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Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

NCT01475838 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 438

Last updated 2016-06-08

Study results available
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Summary

This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA \< 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

Conditions

  • Acquired Immunodeficiency Syndrome
  • HIV Infections

Interventions

DRUG

PI

PI administered according to prescribing information; allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)

DRUG

RTV

RTV administered according to prescribing information FTC/TDF administered according to prescribing information

DRUG

FTC/TDF

FTC/TDF (200/300 mg) administered according to prescribing information

DRUG

Stribild

Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food

Sponsors & Collaborators

Principal Investigators

  • Thai Nguyen-Cleary · 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
2011-11-30
Primary Completion
2013-11-30
Completion
2014-12-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Portugal
  • Puerto Rico
  • Spain
  • Switzerland
  • 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 NCT01475838 on ClinicalTrials.gov