Phase I/II Dose-Finding, Safety, Tolerance, and Pharmacokinetics Study of a Raltegravir-Containing Antiretroviral Therapy (ART) Regimen in HIV-Infected and TB Co-Infected Infants and Children
Phase: PHASE1
Conditions: HIV Infections, Tuberculosis
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Letter of Amendment #1 for: 
 
IMPAACT P1101 
 
Phase I/II Dose-finding, Safety, Tolerance and Pharmacokinetics Study of a Raltegravir-
Containing Antiretroviral Therapy (ART) Regimen in HIV-infected and TB Co-infected 
Infants and Children 
 
A Multicenter, International Trial of the 
International Maternal Pediatric Adolescent AIDS 
Clinical Trials Network (IMPAACT) 
 
Protocol: Version 3.0, dated 24 April 2017 
 
Letter of Amendment Date: 15 March 2018 
 
 
 
NCT 01751568 
 

Letter of Amendment #1       
Page 1 of 3 
15 March 2018 
IMPAACT P1101 Protocol Version 3.0 
Letter of Amendment #1 for: 
 
IMPAACT P1101 
Phase I/II Dose-finding, Safety, Tolerance and Pharmacokinetics Study of a Raltegravir-
Containing Antiretroviral Therapy (ART) Regimen in HIV-infected and TB Co-infected 
Infants and Children 
 
Version 3.0, dated 24 April 2017 
 
 DAIDS Document ID # 11831 
IND # 77,787 Held By NIAID 
 
Letter of Amendment Date: 15 March 2018 
 
 
Information/Instructions to Study Sites from the Division of AIDS 
 
The information contained in this Letter of Amendment (LoA) impacts the IMPAACT P1101 study, 
including the sample informed consent form (ICF), and must be submitted to site Institutional Review 
Boards and/or Ethics Committees (IRBs/ECs) as soon as possible for their review and approval. Approval 
must also be obtained from site regulatory entities if applicable per the policies and procedures of the 
regulatory entities. All IRB/EC and regulatory entity requirements must be followed. 
 
Upon receiving IRB/EC approval and any other applicable regulatory entity approvals, all sites should 
immediately begin implementing this LoA and using the updated ICFs. After all required approvals are 
obtained, the updated ICFs should be used for all new participants. In addition, all previously enrolled 
participants must reconsent to ongoing study participation using the updated site-specific ICF. Re-
consenting should take place at each enrolled participant’s next study visit after all required approvals are 
obtained.  
 
Sites are required to submit a LoA registration packet to the DAIDS Protocol Registration Office (DAIDS 
PRO) at the Regulatory Support Center (RSC). Sites will receive a registration notification for the LoA 
after the DAIDS PRO verifies that all required registration documents have been received and are 
complete. Sites should not await this notification before implementing this LoA.  
 
Please file this LoA, all associated IRB/EC and regulatory entity correspondence, and all correspondence 
with the DAIDS PRO in your essential documents files for P1101. If the P1101 protocol is amended in 
the future, the contents of this LoA will be incorporated into the next version of the protocol. 
 
 

Letter of Amendment #1       
Page 2 of 3 
15 March 2018 
IMPAACT P1101 Protocol Version 3.0 
IMPAACT P1101 
Phase I/II Dose-finding, Safety, Tolerance and Pharmacokinetics Study of a Raltegravir-Containing 
Antiretroviral Therapy (ART) Regimen in HIV-infected and TB Co-infected Infants and Children 
 
Version 3.0, dated 24 April 2017 
(DAIDS Document ID 11831) 
 
Version 3.0, Letter of Amendment #1 
Dated 15 March 2018 
 
Letter of Amendment Signature Page 
 
I will conduct this study in accordance with the provisions of this protocol and all applicable protocol-
related documents. I agree to conduct this study in compliance with United States (US) Health and 
Human Service regulations (45 CFR 46); applicable US Food and Drug Administration regulations; 
standards of the International Conference on Harmonization Guideline for Good Clinical Practice (E6); 
Institutional Review Board/Ethics Committee determinations; all applicable in-country, state, and local 
laws and regulations; and other applicable requirements (e.g., US National Institutes of Health, Division 
of AIDS) and institutional policies. 
 
 
 
 
 
 
 
Signature of Investigator of Record 
 
Date 
 
 
 
 
 
Name of Investigator of Record 
 
 
(printed) 
 

Letter of Amendment #1       
Page 3 of 3 
15 March 2018 
IMPAACT P1101 Protocol Version 3.0 
Summary of Modifications and Rationale 
 
This LoA updates language regarding regulatory entities that may review study records. Per ICH GCP E6 
4.8.10(n) and DAIDS requirements, it is mandatory that all DAIDS-sponsored and/or supported trials 
include language that informs participants that other US, local, and international regulatory entities may 
also review study records. Protocol Section 10.2 and the sample ICF have been updated accordingly. 
 
Implementation 
 
The modifications included in this LoA are listed below in order of appearance in the protocol. Additions to 
the text are indicated in bold; deletions are indicated by strikethrough.  
 
In Section 10.2, Participant Confidentiality: 
 
All laboratory specimens, evaluation forms, reports, and other records will be identified only by a coded 
number to maintain participant confidentiality. All records will be kept in a secured area. All computer 
entry and networking programs will be done with coded numbers only. Clinical information will not be 
released without written permission of the participant, except as necessary for monitoring by the study 
staff, study monitors, FDA, the OHRP, NIH, the local IRB/EC, or Merck & Co., Inc, and other US, 
local, and international regulatory entities. 
 
In Appendix VI, Sample Informed Consent Form for Study Participation, WHAT ABOUT 
CONFIDENTIALITY?, second paragraph: 
 
Your child’s records may be reviewed by the U.S. Food and Drug Administration (FDA), the Office of 
Human Research Protections (OHRP), (insert name of site) IRB/EC, National Institutes of Health (NIH), 
study staff, study monitors, and Merck & Co., Inc. (the drug company supporting this study), and other 
US, local, and international regulatory entities.