LAST UPDATED
January 09, 2026
Clinicaltrials.gov ID
EudraCT ID
OVERVIEW
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
PROTOCOL SUMMARY
The primary objectives of Cohort 1 are to evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in human immunodeficiency virus - 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive adolescents. The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF (Part A), and to evaluate the safety and tolerability of E/C/F/TAF through Week 24 (Part B) in virologically suppressed HIV-1 infection children 6 to < 12 years weighing >= 25 kg. The primary objectives of Cohort 3 are to evaluate the PK of EVG and TAF and confirm the dose of the STR, and to evaluate the safety and tolerability of E/C/F/TAF low dose (LD) STR in virologically suppressed HIV-1 infected children ≥ 2 years of age and weighing ≥ 14 to < 25 kg.
View moreParticipation requirements
Age
2 years - 17 years
Sex
All
Healthy Volunteers
No
Age
2 years - 17 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Gender
N/A
Date
May 2013 - May 2020
Study Type
Interventional
Study Phase
Phase 2, Phase 3
Product
E/C/F/TAF, E/C/F/TAF (Low Dose)
Eligibility information
Inclusion criteria
- Cohort 1
- Age at baseline: 12 years to < 18 years old
- Weight at screening: ≥ 35 kg (77 lbs)
- Plasma HIV-1 ribonucleic acid (RNA) levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
- Screening genotype report shows sensitivity to EVG, emtricitabine (FTC) and tenofovir (TFV)
- No prior use of any approved or experimental anti-HIV-1 drug for any length of time
- Cohort 2
- Age at baseline: 6 years to < 12 years old
- Weight at screening: ≥ 25 kg (55 lbs)
- Plasma HIV-1 RNA of < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without documented history of resistance to any component of E/C/F/TAF STR.
- Cohort 3
- Age at baseline: ≥ 2 years old
- Weight at screening: ≥ 14 kg (31 lbs) to < 25 kg (55 lbs)
- Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days (6 months) prior to screening on a stable antiretroviral regimen, without prior history of resistance to any component of E/C/F/TAF STR
Exclusion criteria
- Hepatitis B or hepatitis C virus infection
- Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit.
- Individuals experiencing decompensated cirrhosis
- Pregnant or lactating females
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (16)
Miller's Children Hospital
Long Beach, California, United States, 90806
Children's Research Institute
Washington D.C., District of Columbia, United States, 20010
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Seattle Children's Hospital
Seattle, Washington, United States, 98105-0371
Perinatal HIV Research Unit Baragwanath Hospital
Johannesburg, South Africa, 1862
Empilweni Services and Research Unit (ESRU)
Johannesburg, South Africa, 2092
The HIV Netherlands Australia Thailand Research collaboration (HIV-NAT)
Bangkok, Thailand, 10330
Department of Pediatrics, Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand, 40002
University of Zimbabwe - Clinical Research Centre
Belgravia, Zimbabwe, 263
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