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Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

NCT01818596 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2020-03-02

Study results available
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Summary

The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.

Conditions

  • HIV
  • HIV Infections

Interventions

DRUG

E/C/F/TAF

E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-27
Primary Completion
2014-07-31
Completion
2018-07-18
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Dominican Republic
  • France
  • Mexico
  • Netherlands
  • Spain
  • Thailand
  • 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 NCT01818596 on ClinicalTrials.gov