Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment

PHASE3CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

April 1, 2016

Primary Completion Date

September 14, 2017

Study Completion Date

September 29, 2017

Conditions
HIV-1 InfectionHCV Infection
Interventions
DRUG

E/C/F/TAF

150/150/200/10 mg fixed dose combination (FDC) tablet administered orally once daily

DRUG

F/R/TAF

200/25/25 mg FDC tablet administered orally once daily

DRUG

LDV/SOF

90/400 mg FDC tablet administered orally once daily

Trial Locations (43)

33136

University of Miami, Miami

Unknown

University of Alabama at Birmingham, Birmingham

Spectrum Medical Group, Phoenix

Mills Clinical Research, Los Angeles

Peter J Ruane MD Inc, Los Angeles

University of California Davis, Sacramento

University of California San Diego, San Diego

Kaiser Permanente, San Francisco

The George Washington University Medical Center, Washington D.C.

Whitman-Walker Health, Washington D.C.

Community AIDS Network, Clearwater

Gary Richmond, MD, PA, Inc., Fort Lauderdale

Therafirst Medical Center, Fort Lauderdale

Midway Immunology & Research Center, LLC, Ft. Pierce

AIDS Healthcare Foundation, Miami

AIDS Healthcare Foundation, Miami Beach

Orlando Immunology Center, Orlando

St. Josephs Comprehensive Research Institute, Tampa

Triple O Research Institute PA, West Palm Beach

Rowan Tree Medical PA, Wilton Manors

AIDS Research Consortium of Atlanta, Atlanta

Emory University, Atlanta

Chatham County Health Department, Savannah

The CORE Foundation, Chicago

Be Well Medical Center, Berkley

Kansas City Free Health Clinic, Kansas City

Saint Michael's Medical Center, Newark

Weill Cornell Medical College, New York

University of North Carolina at Chapel Hill, Chapel Hill

Duke University, Durham

East Carolina University, Greenville

Lehigh Valley Health Network, Network Office of Research and Innovation, Allentown

Philadelphia FIGHT, Philadelphia

University of Pennsylvania, Philadelphia

Central Texas Clinical Research, Austin

UT Southwestern Medical Center, Dallas

Gordon E. Crofoot MD PA, Houston

Therapeutics Concepts, PA, Houston

Clinical Alliance for Research & Education, Annandale

Peter Shalit MD, Seattle

Southern Cal, Spokane

Community Health Care, Tacoma

Clinical Research Puerto Rico Inc, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY