Demographic, Clinical, and Laboratory Characteristics and Outcomes of Patients Who Ever Received Etravirine and/or Darunavir - Multi-country Data Abstraction
Conditions: HIV/AIDS
Sponsor: Elizabeth Glaser Pediatric AIDS Foundation

 
 
 
 
 
 
New Horizons Advancing Pediatric HIV Care Collaborative 
 
Demographic, Clinical, and Laboratory Characteristics and Outcomes of 
Patients Who Ever Received Etravirine and/or Darunavir – Multi-
country Data Abstraction  
Version 2.0: 12 JUNE 2019 
 
 
 
Principal Investigators 
Dr. Natella Rakhmanina, Technical Lead, EGPAF, Washington DC, USA. nrakhmanina@pedaids.org    
Dr. Appolinaire Tiam, Director of Global Clinical Research, EGPAF, Washington DC, USA. atiam@pedaids.org 
Co-investigators 
Dr. Emma Sacks, Evaluation and Operational Research Lead, EGPAF, Washington, DC, USA. esacks@pedaids.org 
Dr. Rhoderick Machekano, Senior Biostatistician, EGPAF, Washington, DC, USA.  rmachekano@pedaids.org 
Katie Wallner, Technical Officer, EGPAF, Washington, DC, USA. kwallner@pedaids.org 
Dr. Lynne Mofenson, Senior Technical Advisor, EGPAF, Washington, DC, USA. lmofenson@pedaids.org 

Demographic, Clinical, and Laboratory Characteristics and Outcomes of Patients Who Ever Received 
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Contents 
I. 
Acronyms .............................................................................................................................................. 3 
II. 
Introduction .......................................................................................................................................... 4 
Background ........................................................................................................................................... 4 
Programmatic Response ....................................................................................................................... 4 
Objectives ................................................................................................................................................. 7 
Use of Results of this Evaluation ............................................................................................................... 7 
III. 
Procedures and Methods .................................................................................................................. 8 
Targeted Facilities ..................................................................................................................................... 8 
Sources of Data ......................................................................................................................................... 8 
Methods and Timeline .............................................................................................................................. 8 
Key Variables ............................................................................................................................................. 8 
Data Handling and Analysis ..................................................................................................................... 10 
Ethical Considerations ............................................................................................................................. 10 
Confidentiality/Privacy Protections ........................................................................................................ 12 
IV. 
References ...................................................................................................................................... 13 
 
 
 

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I. 
Acronyms 
 
ANC: 
 
Antenatal Care 
ART: 
 
Antiretroviral Therapy 
CDC: 
 
Centers for Disease Control and Prevention  
CIPHER  
Collaborative Initiative for Paediatric HIV Education and Research 
CHAI:  
 
Clinton Health Access Initiative 
CTC: 
 
Care and Treatment Clinic 
CTX: 
 
Cotrimoxazole  
 
DHMT:  
District Health Management Team 
DRV:  
 
Darunavir 
EGPAF:  
Elizabeth Glaser Pediatric AIDS Foundation 
EID: 
 
Early Infant Diagnosis 
EFV:  
 
Efavirenz  
ETR:  
 
Etravirine  
HCW:  
 
Health Care Workforce 
HIV:  
 
Human Immunodeficiency Virus 
 
IAS: 
 
International AIDS Society  
IRB: 
 
Institutional Review Board 
KG: 
 
Kilogram 
LPV: 
 
Lopinavir  
 
LPV/r:   
Lopinavir/ritonavir  
M&E:  
 
Monitoring and Evaluation 
MOH:   
Ministry of Health  
MSD:  
 
Medical Stores Department 
NRTI: 
 
Nucleoside Reverse Transcriptase Inhibitor 
NNRTI:  
Non-Nucleoside Reverse Transcriptase Inhibitor  
OGAC:  
Office of the Global AIDS Coordinator  
PFSCM:  
Partnership for Supply Chain Management  
PI: 
 
