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Study to Evaluate 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

NCT01854775

CompletedPhase 2, Phase 3

Sponsor: Gilead Sciences

Conditions: Acquired Immune Deficiency Syndrome (AIDS), HIV Infections

Interventions: E/C/F/TAF, E/C/F/TAF (Low Dose)

Countries: United States, South Africa, Thailand, Uganda, Zimbabwe

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.

Eligibility overview

Sex: ALL

Age: 2 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key 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

Key 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 (16)

Long Beach, California, United States
Washington D.C., District of Columbia, United States
Atlanta, Georgia, United States
Memphis, Tennessee, United States
Seattle, Washington, United States
Cape Town, South Africa
Cape Town, South Africa
Cape Town, South Africa
Johannesburg, South Africa
Johannesburg, South Africa
Johannesburg, South Africa
Bangkok, Thailand
Chon Buri, Thailand
Khon Kaen, Thailand
Kampala, Uganda
Belgravia, Zimbabwe