Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV

Phase 2

Recruiting

• Conditions: Acquired Immune Deficiency Syndrome (AIDS); HIV Infections
• Interventions: Drug: ATV; Drug: Third Unboosted Drug; Drug: DRV; Drug: LPV/r; Drug: Cobicistat TOS; Drug: Cobicistat; Drug: F/TAF; Drug: BR; Drug: F/TAF TOS

• Registration Number: NCT02016924
• Lead Sponsor: Gilead Sciences

Brief Summary

The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to \< 18 years) with HIV.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-20
• Study Start: 2014-01-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-06
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• HIV-1 infected, virologically suppressed males and females age ≥ 4 weeks to < 18 years (according to requirements of enrolling Cohort).

• Body weight at screening ≥ 25 to < 40 kg (Cohort 2); ≥ 14 to < 25 kg (Cohort 3); ≥ 3 to < 25 kg (Cohort 4); ≥ 3 to < 14 kg (Cohort 5).

• Stable antiretroviral (ARV) regimen for a minimum of 3 months prior to the screening visit.

  • Participants enrolled prior to implementation of Amendment 7: 2 nucleoside reverse transcriptase inhibitors (NRTIs) and ritonavir-boosted atazanavir (ATV/r) once daily or ritonavir-boosted darunavir (DRV/r) once daily or twice daily.

  • Participants enrolled after the implementation of Amendment 9:

    • Cohorts 2, 3 and 4 (Group 1): 2 NRTIs plus a third agent per local prescribing guidelines. Participants will switch from their current third agent to ATV or darunavir (DRV) at Day 1. Participants taking DRV must be on once-daily dosing or must switch to once daily at or prior to Day 1. Cohort 4 (Group 1), participants may also switch their current third agent to lopinavir boosted with ritonavir (LPV/r) at Day 1. Participants will switch their NRTI backbone to emtricitabine/tenofovir alafenamide (coformulated; Descovy®) (F/TAF).
    • Cohort 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3): 2 NRTIs plus a third agent per local prescribing guidelines or treatment naive. Participants on treatment will switch from their current third agent to ATV or LPV/r (Cohort 4 (Groups 2 to 4)), or to a third unboosted agent (Cohort 5 (Groups 1 to 3)). Participants will switch their NRTI backbone to F/TAF.

• Participants undergoing dose modifications to their ARV regimen for growth or switching medication formulations are considered to be on a stable ARV regimen.

• Documented plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) for ≥ 3 months preceding the screening visit:

  • Participants enrolled after the implementation of Amendment 9:

    • For Cohorts 2, 3, and 4 (Group 1), virologically suppressed ≥ 3 months preceding the screening visit: HIV-1 RNA < 50 copies/mL on a stable regimen (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).
    • For Cohorts 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3), on an ARV regimen irrespective of plasma HIV-1 RNA copies or treatment naive; a participant is considered treatment naive, if ARVs were given for prevention of mother-to-child transmission but not for HIV treatment.

  • For virologically suppressed participants, unconfirmed virologic elevations of HIV-1 RNA ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on 2 consecutive HIV-1 RNA tests.

• Adequate renal function: Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73m2 using the Schwartz formula. If ≥ 1 year old, eGFR greater than or equal to the minimum normal value for age using the Schwartz formula. If < 1 year old as follows:

  • Age minimum value for eGFR (mL/min/1.73 m2) > 28 days to ≤ 95 days is 30, ≥ 96 days to ≤ 6 months is 39, > 6 to < 12 months is 49.

• Participants must not have documented or suspected resistance to applicable study drugs including emtricitabine (Emtriva®) (FTC), TFV, ATV, DRV, or LPV. Participants < 14 kg (Cohorts 4 (Groups 2 to 4) and 5 (Groups 1 to 3)) with M184V/I AND HIV-1 RNA < 50 copies/mL will be allowed.

• Positive confirmatory HIV test (confirmatory nucleic acid-based testing if < 18 months of age).