Protease Inhibitor  
RAL:  
 
Raltegravir  
RAMs:  
Resistance Associated Mutations 
R&R:  
 
Reporting and Requesting 
sdNVP:  
Single Dose Nevirapine 
SOP:  
 
Standard Operating Procedures 
TA: 
 
Technical Assistance 
TAMs:  
Thymidine Analogue Mutations 
TLE: 
 
Tenofovir/Lamivudine/Efavirenz 
TWG:  
 
Technical Working Group 
UNAIDS: 
Joint United Nations Programme on HIV/AIDS 
USAID:   
United States Agency for International Development  
WHO: 
 
World Health Organization  

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II. 
Introduction 
Background 
  
Rapid scale-up of antiretroviral therapy (ART) for HIV-infected children and adolescents is 
anticipated in the near future in response to UNAIDS 90-90-90 fast-track global HIV targets.  As 
more children and adolescents with HIV infection receive first-line ART and many subsequently 
face the challenge of the treatment failure, the need for second- and third-line ART will also 
increase.i,ii  Barriers to adherence, poor retention in care, gaps in available data and research, as 
well as limited second- and third-line options for children and adolescents highlight the need to 
address the issue of treatment failure in these vulnerable sub-groups.iii,iv,v,vi,vii,viii,ix  The 2015 World 
Health Organization (WHO) consolidated treatment guidelines recommend that national 
HIV/AIDS programs develop third-line ART guidance specifying regimens that include 
antiretroviral drugs (ARVs) unlikely to have cross-resistance with currently recommended first- 
and second-line ART regimens, such as integrase inhibitors, second-generation non-nucleoside 
reverse transcriptase inhibitors (NNRTI) and protease inhibitors (PI).x  Limited data from 
randomized clinical trials, mainly conducted in high and middle-income countries and among 
adult populations, demonstrate that etravirine (ETR), darunavir boosted with ritonavir (DRV/r), 
and raltegravir (RAL) used alone or in combination with other ARVs are efficacious when used in 
treatment-experienced patients with an optimized backbone.  For example, twice daily DRV/r 
plus an optimized nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) backbone was 
shown to be virologically and immunologically superior to the control regimen consisting of an 
investigator-selected control PI plus an optimized backbone in treatment-experienced adults 
with HIV as shown by a pooled subgroup analysis.xi In treatment-experienced adults with viremia 
and NNRTI and PI resistance, ETR paired with a background regimen of DRV/r and optimized 
backbone had improved durable rates of viral suppression and CD4 increase at 96 weeks 
compared to a similar regimen with ETV-placebo.xii Finally, in patients with multiple drug 
mutations with limited options for treatment, combination therapy including DRV/r, ETR, and 
RAL has been associated with high rates of virological suppression at 48-96 weeks. xiii,xiv  
Programmatic Response  
Janssen (the Pharmaceutical Companies of Johnson & Johnson), the Elizabeth Glaser Pediatric 
AIDS Foundation (EGPAF), the Partnership for Supply Chain Management (PFSCM), the 
Collaborative Initiative for Pediatric HIV Education and Research (CIPHER) of the International 
AIDS Society (IAS), Right to Care, and The Relevance Network have partnered to implement the 
New Horizons Advancing Pediatric HIV Care Collaborative (New Horizons Collaborative) to 
improve and scale-up pediatric HIV/AIDS care and treatment through increased awareness, 
research, health systems strengthening, and improved access to HIV/AIDS medicines.  

