Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection

PHASE4CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

October 22, 2018

Primary Completion Date

July 30, 2020

Study Completion Date

February 28, 2021

Conditions
Hepatitis CHIV-1-infectionLiver Diseases
Interventions
DRUG

Sofosbuvir/Velpatasvir (SOF/VEL)

400/100 mg fixed-dose combination (FDC) tablet administered orally once daily with or without food.

OTHER

Minimal Monitoring (MINMON) Strategy

"MINMON Strategy:~1. No pre-treatment HCV genotyping~2. Entire treatment course (84) tablets of SOF/VEL administered to participants at study entry~3. No scheduled on-treatment laboratory monitoring or clinic visits~4. Remote contact with participants at week 4 and week 22"

Trial Locations (38)

2193

University of the Witwatersrand Helen Joseph (WITS HJH) CRS (11101), Johannesburg

7505

Family Clinical Research Unit (FAM-CUR) CRS (8950), Cape Town

10010

Weill Cornell Chelsea CRS (7804), New York

10032

Columbia Physicians and Surgeons CRS (30329), New York

10065

Weill Cornell Upton CRS (7803), New York

10330

Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (31802), Bangkok

14642

University of Rochester Adult HIV Therapeutic Strategies Network CRS (31787), Rochester

15213

Pittsburgh CRS (1001), Pittsburgh

19104

Hosp. of the Univ. of Pennsylvania CRS (6201), Philadelphia

20009

Whitman Walker Health CRS (31791), Washington D.C.

21045

Instituto de Pesquisa Clinica Evandro Chagas (12101), Rio de Janeiro

21205

Johns Hopkins University CRS (201), Baltimore

27401

Greensboro CRS (3203), Greensboro

27514

Unc Aids Crs (3201), Chapel Hill

30308

The Ponce de Leon Center CRS (5802), Atlanta

35294

Alabama CRS (31788), Birmingham

37204

Vanderbilt Therapeutics (VT) CRS (3652), Nashville

43210

The Ohio State Univ. AIDS CRS (2301), Columbus

44106

Case CRS (2501), Cleveland

45267

Univ. of Cincinnati CRS (2401), Cincinnati

50200

Chiang Mai University HIV Treatment CRS (31784), Chiang Mai

60611

Northwestern University CRS (2701), Chicago

60612

Rush Univ. Med. Ctr. ACTG CRS (2702), Chicago

63110

Washington U CRS (2101), St Louis

75208

Trinity Health and Wellness Center CRS (31443), Dallas

77030

Houston AIDS Research Team CRS (31473), Houston

80045

University of Colorado Hospital CRS (6101), Aurora

90095

UCLA CARE Center CRS (601), Los Angeles

92103

Ucsd, Avrc Crs (701), San Diego

94110

Ucsf Aids Crs (801), San Francisco

9043010

Hospital Nossa Senhora da Conceicao CRS (12201), Porto Alegre

90033-1079

University of Southern California (1201), Los Angeles

02114

Massachusetts General Hospital (MGH) CRS (101), Boston

02115

Brigham and Women's Hosp. ACTG CRS (107), Boston

07103

New Jersey Medical School Clinical Research Center CRS (31786), Newark

02906

The Miriam Hospital ACTG CRS (2951), Providence

00931

Puerto Rico-AIDS CRS (5401), San Juan

Unknown

Joint Clinical Research Centre (JCRC) (12401), Kampala

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

NCT03512210 - Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection | Biotech Hunter | Biotech Hunter