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

Gilead Sciences60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV

Interventions

E/C/F/TAFDRUG

150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (7)

Unnamed facility

Tampa, Florida, United States

Unnamed facility

Detroit, Michigan, United States

Unnamed facility

New York, New York, United States

Unnamed facility

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Serious Adverse Events

The percentage of participants experiencing any treatment-emergent serious adverse event was summarized.

Time frame: Up to Week 48

Incidence of Treatment-Emergent Adverse Events

The percentage of participants experiencing any treatment-emergent adverse event was summarized.

Time frame: Up to Week 48

Secondary Outcomes

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.

Time frame: 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.

Time frame: Week 48

Change From Baseline in CD4 Cell Count at Week 24

Time frame: Baseline; Week 24

Change From Baseline in CD4 Cell Count at Week 48

Time frame: Baseline; Week 48

Change From Baseline in CD4 Percentage at Week 24

Data from ClinicalTrials.gov

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