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There are various ways that Ministries of Health (MOH) can access DRV and/or ETR, such as 
through the Global Fund to Fight AIDS, Tuberculosis, and Malaria or other global donors, as well 
as direct purchase from the manufacturer. However, a primary source of DRV and ETR for 
pediatric populations in sub-Saharan Africa is through the New Horizons DRV/ETR Donation 
Program. Under the New Horizons Collaborative, a DRV/ETR Donation Program was launched in 
2014 to increase access to pediatric HIV medicines for children experiencing ART failure. Under 
this program, Janssen provides DRV (PREZISTA®) and/or ETR (INTELENCE®) free of charge to 
eligible national HIV/AIDS programs in sub-Saharan Africa, for use in children and adolescents up 
to 25 years of age. Upon turning 25 years (or before as required by the national HIV/AIDS 
program), patients using donated products will be transitioned into the countries’ HIV treatment 
programs for adults as designated by the national HIV program. Under this Donation Program, 
DRV in combination with ritonavir (RTV) may be used for either second- or third-line treatment 
after failure on lopinavir/ritonavir (LPV/r) and/or in individuals with virus that has multiple PI 
resistance mutations. Of note, the Donation Program does not endorse the use of DRV (along 
with RTV) as second- or third-line therapy for patients who have previously received only NNRTI-
based ART regimens (e.g., 2 NRTIs plus nevirapine or efavirenz).  
 
In order to be eligible for participation in the New Horizons Collaborative, countries must satisfy 
the following criteria: 
1. Applicant country must be located in sub-Saharan Africa or else considered to be a Least 
Developed Country as defined by the United Nations 
2. Medicine donation is legal in the applicant country 
3. Adult second - and third-line HIV treatment is part of the national HIV program (or will be  
put in place within 6 months of the applicant country’s acceptance into the donation 
program) 
4. The applicant country has national guidelines for second- and third-line pediatric HIV 
treatment 
5. DRV is approved for use in children in the applicant country  
6. ETR is approved for use in children in the applicant country 
7. There is demonstrated need for second – and third-line ARVs for children, adolescents, 
and young people 
8. The applicant country has necessary clinical expertise to identify children experiencing 
HIV treatment failure and manage children on second- and third-line treatment 
9. Other ARVs, including RTV, needed to create an active regimen with DRV and/or ETR, are 
available in country 
 
Countries currently participating in the New Horizons Collaborative include:  
- 
Cameroon 

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- 
Eswatini 
- 
Ethiopia 
- 
Kenya 
- 
Lesotho 
- 
Nigeria 
- 
Rwanda 
- 
Uganda 
- 
Zambia 
- 
Zimbabwe 
Any country that applies and is approved for receipt of donated product will become eligible for 
this study when they begin offering donated product to patients. 
Following acceptance of eligible countries into the New Horizons Donation Program, Janssen and 
PFSCM have worked with the Ministries of Health (MOH) to forecast and order needed product. 
Orders of DRV and ETR are shipped to a central warehouse in South Africa, managed by Imperial 
Health Sciences. Following receipt and processing into South Africa, individual country orders are 
then sent to the respective MOH.  
EGPAF has been provided with funding by Johnson & Johnson Services to manage the country 
application process and convene the third-party review committee for country selection. EGPAF 
is also responsible for provision of technical assistance (TA) to national HIV/AIDS programs 
engaged in the New Horizons Collaborative. In 2014, EGPAF volunteered to conduct a collection 
of baseline demographic and clinical data for patients receiving DRV and/or ETR through in New 
Horizons Collaborative countries.  The evaluation included 48 patients (45.8% female; median 
age=15 years) from nine clinical sites in Zambia, Swaziland, Kenya and Lesotho.vi Most children 
(87.5%) had received ≥ 2 prior ART regimens; 81.2% had received lopinavir/ritonavir-based ART 
prior to switch.  ARV drug resistance was common; of 47 patients with genotype results, 87.2% 
had ≥1 NRTI-resistance mutation (RM), predominantly M184V; 65.9% had ≥1 non-NRTI-RM, 
including 57.4% with ≥1 ETR-RM; 63.8% had ≥ 3 protease inhibitor RM, including 42.6% with ≥ 1 
DRV-RM. For new ART regimens, DRV and RAL were most frequently prescribed (83.3%; n=40 on 
DRV and raltegravir, each). Eighteen patients (37.5%) were initiated on the NRTI-sparing ART.vi 
These data reflect baseline information on children receiving DRV and/or ETR through New 
Horizons but did not capture new ART regimen treatment response. Hence, EGPAF is proposing 
to conduct a similar data collection from children and adolescents receiving DRV and/or ETR. For 
each patient, we will collect demographic, clinical and laboratory data (1) as recorded at the time 
of initiation on DRV and/or ETR, and (2) updated information approximately every six months, 
through 2021. New patients will be added to the dataset who have been enrolled since the 
previous data collection point. 

