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Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

NCT02607956 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 657

Last updated 2022-03-07

Study results available
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Summary

This primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults.

Conditions

  • HIV-1 Infection

Interventions

DRUG

DTG

50 mg tablets administered orally, once daily

DRUG

F/TAF

200/25 mg tablets administered orally, once daily

DRUG

B/F/TAF

50/200/25 milligrams (mg) FDC tablets administered orally, once daily

DRUG

DTG Placebo

Tablets administered orally, once daily

DRUG

F/TAF Placebo

Tablets administered orally, once daily

DRUG

B/F/TAF Placebo

Tablets administered orally, once daily

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-11
Primary Completion
2017-05-12
Completion
2021-07-05
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 NCT02607956 on ClinicalTrials.gov