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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

NCT02603107 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 578

Last updated 2020-12-29

Study results available
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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.

Conditions

  • HIV-1 Infection

Interventions

DRUG

RTV

100 mg capsule coadministered orally with ATV or DRV once daily with food

DRUG

ATV

300 mg capsule administered orally once daily with food

DRUG

DRV

800 mg tablet administered orally once daily with food

DRUG

COBI

150 mg tablet coadministered orally with ATV or DRV once daily with food

DRUG

ATV/co

300/150 mg FDC tablet administered orally once daily with food

DRUG

DRV/co

800/150 mg FDC tablet administered orally once daily with food

DRUG

FTC/TDF

200/300 mg FDC tablet administered orally once daily without regard to food

DRUG

ABC/3TC

600/300 mg tablet administered orally once daily with or without regard to food

DRUG

B/F/TAF

50/200/25 mg FDC tablet administered orally once daily without regard to food

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-20
Primary Completion
2017-05-15
Completion
2019-12-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Dominican Republic
  • France
  • Germany
  • Italy
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02603107 on ClinicalTrials.gov