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Prior to the inception of the New Horizons Collaborative, no multi-country data were collected 
regarding the demographic or clinical characteristics of the target patient population (i.e., 
children, adolescents, and young people < 25 years in need of second- or third-line HIV/AIDS 
treatment). Therefore, the current activity proposes to collect cross-sectional demographic and 
clinical data at baseline and every six months for patients receiving DRV and/or ETR across 
participating New Horizons countries. This activity will comprise data abstraction of a key 
demographic, clinical, laboratory and case history indicators and outcomes on each patient who 
ever received DRV and/or ETR. 
Objectives 
The objectives of this data collection activity are to: 
a) Describe the baseline demographics, clinical and laboratory profile of patients who ever 
received DRV and/or ETR, at the time of initiation on DRV and/or ETR,  
b) Describe the clinical and laboratory profile of patients who ever received DRV and/or ETR 
every 6 months from the first data collection point through 2021,    
c) Describe dynamics in HIV drug resistance mutations among patients who fail treatment 
on new regimens, including DRV and/or ETR. 
d) Describe demographics, clinical and laboratory profile of young adults who transition out 
of the donation program after the age of 25 years at 12 months after their transition. 
Use of Results of this Evaluation 
The de-identified data from each participating country will be analyzed and reported to relevant 
MOH. These overall demographic and clinical findings will be used to describe the children and 
adolescents who have received DRV and/or ETR up through each time point of data collection. 
Data from this evaluation will be used as resource when countries review their national 
guidelines for second- and third-line ART. 
The findings will be presented at regional and international scientific meetings or conferences.  
Data summarized across New Horizons countries will be shared with programmatic stakeholders 
and potential New Horizons partners. These stakeholders include the Centers for Disease Control 
and Prevention (CDC), the United States Agency for International Development (USAID), the 
United States Office of the Global AIDS Coordinator (OGAC), IAS CIPHER, the Clinton Health 
Access Initiative (CHAI), PFSCM, various industry partners such as Janssen and Merck, and others.  

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III. 
Procedures and Methods 
Targeted Facilities 
Data collection will occur in the existing clinical programs that are currently managing patients 
on ART regimens, which include at least one product (i.e., DRV and/or ETR).  
Sources of Data 
Data will be abstracted from individual patient files/cards stored at the health facility. Only those 
patient files which represent recipients of DRV and/or ETR will be accessed for the purposes of 
this activity.  All data collection tools and processes will be approved by the in-country IRB. Each 
patient will be assigned a unique Study identification (ID) number and data collection forms will 
be linked to the patient using this unique identifier only.  The data abstraction team will maintain 
a master document (“link log”) that allows linking of files of participants to the unique ID. Access 
to this document will be limited to members of the abstracting team and the evaluation team.  
Methods and Timeline 
The current data collection activity is intended to describe the demographic, clinical  and 
laboratory characteristics of patients at the point of initiation on DRV and/or ETR and b) the most 
recently recorded data at the time of most recent data collection point (every six months). 
Patients will be stratified by the duration of time on ETR and/or DRV. 
Members of the abstraction team will visit each participating facility which is handling patients 
who ever used DRV and/or ETR on a convenient and mutually agreeable day.  Because the 
volumes of patients on DRV and/or ETR are anticipated to be low, data collection activities at 
each facility are not anticipated to take more than a few hours on a single day. Data abstraction 
from each patient is expected to be repeated approximately every six months from the last data 
collection point. The last data collection activity is anticipated to occur in December 2021. 
 
