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Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants

NCT01815736 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1443

Last updated 2021-04-13

Study results available
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Summary

The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA \< 50 copies/mL at Week 48.

Conditions

  • HIV
  • HIV Infections

Interventions

DRUG

E/C/F/TAF

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

DRUG

E/C/F/TDF

150/150/200/300 mg FDC tablet administered orally once daily

DRUG

EFV/FTC/TDF

600/200/300 mg FDC tablet administered orally once daily

DRUG

RTV

100 mg tablet administered orally once daily

DRUG

ATV

300 mg capsule administered orally once daily

DRUG

FTC/TDF

200/300 mg tablet administered orally once daily

DRUG

COBI

150 mg tablet administered orally once daily

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
2013-03-27
Primary Completion
2015-03-16
Completion
2020-04-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Denmark
  • Dominican Republic
  • France
  • Germany
  • Italy
  • Mexico
  • Netherlands
  • Portugal
  • Puerto Rico
  • Spain
  • Sweden
  • Switzerland
  • Thailand
  • United Kingdom

Study Locations

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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 NCT01815736 on ClinicalTrials.gov