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Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women

NCT02652624 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 472

Last updated 2020-03-04

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 elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically suppressed HIV-1 infected women.

Conditions

  • HIV-1 Infection

Interventions

DRUG

E/C/F/TAF

150/150/200/10 mg FDC tablet administered orally once daily with food

DRUG

E/C/F/TDF

150/150/200/300 mg FDC administered orally once daily with food

DRUG

ATV

ATV 300 mg capsules administered orally once daily with food

DRUG

RTV

RTV 100 mg tablets administered orally once daily with food

DRUG

FTC/TDF

200/300 mg tablet administered orally once daily with 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
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-19
Primary Completion
2017-10-09
Completion
2018-11-26
FDA Drug
Yes

Countries

  • United States
  • Dominican Republic
  • Puerto Rico
  • Russia
  • Thailand
  • Uganda

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 NCT02652624 on ClinicalTrials.gov