Key Variables 
 
Table 1: Key variables and data source. 
Objectives 
Variables 
Data sources 
Comment 
a) Describe the demographics, 
clinical and laboratory profiles 
of patients who ever received 
DRV and/or ETR, at the time 
of initiation on DRV and/or 
ETR.  
 
- 
Age 
- 
Gender 
- 
Weight 
- 
Height (when 
available) 
- 
Clinical 
card 
- 
ART 
register 
- 
Lab register 
Data collection team should 
use ART and Lab registers, 
among others, to complement 
data not found in the clinical 
cards 

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- 
Viral load at the time 
of DRV and/or ETR 
initiation 
- 
Baseline ARV drug 
resistance mutations 
b) Describe clinical and 
laboratory profile of patients 
who ever received DRV 
and/or ETR every 6 months 
from the first data collection 
point through 2021.    
 
- 
Weight 
- 
Height 
- 
Most recent viral 
load 
- 
Any new genotypic 
resistance assay 
results  
- 
Clinical 
records 
- 
ART 
registers 
- 
Lab 
registers 
Data collection team should 
abstract data from ART clinical 
file and ART and lab registers, 
among other registers.   
These 
data 
will 
be 
disaggregated by time duration 
from last visit as 6, 12, 18, 24, 30 
and 36 months. 
c) Describe dynamics in HIV drug 
resistance mutations among 
patients who fail treatment 
on new regimens, including 
DRV and/or ETR. 
 
- 
Weight 
- 
Height 
- 
Viral load 
- 
Duration receiving 
DRV/ETR 
- 
Genotypic resistance 
test results 
- 
Lab based suggested 
regimen by clinical 
virologist 
- 
Clinical 
records 
- 
Lab 
registers 
These data will be abstracted 
from Laboratory form/register, 
among other registers. 
d) Describe demographics, 
clinical and laboratory profile 
of young adults who transition 
out of the donation program 
after the age of 25 years at 12 
months after their transition. 
- 
Weight 
- 
Height 
- 
Most recent viral 
load 
- 
Any new genotypic 
resistance assay 
results 
- 
Clinical 
records 
- 
ART 
registers 
- 
Lab 
registers 
Data collection team should 
abstract data from ART clinical 
file and ART and lab registers, 
among other registers.   
 
 
 
 
Table 2. Schedule of Evaluation data extraction from each clinical file 
Study Activity 
Baseline 
6 months 
12 months 
18 months 
24 months 
30 months 
36 months 
Demographics 
X 
 
 
 
 
 
 
Review Patient Clinical file 
X 
X 
X 
X 
X 
X 
X 
Record of co-morbidities, 
such as TB, etc. 
X 
X 
X 
X 
X 
X 
X 
Weight 
X 
X 
X 
X 
X 
X 
X 

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Height (if available) 
X 
X 
X 
X 
X 
X 
X 
Results of Viral Load 
X1 
X 
X 
X 
X 
X 
X 
Recorded Clinical diagnosis 
of Treatment Failure 
X 
X 
X 
X 
X 
X 
X 
Genotypic Resistance 
mutation 
X 
X 
X 
X 
X 
X 
X 
Records of pregnancy 
X 
X 
X 
X 
X 
X 
X 
 
