Overview

This trial is active, not recruiting.

Condition hiv-1 infection
Treatments bic, ftc/taf, dtg, bic placebo, dtg placebo, bic/f/taf
Phase phase 2
Sponsor Gilead Sciences
Start date March 2015
End date October 2015
Trial size 98 participants
Trial identifier NCT02397694, GS-US-141-1475

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants will receive BIC + FTC/TAF FDC + DTG placebo for 48 weeks. Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
bic GS-9883
75 mg tablet administered orally once daily
ftc/taf
200/25 mg FDC tablet administered orally once daily
dtg placebo
Tablet administered orally once daily
bic/f/taf
50/200/25 mg FDC tablet administered orally once daily
(Active Comparator)
Participants will receive DTG + FTC/TAF FDC + BIC placebo for 48 weeks. Following Week 48, participants will continue to take their blinded treatment and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive BIC/F/TAF until it becomes commercially available, or until Gilead Sciences elects to terminate the development of BIC/F/TAF.
ftc/taf
200/25 mg FDC tablet administered orally once daily
dtg Tivicay®
50 mg tablet administered orally once daily
bic placebo
Tablet administered orally once daily
bic/f/taf
50/200/25 mg FDC tablet administered orally once daily

Primary Outcomes

Measure
Percentage of participants with HIV-1 RNA < 50 copies/mL as determined by the FDA-defined snapshot algorithm.
time frame: Week 24

Secondary Outcomes

Measure
Percentage of participants with HIV-1 RNA < 50 copies/mL as determined by the FDA-defined snapshot algorithm.
time frame: Week 12
Percentage of participants with HIV-1 RNA < 50 copies/mL as determined by the FDA-defined snapshot algorithm.
time frame: Week 48
The change from baseline in log10 HIV-1 RNA and in CD4+ cell count
time frame: Weeks 12, 24 and 48
The incidence of treatment-emergent adverse events (AEs) and treatment-emergent laboratory abnormalities.
time frame: Up to 1 year
Maximum observed plasma concentration (Cmax) of BIC, FTC, and TAF
time frame: Week 4 or 8
Time to maximum observed plasma concentration (Tmax) of BIC, FTC, and TAF
time frame: Week 4 or 8
Observed drug concentration at the end of the dosing interval (Ctau) for BIC, FTC, and TAF
time frame: Week 4 or 8
Area under the concentration-time curve over the dosing interval (AUCtau) for BIC, FTC, and TAF
time frame: Week 4 or 8
Estimate of the terminal elimination half-life (t1/2) of BIC, FTC, and TAF
time frame: Week 4 or 8
Trough plasma concentrations for BIC, FTC, and TAF
time frame: Weeks 4, 8, 12 and 24

Eligibility Criteria

Male or female participants at least 18 years old.

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 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 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

Additional Information

Official title A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9883 + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.