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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01818596

Public ClinicalTrials.gov record NCT01818596. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 5:47 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01818596
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
252 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 27, 2013 (Actual)
Primary completion
Jul 31, 2014 (Actual)
Completion
Jul 18, 2018 (Actual)
Last update posted
Mar 2, 2020

2013 – 2018

United States locations

U.S. sites
51
U.S. states
19
U.S. cities
43
Facility City State ZIP Site status
Maricopa Integrated Health System - McDowell Clinic Phoenix Arizona 85006 —
Pueblo Family Physicians Phoenix Arizona 85015 —
Health for Life Clinic PLLC Little Rock Arkansas 72207 —
Pacific Oaks Medical Group Beverly Hills California 90211 —
Kaiser Permanente Hayward California 94545 —
Long Beach Education and Research Consultants Long Beach California 90813 —
LA Gay & Lesbian Center - Jeffrey Goodman Special Care Clinic Los Angeles California 90028 —
Peter J Ruane, MD, Inc Los Angeles California 90036 —
Anthony Mills MD, Inc Los Angeles California 90069 —
Desert Medical Group Inc. dba Desert Oasis Healthcare Medical Group Palm Springs California 92262 —
Kaiser Permanente Medical Group Sacramento California 95825 —
Metropolis Medical San Francisco California 94109 —
Kaiser Permanente CTU San Francisco San Francisco California 94118 —
University of Colorado Aurora Colorado 80045 —
National Jewish Health Denver Colorado 80206 —
Dupont Circle Physician's Group Washington D.C. District of Columbia 20009 —
Gary J. Richmond, MD PA Fort Lauderdale Florida 33316 —
Midway Immunology and Research Center Ft. Pierce Florida 34982 —
Idocf/Valuhealthmd Orlando Florida 32806 —
University of South Florida Tampa Florida 33602 —
Triple O Research Institute, P.A. West Palm Beach Florida 33401 —
Rowan Tree Medical, P.A. Wilton Manors Florida 33305 —
Infectious Disease Specialists of Atlanta Decatur Georgia 30033 —
Mercer University Macon Georgia 31210 —
Indiana University School of Medicine Indianapolis Indiana 46202 —
Community Research Initiative of New England Boston Massachusetts 02111 —
The Research Institute Springfield Massachusetts 01105 —
Be Well Medical Center, P.C. Berkley Michigan 48210 —
Henry Ford Health System Detroit Michigan 48202 —
Hennepin County Medical Center Minneapolis Minnesota 55415 —
The Kansas City Care Clinic (KC Free Health Clinic) Kansas City Missouri 64111 —
Southampton Healthcare, Inc. St Louis Missouri 63139 —
Jersey Shore University Medical Center Neptune City New Jersey 07754 —
Saint Michael's Medical Center Newark New Jersey 07102 —
Southwest CARE Center Santa Fe New Mexico 87505 —
Albany Medical College Albany New York 12208 —
Upstate Infectious Diseases Associates Albany New York 12208 —
North Shore University Hospital/Division of Infectious Diseases Manhasset New York 11030 —
Aids Care Rochester New York 14607 —
Jacobi Medical Center The Bronx New York 10461 —
Montefiore Medical Center The Bronx New York 10467 —
University of Cincinnati Cincinnati Ohio 45267-0405 —
MetroHealth Medical Center Cleveland Ohio 44109 —
University of PA HIV Clinical Trials Unit Philadelphia Pennsylvania 19104 —
Thomas Jefferson University Philadelphia Pennsylvania 19107 —
St. Hope Foundation Bellaire Texas 77401 —
North Texas Infectious Diseases Consultants, PA Dallas Texas 75246 —
Garcias' Family Health Group Harlingen Texas 78550 —
Therapeutic Concepts, PA Houston Texas 77004 —
Gordon E. Crofoot MD, PA Houston Texas 77098 —
Peter Shalit, MD Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01818596, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 2, 2020 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01818596 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →