Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Gilead Sciences98 enrolled

Overview

This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

HIV-1 Infection

Interventions

BICDRUG

75 mg tablet administered orally once daily

F/TAFDRUG

200/25 mg FDC tablet administered orally once daily

DTGDRUG

50 mg tablet administered orally once daily

BIC Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent) * Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening * Screening genotype report provided by Gilead Sciences must show sensitivity to tenofovir (TFV) and emtricitabine (FTC) * Adequate renal function as measured by estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft-Gault formula * CD4+ cell count ≥ 200 cells/µL at screening Key Exclusion Criteria: * A new AIDS-defining condition diagnosed within the 30 days prior to screening as defined in the study protocol * Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post exposure prophylaxis (PEP) * Chronic hepatitis B virus (HBV) infection * Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but have a documented negative HCV RNA, are eligible) * Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline * Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (21)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Los Angeles, California, United States

Outcomes

Primary Outcomes

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant'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

Secondary Outcomes

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 12 was analyzed using the snapshot algorithm, which defines a participant'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 12

Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48

The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant'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

The Change From Baseline in log10 HIV-1 RNA at Week 12

Time frame: Baseline; Week 12

The Change From Baseline in log10 HIV-1 RNA at Week 24

Time frame: Baseline; Week 24

The Change From Baseline in log10 HIV-1 RNA at Week 48

Time frame: Baseline; Week 48

Data from ClinicalTrials.gov

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