor, and protocol 
statistician determine whether these criteria have been met. 
Plans for Assuring Compliance with Requirements Regarding AE Reporting 
The protocol chair, AMC group chair, and the AMC ODMC share responsibility in assuring that 
participating investigators comply with applicable regulatory and protocol requirements for AE 
reporting. The AMC site principal investigator certifies compliance with NCI and FDA 
requirements for trial conduct by signing the site subaward agreement for the grant and the AMC 
Adherence Statement for site membership; clinical investigators also certify compliance in 
completing the protocol signature page for each protocol active at the site, and Form FDA-1572 
for CTEP investigator registration, and also for AMC IND studies sponsored by AMC 
investigators or industry sponsors. Protocol compliance with AE identification, assessment and 
reporting requirements is assessed by the AMC ODMC using several methods: 1) programmed 
system checks and messages to instruct the site to complete routine and/or expedited reporting 
when certain criteria are reported in the clinical data entry system; 2) programmed data reports 
provided to the protocol chairs that identify reports requiring expedited AE reporting; 3) remote 
review of data entry or data reports to ensure compliance with protocol and NCI AE reporting 
requirements; 4) AMC medical monitor review described in the section above; and, 5) routine site 
audits by reviewing the site’s source documentation. 
The clinical data entry systems used for AMC studies include the Oncology Patient Enrollment 
Network, OPEN for enrollment, and Medidata Rave for clinical data entry for enrolled 
participants; trials activated before September 1, 2020 or that involve only AMC international sites 
may be reported in AdvantageEDC/Advantage eClinical, a web-based data entry and enrollment 
system. These data entry systems are programmed to notify the site investigator, protocol chair, 
AMC medical monitor, and AMC ODMC via email in the event that a site reports an AE that 
meets expedited reporting criteria to NCI and/or FDA. Additional reporting conditions may be 
programmed depending on the sponsor reporting requirements of a given protocol (e.g., adverse 
events of special interest [AESI]). If the site does not follow with an expedited report, the AMC 
ODMC contacts sites to request compliance with reporting requirements. Additionally, the 
protocol chair, AMC ODMC, and the AMC medical monitor review reported AEs on a routine 
basis to identify AEs reported by sites that require expedited reporting. The protocol chair, AMC 
SWG chairs, AMC group chair, and IND sponsors have general oversight for assuring that routine 
and expedited adverse reporting requirements are met by the responsible parties. 
For studies monitored by CTEP using the Data Mapping Utility (DMU), cumulative protocol- and 
patient-specific data will be submitted weekly to CTEP electronically via the DMU. For trials 

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monitored by the NCI’s Clinical Data Update System (CDUS), AE information is transmitted 
electronically to NCI on a quarterly basis. For trials monitored by NCI’s Clinical Trials Monitoring 
Service (CTMS), AE information is transmitted electronically to NCI every two weeks. 
Plans for Assuring that any Action Resulting in a Temporary or Permanent Suspension of 
an NCI-Funded Clinical Trial is Reported to the NCI Grant Program Director Responsible 
for the Grant 
In the event that temporary or permanent suspension of a trial, or major modification to the 
protocol is under consideration, the protocol chair will convene the AMC ODMC, AMC Statistical 
Center, and SWG chair by conference call to discuss the options. Suspension actions will also be 
reviewed by the AMC Executive Committee for program oversight and direct communication of 
the action with the OHAM program directors. For phase III trials, closure decisions are typically 
rendered by the AMC DSMB; if the trial in question is under AMC DSMB oversight but rendered 
by the AMC investigators, the AMC DSMB will be notified of the suspension and the reason. For 
phase I and II trials, the protocol chair also has the option of asking the DSMB to review the study. 
The AMC ODMC will inform the CTEP Protocol Information Office (PIO), with copy to OHAM 
Directors, when studies are temporarily or permanently closed. In the event of major trial 
modification, CTEP must approve all protocol amendments prior to distributing to the AMC sites. 
Plans for Assuring Data Accuracy and Protocol Compliance 
All study data for AMC clinical trials are entered directly by AMC clinical site staff into the 
applicable clinical data entry system for the trial. During data entry, the system performs validation 
checks on many fields and performs consistency checks between select fields. Range checks are 
placed on each field to eliminate entry of out-of-range values. Edit check programs are run on the 
database on a set schedule to identify and resolve inconsistencies between forms or data collected 
at different points in time. Submitted data entry forms are reviewed for compliance with the 
protocol and data entry instructions according to the AMC ODMC’s standards for data quality 
processes. AMC ODMC staff routinely interacts with site staff to resolve any data submission 
problems. 
In accordance with NCI guidelines, the AMC ODMC conducts audits at the AMC sites to evaluate 
compliance with regulatory issues, and to review data for specific cases by checking source 
documents. These reports are sent to the site principal investigator and to the NCI. In the event 
that major violations are identified, sites are asked to provide a written corrective and preventative 
action plan to correct deficiencies. If needed, a repeat site audit is conducted. In the event that a 
site does not correct deficiencies in a pre-determined time frame, the AMC Executive Committee 
has the option to implement remedial action(s) for the site. Possible actions include, but are not 
limited to, suspending enrollment of new patients to AMC trials until deficiencies are corrected; 
recommending a decrease in funding to the site; and requiring specific training for site 
investigators or staff members.