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Study to Evaluate the Safety and Efficacy of E/C/F/TAF Versus E/C/F/TDF in HIV-1 Positive, Antiretroviral Treatment-Naive Adults

NCT01797445 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 872

Last updated 2020-03-02

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.

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

E/C/F/TDF Placebo

Tablet administered orally once daily

DRUG

E/C/F/TAF Placebo

Tablet 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
2013-03-12
Primary Completion
2014-09-19
Completion
2018-10-03
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Dominican Republic
  • France
  • Italy
  • Mexico
  • Netherlands
  • Portugal
  • Puerto Rico
  • Sweden
  • United Kingdom

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 NCT01797445 on ClinicalTrials.gov