Clinical trial NCT02276612: Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents
Official title: A Phase 2/3, Open-Label Study to Evaluate the Safety and Efficacy of E/C/F/TAF in HIV-1 Infected Virologically Suppressed Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HIV
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2014-10-28
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-infected virologically suppressed adolescents 12 to \< 18 years of age.


Eligibility criteria: Key Inclusion Criteria:

* Currently on a stable antiretroviral regimen for ≥ 6 consecutive months
* Weight ≥ 35 kg (77 lbs.)
* Plasma HIV-1 RNA levels \< 50 copies/mL for ≥ 6 months
* CD4+ cell count \> 100 cells/μL
* No resistance to elvitegravir (EVG), emtricitabine (FTC), lamivudine (3TC) or tenofovir (TFV)
* Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
* No evidence of current hepatitis B virus (HBV) infection
* No evidence of current hepatitis C virus (HCV) infection

Note: participants from Gilead Study GS-US-162-0112 were allowed to roll over into this Study GS-US-292-1515 even if they were 18 years or older at the time of screening.

Key Exclusion Criteria:

* A new AIDS-defining condition diagnosed within the 30 days prior to Screening
* Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of screening
* Pregnant or lactating subjects

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

Primary outcomes:
measure: Incidence of Treatment-Emergent Serious Adverse Events
timeFrame: Up to Week 48
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to Week 48
Secondary outcomes:
measure: Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis)
timeFrame: Week 24
measure: Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis)
timeFrame: Week 48
measure: Change From Baseline in CD4 Cell Count at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in CD4 Cell Count at Week 48
timeFrame: Baseline; Week 48
measure: Change From Baseline in CD4 Percentage at Week 24
timeFrame: Baseline; Week 24
measure: Change From Baseline in CD4 Percentage at Week 48
timeFrame: Baseline; Week 48
Other outcomes:
Locations:
city: Tampa
country: United States
state: Florida
city: Detroit
country: United States
state: Michigan
city: New York
country: United States
state: New York
city: Memphis
country: United States
state: Tennessee
city: Cape Town
country: South Africa
city: Johannesburg
country: South Africa
city: Soweto
country: South Africa
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: