A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain

PHASE4CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

July 1, 2020

Primary Completion Date

August 7, 2023

Study Completion Date

August 30, 2023

Conditions
HIV-1
Interventions
DRUG

D/C/F/TAF FDC

A FDC tablet containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg will be administered once daily.

DRUG

TAF/FTC FDC

TAF/FTC ARV regimen will be administered once daily.

DRUG

INI Based Regimen

The integrase (INI) inhibitors (for example, bictegravir, dolutegravir, elvitegravir/cobicistat, and raltegravir) will be administered in combination with TAF/FTC, as appropriate. Regimen may consist of a single tablet regimen or a combination of two separate pills.

Trial Locations (34)

10001

AIDS Healthcare Foundation-Research Center, New York

10029

Mount Sinai Hospital-New York, New York

10467

Montefiore Medical Center, The Bronx

19104

University of Pennsylvania, Philadelphia

19107

Philadelphia Fight, Philadelphia

20852

Kaiser Permanente, Rockville

24501

Infectious Disease Associates of Central Virginia, Lynchburg

29203

Palmetto Health - USC, Columbia

30309

Atlanta ID Group, Atlanta

30912

Medical College of Georgia, Augusta

31201

The Corporation of Mercer University, Macon

31401

Chatham County Health Department, Savannah

33136

University of Miami, Miami

33407

Triple O Research Institute, West Palm Beach

34982

Midway Immunology and Research Center, Ft. Pierce

35222

University of Alabama at Birmingham, Birmingham

39216

University of Mississippi Medical Center, Jackson

48072

Be Well Medical Center, PC, Berkley

48202

Henry Ford Health System, Detroit

53203

Vivent Health, Milwaukee

60612

The Ruth M. Rothstein CORE Center, Chicago

63110

Washington University School Of Medicine, St Louis

68106

University of Nebraska, Omaha

70806

Care South Clinic, Baton Rouge

75208

AIDS Arms Incorporated Trinity Health and Wellness Center, Dallas

75246

North Texas Infectious Diseases Consultants, Dallas

75605

DCOL Center for Clinical Research, Longview

76104

Texas Centers for Infectious Disease Associates, Fort Worth

77004

Therapeutic Concepts - Donald R Watkins Foundation, Houston

90211

AIDS Health Foundation-Westside HCC, Beverly Hills

90813

Long Beach Education & Research Consultants, Long Beach

93301

The Office of Franco Felizarta, MD, Bakersfield

02129

Community Research Initiative, Boston

07102

Saint Michaels Medical Center - Infectious Disease, Newark

All Listed Sponsors
lead

Janssen Scientific Affairs, LLC

INDUSTRY

NCT04442737 - A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain | Biotech Hunter | Biotech Hunter