Data Handling and Analysis 
EGPAF will fund the data collection, data entry, analyses and reporting activities. Data will be 
abstracted from patient files, ART register or laboratory registers at participating facilities by an 
EGPAF staff member specifically trained in the objectives and methods of the current assessment 
(the “abstraction team”). All evaluation team members will be trained in patient confidentiality 
and human subject protection. Data abstraction will occur in a private location of the health 
facility to minimize any risk of unauthorized viewing of medical records. 
Routinely collected patient-level data will be abstracted from patient files and recorded into a 
password protected database. Each patient will be assigned a unique study ID and data collection 
will be linked to the patient using this unique ID only.  A master document, “link log” that permits 
linking of the patient’s name to the unique identification number will be maintained in password 
protected files by the abstracting team, with access to this document limited to members of the 
abstracting team and the evaluation team only.  Baseline demographic, clinical and laboratory 
data will be summarized using frequencies and percentages for categorical variables and mean 
(SD) or median (IQR) for continuous variables depending on their distributions. 
Clinical and laboratory follow-up data will be summarized using appropriate descriptive statistics 
stratified by duration on DRV/ETR. In addition, patient records will be stratified by duration of 
time on DRV/ETR, and retention on DRV/ETR regimen will be described. 
Other analyses may also be conducted using the de-identified data. 
Ethical Considerations 
Institutional Review Board and Informed Consent 
This protocol will be reviewed by an Institutional Review Board (IRB) in the US and an 
ethical review committee in each of the project countries. The local in-country ethics 
committees will also receive and approve country-specific details about the evaluation. 

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This protocol will be conducted with human subject oversight locally in countries 
participating in the New Horizons Collaborative from the local Institutional Review 
Boards (IRBs) and in the United States from Advarra IRB (IORG0000635) (Formerly called 
“Chesapeake IRB”). We are requesting a waiver of consent to abstract data from routine 
clinic registers, forms, and charts for several reasons, all of which conform with United 
States (US) Federal regulations OHRP-45CFR46.116, DHHS- 45CFR46.117(c), and HIPAA-
CFR 164.512(i)(2)(ii). According to US federal regulations, a waiver of consent is 
acceptable if the following criteria are met: 
a) The research involves no more than minimal risk to the participants, and 
involves no procedures for which written consent is normally required 
outside of the evaluation/research context. 
b) The waiver will not adversely affect the rights and welfare of the participants. 
c) The research could not practicably be carried out without the waiver. 
d) Whenever appropriate, the participants are provided with additional 
pertinent information after participation. 
This evaluation and all the procedures involved with collecting and analyzing routinely 
program data impose minimal risk to participants because it does not involve direct 
interaction between the program evaluation staff and patients on DRV and/or ETV. Study 
numbers will be used and protocols put in place to protect patient identifiers from 
improper use and disclosure and reduce accidental disclosures. Patient identifiers will be 
redacted or destroyed at the completion of the study. 
A waiver of consent would not adversely affect the rights and welfare of participants 
because no identifiable information will be recorded in the electronic database.  Patient 
identifiers will only be recorded on an evaluation enrollment log during the data 
abstraction phase to link patient-level data across routine clinic registers, and clinical 
cards. When the data abstraction and data cleaning phases have been completed and 
patient identifiers are no longer required for research purposes, the enrollment log will 
be shredded. Because age and sex are important variables potentially associated with 
some of the outcomes to be measured, information on these two variables will be 
collected. All evaluation staff will be required to sign a confidentiality agreement 
prohibiting disclosure of any individual-level information including HIV status. The 
evaluation databases will be password-protected, and all electronic communications 
involving program evaluation data will be encrypted. 
Risks 
This study involves minimal risk to participants.  All data collected are being abstracted 
from routinely-collected information in existing medical charts and no interactions 

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between patients and study staff are required. Key risks involve breaches of 
confidentiality but steps will be taken to ensure confidentiality and protect privacy.  
Confidentiality/Privacy Protections 
All evaluation staff members who collect identifiable patient level data or analyze collected data 
will complete training in human subjects’ protections process prior to starting the study.  
Standard operating procedures for data security and confidentiality will be implemented and 
staff will be trained on this protocol. In addition, during site visits, facility staff or MOH 
representatives may escort data collectors through the facilities, as appropriate.  Any breaches 
of confidentiality will be immediately reported to the EGPAF regulatory officer and appropriate 
ethical committees, as required. 

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IV. 
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