NCT01815736|CompletedPhase 3ResultsDMCFDA Drug

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

A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects

Gilead Sciences ClinicalTrials.gov

Compare

2 other identifiers

GS-US-292-01092012-005114-20

Study Type

interventional

Target

1,443

Locations

19 countries

Sites

164

Timeline

RegisteredMar 2013

StartedMar 2013

CompletionApr 2020

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,443

participants targeted

Target at P75+ for phase_3 hiv

Timeline

Completed

Started Mar 2013

Longer than P75 for phase_3 hiv

Geographic Reach

19 countries

164 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 years study duration

First Submitted

Initial submission to the registry

March 19, 2013

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed

6 days until next milestone

Study Start

First participant enrolled

March 27, 2013

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2015

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

April 14, 2016

Completed

4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed

Last Updated

April 13, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

March 19, 2013

Results QC Date

March 15, 2016

Last Update Submit

March 22, 2021

Conditions

HIV HIV Infections

Keywords

HIVHIV 1 InfectedVirologically-Suppressed

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Week 48

Secondary Outcomes (9)

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Baseline; Week 48
Percent Change From Baseline in Spine BMD at Week 48
Baseline; Week 48
Change From Baseline in Serum Creatinine at Week 48
Baseline; Week 48
Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48
Baseline; Week 48
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Week 96
+4 more secondary outcomes

Study Arms (2)

E/C/F/TAF

EXPERIMENTAL

Randomized Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment, all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF.

Drug: E/C/F/TAF

Stay on Baseline Treatment Regimen (SBR)

ACTIVE COMPARATOR

Randomized Phase: Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF; efavirenz (EFV)/FTC/TDF; ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks. Extension Phase: After completing 96 weeks of randomized treatment (SBR), all participants will be given the opportunity to receive open-label E/C/F/TAF until it becomes commercially available, or until Gilead elects to terminate the development of E/C/F/TAF.

Drug: E/C/F/TDFDrug: EFV/FTC/TDFDrug: RTVDrug: ATVDrug: FTC/TDFDrug: COBI

Interventions

E/C/F/TAFDRUG

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

Also known as: EVG/COBI/FTC/TAF; Genvoya®

E/C/F/TAF

E/C/F/TDFDRUG

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

Also known as: Stribild®