Purpose

There will be 3 cohorts in this study. 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) single tablet regimen (STR) (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 (Part B) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents. The primary objectives of Cohort 2 are to evaluate the PK of EVG and TAF in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg administered E/C/F/TAF STR (Part A) and to evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 in virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg (Part B). 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.

Conditions

Eligibility

Eligible Ages
Over 2 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Cohort 1
  • 12 years to < 18 years of age at baseline
  • Weight greater than or equal to 35 kg (77 lbs)
  • Plasma HIV-1 RNA levels of ≥ 1,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
  • Screening genotype report shows sensitivity to EVG, FTC and tenofovir (TFV)
  • No prior use of any approved or experimental anti-HIV-1 drug for any length of time
  • Cohort 2
  • 6 years to < 12 years of age at baseline
  • Weight greater than or equal to 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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 (12 to < 18 years of age)
Participants within the ages of 12 and <18 years old will receive E/C/F/TAF STR once daily with food.
  • Drug: E/C/F/TAF
    E/C/F/TAF tablets contain 150 mg of elvitegravir (EVG), 150 mg of cobicistat (COBI), 200 mg of emtricitabine (FTC), and 10 mg of tenofovir alafenamide (TAF; as 11.2 mg of TAF fumarate)
Experimental
Cohort 2 (6 to < 12 years of age)
Participants within the ages of 6 and <12 years old and weighing ≥ 25 kg will receive E/C/F/TAF STR once daily with food.
  • Drug: E/C/F/TAF
    E/C/F/TAF tablets contain 150 mg of elvitegravir (EVG), 150 mg of cobicistat (COBI), 200 mg of emtricitabine (FTC), and 10 mg of tenofovir alafenamide (TAF; as 11.2 mg of TAF fumarate)
Experimental
Cohort 3 (≥ 2 years of age)
Participants ≥ 2 years of age and weighing ≥ 14 to < 25 kg will receive E/C/F/TAF STR once daily with food.
  • Drug: E/C/F/TAF (Low Dose)
    90/90/120/6 mg STR administered orally

Recruiting Locations

Children's National and nearby locations

Children's Research Institute
Washington, District of Columbia 20010
Contact:
202-476-2083

More Details

NCT ID
NCT01854775
Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Study Team
GS-US-292-0106@gilead.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.