NCT02603107|CompletedPhase 3ResultsDMCFDA Drug

Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

Gilead Sciences ClinicalTrials.gov

Compare

2 other identifiers

GS-US-380-18782015-004011-20

Study Type

interventional

Target

578

Locations

11 countries

Sites

119

Timeline

RegisteredNov 2015

StartedNov 2015

CompletionDec 2019

Brief Summary

The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adults who are virologically suppressed.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

578

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Nov 2015

Typical duration for phase_3

Geographic Reach

11 countries

119 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.1 years study duration

First Submitted

Initial submission to the registry

November 10, 2015

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed

9 days until next milestone

Study Start

First participant enrolled

November 20, 2015

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

June 6, 2018

Completed

1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed

Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

1.5 years

First QC Date

November 10, 2015

Results QC Date

May 3, 2018

Last Update Submit

December 7, 2020

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
The percentage of participants with 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.
Week 48

Secondary Outcomes (2)

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm
Week 48
Change From Baseline in CD4 Cell Count at Week 48
Baseline to Week 48

Study Arms (2)

B/F/TAF

EXPERIMENTAL

Randomized Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for at least 48 weeks, without regard to food. Extension Phase: After Week 48, participants in countries where B/F/TAF is not available will be given the option to receive B/F/TAF for up to 96 additional weeks or until the product becomes accessible to participants through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first.

Drug: B/F/TAF

Stay on Baseline Regimen (SBR)

EXPERIMENTAL

Randomized Phase: Participants remained on current antiretroviral (ARV) regimen consisting of ritonavir (RTV)-boosted or cobicistat (COBI)-boosted atazanavir (ATV) or darunavir (DRV), plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) for at least 48 weeks with food. Extension Phase: After Week 48, participants in countries where B/F/TAF is not available will be given the option to receive B/F/TAF for up to 96 additional weeks or until the product becomes accessible to participants through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever occurs first.

Drug: RTVDrug: ATVDrug: DRVDrug: COBIDrug: ATV/coDrug: DRV/coDrug: FTC/TDFDrug: ABC/3TCDrug: B/F/TAF