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Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed

NCT03110380 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 567

Last updated 2022-01-11

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.

Conditions

Interventions

DRUG

B/F/TAF

50/200/25 mg FDC tablet(s) administered orally once daily

DRUG

F/TAF

200/25 mg FDC tablet(s) administered orally once daily

DRUG

DTG

50 mg tablet(s) administered orally once daily

DRUG

DTG Placebo

Tablet(s) administered orally once daily

DRUG

F/TAF Placebo

Tablet(s) administered orally once daily

DRUG

B/F/TAF Placebo

Tablet(s) 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
2017-06-12
Primary Completion
2018-12-04
Completion
2021-02-10
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Canada
  • France
  • Germany
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases
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 NCT03110380 on ClinicalTrials.gov