Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Adolescents

Study Overview
=================
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.

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

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Drug: E/C/F/TAF


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E/C/F/TAF<br>Treatment-experienced participants will receive open-label E/C/F/TAF for up to 48 weeks. After completion of 48 weeks of treatment, all eligible participants will be given the option to participate in an open-label extension phase to receive E/C/F/TAF until a) the participant turns 18 years old and E/C/F/TAF is commercially available for use in adults in the country the participant is enrolled, or b) E/C/F/TAF becomes commercially available for use in the participant's current age group in the country the participant is enrolled, or c) E/C/F/TAF becomes accessible to participants through an access program, or d) Gilead Sciences elects to terminate development of E/C/F/TAF in the applicable country. | Drug: E/C/F/TAF<br>* 150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food<br>* Other names: Genvoya®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Serious Adverse Events | The percentage of participants experiencing any treatment-emergent serious adverse event was summarized. | Up to Week 48 | 
| Incidence of Treatment-Emergent Adverse Events | The percentage of participants experiencing any treatment-emergent adverse event was summarized. | Up to Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis) | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 24 | 
| Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis) | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 48 | 
| Change From Baseline in CD4 Cell Count at Week 24 |  | Baseline; Week 24 | 
| Change From Baseline in CD4 Cell Count at Week 48 |  | Baseline; Week 48 | 
| Change From Baseline in CD4 Percentage at Week 24 |  | Baseline; Week 24 | 
| Change From Baseline in CD4 Percentage at Week 48 |  | Baseline; Week 48 |