• Cohort 4 (Groups 2 to 4) and Cohort 5 (Groups 1 to 3): Last dose of nevirapine or efavirenz, if applicable, ≥ 14 days prior to enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria do apply.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 4 (Group 4)	Cobicistat TOS	Participants age ≥ 4 weeks old weighing 3 to \< 6 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 15/1.88 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 3	ATV	Participants age ≥ 2 years old will receive cobicistat 90 mg and F/TAF 120/15 mg with either ATV or DRV.
Cohort 1: Part A and Part B	ATV	Participants ages 12 to \<18 years old will receive cobicistat 150 mg with either ATV or DRV plus background regimen (BR). The BR may contain additional antiretroviral agents except for the following disallowed agents: saquinavir, indinavir, nelfinavir, double protease inhibitor (PI) regimens, raltegravir, elvitegravir, efavirenz, nevirapine, delavirdine, maraviroc, etravirine, rilpivirine, dolutegravir, and investigational antiretroviral agents.
Cohort 2	DRV	Participants aged 6 to \<12 years old and ≥25 to \<40kg will receive cobicistat 150 mg and F/TAF 200/25 mg with either ATV or DRV.
Cohort 2	F/TAF	Participants aged 6 to \<12 years old and ≥25 to \<40kg will receive cobicistat 150 mg and F/TAF 200/25 mg with either ATV or DRV.
Cohort 3	F/TAF	Participants age ≥ 2 years old will receive cobicistat 90 mg and F/TAF 120/15 mg with either ATV or DRV.
Cohort 4 (Group 1)	ATV	Participants age ≥ 4 weeks old weighing 14 to \< 25 kg will receive cobicistat tablet for oral suspension (TOS) 90 mg, once daily and F/TAF TOS 120/15 mg, once daily with either ATV or DRV or lopinavir boosted by ritonavir (LPV/r). Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, minimum age and weight for DRV is ≥ 3 years and ≥ 15 kg; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 4 (Group 2)	ATV	Participants age ≥ 4 weeks old weighing 10 to \< 14 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 60/7.5 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 1: Part A and Part B	DRV	Participants ages 12 to \<18 years old will receive cobicistat 150 mg with either ATV or DRV plus background regimen (BR). The BR may contain additional antiretroviral agents except for the following disallowed agents: saquinavir, indinavir, nelfinavir, double protease inhibitor (PI) regimens, raltegravir, elvitegravir, efavirenz, nevirapine, delavirdine, maraviroc, etravirine, rilpivirine, dolutegravir, and investigational antiretroviral agents.
Cohort 1: Part A and Part B	BR	Participants ages 12 to \<18 years old will receive cobicistat 150 mg with either ATV or DRV plus background regimen (BR). The BR may contain additional antiretroviral agents except for the following disallowed agents: saquinavir, indinavir, nelfinavir, double protease inhibitor (PI) regimens, raltegravir, elvitegravir, efavirenz, nevirapine, delavirdine, maraviroc, etravirine, rilpivirine, dolutegravir, and investigational antiretroviral agents.
Cohort 2	ATV	Participants aged 6 to \<12 years old and ≥25 to \<40kg will receive cobicistat 150 mg and F/TAF 200/25 mg with either ATV or DRV.
Cohort 2	Cobicistat	Participants aged 6 to \<12 years old and ≥25 to \<40kg will receive cobicistat 150 mg and F/TAF 200/25 mg with either ATV or DRV.
Cohort 4 (Group 4)	LPV/r	Participants age ≥ 4 weeks old weighing 3 to \< 6 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 15/1.88 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 3	DRV	Participants age ≥ 2 years old will receive cobicistat 90 mg and F/TAF 120/15 mg with either ATV or DRV.
Cohort 4 (Group 1)	LPV/r	Participants age ≥ 4 weeks old weighing 14 to \< 25 kg will receive cobicistat tablet for oral suspension (TOS) 90 mg, once daily and F/TAF TOS 120/15 mg, once daily with either ATV or DRV or lopinavir boosted by ritonavir (LPV/r). Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, minimum age and weight for DRV is ≥ 3 years and ≥ 15 kg; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 4 (Group 2)	Cobicistat TOS	Participants age ≥ 4 weeks old weighing 10 to \< 14 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 60/7.5 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 4 (Group 3)	LPV/r	Participants age ≥ 4 weeks old weighing 6 to \< 10 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 30/3.75 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 4 (Group 3)	F/TAF TOS	Participants age ≥ 4 weeks old weighing 6 to \< 10 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 30/3.75 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 4 (Group 4)	ATV	Participants age ≥ 4 weeks old weighing 3 to \< 6 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 15/1.88 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 4 (Group 1)	DRV	Participants age ≥ 4 weeks old weighing 14 to \< 25 kg will receive cobicistat tablet for oral suspension (TOS) 90 mg, once daily and F/TAF TOS 120/15 mg, once daily with either ATV or DRV or lopinavir boosted by ritonavir (LPV/r). Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, minimum age and weight for DRV is ≥ 3 years and ≥ 15 kg; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 4 (Group 3)	ATV	Participants age ≥ 4 weeks old weighing 6 to \< 10 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 30/3.75 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 5 (Group 3)	Third Unboosted Drug	Participants ages ≥ 4 weeks old weighing ≥ 3 to \< 6 kg will receive F/TAF TOS 15/1.88 mg, once daily with the third unboosted drug.
Cohort 4 (Group 1)	F/TAF TOS	Participants age ≥ 4 weeks old weighing 14 to \< 25 kg will receive cobicistat tablet for oral suspension (TOS) 90 mg, once daily and F/TAF TOS 120/15 mg, once daily with either ATV or DRV or lopinavir boosted by ritonavir (LPV/r). Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, minimum age and weight for DRV is ≥ 3 years and ≥ 15 kg; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 4 (Group 2)	LPV/r	Participants age ≥ 4 weeks old weighing 10 to \< 14 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 60/7.5 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 4 (Group 3)	Cobicistat TOS	Participants age ≥ 4 weeks old weighing 6 to \< 10 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 30/3.75 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 4 (Group 1)	Cobicistat TOS	Participants age ≥ 4 weeks old weighing 14 to \< 25 kg will receive cobicistat tablet for oral suspension (TOS) 90 mg, once daily and F/TAF TOS 120/15 mg, once daily with either ATV or DRV or lopinavir boosted by ritonavir (LPV/r). Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, minimum age and weight for DRV is ≥ 3 years and ≥ 15 kg; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 4 (Group 2)	F/TAF TOS	Participants age ≥ 4 weeks old weighing 10 to \< 14 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 60/7.5 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 5 (Group 1)	Third Unboosted Drug	Participants ages ≥ 4 weeks old weighing ≥ 10 to \< 14 kg will receive F/TAF TOS 60/7.5 mg, once daily with the third unboosted drug.
Cohort 5 (Group 3)	F/TAF TOS	Participants ages ≥ 4 weeks old weighing ≥ 3 to \< 6 kg will receive F/TAF TOS 15/1.88 mg, once daily with the third unboosted drug.
Cohort 5 (Group 1)	F/TAF TOS	Participants ages ≥ 4 weeks old weighing ≥ 10 to \< 14 kg will receive F/TAF TOS 60/7.5 mg, once daily with the third unboosted drug.
Cohort 5 (Group 2)	Third Unboosted Drug	Participants ages ≥ 4 weeks old weighing ≥ 6 to \< 10 kg will receive F/TAF TOS 30/3.75 mg, once daily with the third unboosted drug.
Cohort 5 (Group 2)	F/TAF TOS	Participants ages ≥ 4 weeks old weighing ≥ 6 to \< 10 kg will receive F/TAF TOS 30/3.75 mg, once daily with the third unboosted drug.
Cohort 4 (Group 4)	F/TAF TOS	Participants age ≥ 4 weeks old weighing 3 to \< 6 kg will receive cobicistat TOS 30 mg (twice daily) and F/TAF TOS 15/1.88 mg, once daily with either ATV or LPV/r. Minimum age and weight for ATV is ≥ 3 months and ≥ 5 kg, respectively; participants receiving LPV/r will not receive cobicistat TOS.
Cohort 1: Part A and Part B	Cobicistat	Participants ages 12 to \<18 years old will receive cobicistat 150 mg with either ATV or DRV plus background regimen (BR). The BR may contain additional antiretroviral agents except for the following disallowed agents: saquinavir, indinavir, nelfinavir, double protease inhibitor (PI) regimens, raltegravir, elvitegravir, efavirenz, nevirapine, delavirdine, maraviroc, etravirine, rilpivirine, dolutegravir, and investigational antiretroviral agents.
Cohort 3	Cobicistat	Participants age ≥ 2 years old will receive cobicistat 90 mg and F/TAF 120/15 mg with either ATV or DRV.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) Through Week 24	First dose date up to Week 24 plus 30 days (Cumulative data through Week 24)
Pharmacokinetic (PK) Parameter: AUCtau of ATV, DRV, TAF, and TFV	Predose on Day 1, and postdose up to Week 48	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).; AUCtau for ATV (Cohorts 1 Part A, 2, 3, and 4 \[Groups 2 to 4\]); DRV (Cohorts 1 Part A, 2, and 3); TAF (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 \[Groups 1 to 3\] taking F/TAF); and TFV (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 \[Groups 1 to 3\] taking F/TAF) will be reported.
Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities Through Week 24	First dose date up to Week 24 plus 30 days (Cumulative data through Week 24)

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in CD4+ Cell Counts (cells/μL) at Week 48	Baseline, Week 48
PK Parameter: Clast of TAF	Predose on Day 1, and postdose up to Week 48	Clast is defined as the the last observed quantifiable concentration of the drug in plasma.; Clast for TAF (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF) will be reported.
PK Parameter: Vz/F of COBI, TAF, FTC and TFV	Predose on Day 1, and postdose up to Week 48	Vz/F is defined as the apparent volume of distribution of the drug.; Vz/F for COBI (Except Cohort 5); for TAF (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF); for FTC and TFV (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF) will be reported.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	First dose date up to Week 48 plus 30 days (Cumulative data through Week 48)
PK Parameter: Ctau of ATV, DRV, COBI, FTC and TFV	Predose on Day 1, and postdose up to Week 48	Ctau is defined as the observed drug concentration at the end of the dosing interval.; Ctau for ATV (cohorts 1, 2, 3, and 4 (Groups 2 to 4)), DRV (cohorts 1, 2, and 3), COBI (except Cohort 5), FTC and TFV (cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF) will be reported.
PK Parameter: Cmax of ATV, DRV, COBI, TAF, FTC and TFV	Predose on Day 1, and postdose up to Week 48	Cmax is defined as the maximum observed concentration of drug.; Cmax for ATV (Cohorts 1, 2, 3, and 4 \[Groups 2 to 4\]) and DRV (Cohorts 1, 2, and 3); for COBI (except Cohort 5); for TAF, FTC and TFV (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF) will be reported.
Percentage of Participants with HIV-1 RNA < 50 Copies/mL at Week 24 and as Defined by the US FDA-defined Snapshot Algorithm	Week 24
Percentage of Participants with HIV-1 RNA < 50 Copies/mL at Week 48 and as Defined by the US FDA-defined Snapshot Algorithm	Week 48
Acceptability of COBI and F/TAF as Measured by Palatability Score	Week 48
PK Parameter: CL/F of ATV, DRV, COBI, TAF, FTC and TFV	Predose on Day 1, and postdose up to Week 48	CL/F is defined as the apparent oral clearance following administration of the drug.; CL/F for ATV (Cohorts 1, 2, 3, and 4 \[Groups 2 to 4\]) and DRV (Cohorts 1, 2, and 3); for COBI (except Cohort 5); for TAF, FTC and TFV (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF) will be reported.
Change from Baseline in CD4+ Cell Counts (cells/μL) at Week 24	Baseline, Week 24
Change from Baseline in Percentage of CD4+ Cells at Week 24	Baseline, Week 24
PK Parameter: AUCtau of COBI and FTC	Predose on Day 1, and postdose up to Week 48	AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).; AUCtau for COBI (Except Cohort 5) and FTC will be reported.
PK Parameter: AUClast of TAF, FTC and TFV	Predose on Day 1, and postdose up to Week 48	AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.; AUClast for TAF (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF); for FTC and TFV (Cohorts 2, 3, 4 \[Groups 1 to 4\] and 5 taking F/TAF) will be reported.
Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values	First dose date up to Week 48 plus 30 days (Cumulative data through Week 48)
Change from Baseline in Percentage of CD4+ Cells at Week 48	Baseline, Week 48

Trial Locations

Locations (34)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Srinagarind Hospital; 🇹🇭 Khon Kaen, Thailand

Queen Savang Vadhana Memorial Hospital; 🇹🇭 Sriracha, Thailand

MU-JHU Research Collaboration/MU-JHU Care Ltd; 🇺🇬 Kampala, Uganda

SICRA-TASO Mulago National Referral Hospital; 🇺🇬 Kampala, Uganda

AMBSO Masaka Clinical Research Site; 🇺🇬 Masaka, Uganda

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom

University of Zimbabwe Clinical Research Centre; 🇿🇼 Harare, Zimbabwe

HIV-NAT; 🇹🇭 Bangkok, Thailand

Rahima Clinical Trials, a Division of Wits Health Consortium (Pty) Ltd; 🇿🇦 Johannesburg, South Africa

Pediatric Infectious Disease Associates; 🇺🇸 Long Beach, California, United States

Jeffrey Goodman Special Care Clinic; 🇺🇸 Los Angeles, California, United States

Peter Morton Medical Building; 🇺🇸 Los Angeles, California, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

The George Washington University; 🇺🇸 Washington, District of Columbia, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States

Emory-Children's Center- Ponce Family and Youth Clinic; 🇺🇸 Atlanta, Georgia, United States

Boston University Medical Center; 🇺🇸 Boston, Massachusetts, United States

New York University School of Medicine; 🇺🇸 New York, New York, United States

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States

University of Texas Health Science Center of Houston; 🇺🇸 Houston, Texas, United States

Hospital General de Agudos Cosme Argerich; 🇦🇷 Buenos Aires, Argentina

Fundacion Huesped; 🇦🇷 Buenos Aires, Argentina

Helios Salud; 🇦🇷 Buenos Aires, Argentina

Hospital Jose Maria Ramos Mejia; 🇦🇷 Buenos Aires, Argentina

Hopital del Nino; 🇵🇦 Panama City, Panama

University of the Free State; 🇿🇦 Bloemfontein, South Africa

University of Stellenbosch; 🇿🇦 Cape Town, South Africa

Dr. J. Fourie Medical Practice; 🇿🇦 Dundee, South Africa

King Edward VIII Hospital; 🇿🇦 Durban, South Africa

Be Part Yoluntu Centre; 🇿🇦 Paarl, South Africa

The Aurum Institute: Pretoria Clinical Research Centre; 🇿🇦 Pretoria, South Africa

Perinatal HIV Research Unit; 🇿🇦 Soweto, South Africa