Evaluating the Effectiveness of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in Treating Hepatitis C Virus (HCV) Infection in Adults With HIV and HCV Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

262

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
HIV InfectionsHepatitis C
Interventions
DRUG

Pegylated-Interferon Alfa 2b (PEG-IFN)

1.5 mcg/kg subcutaneously (SC) once a week (based on participant's weight at entry) for up to 48 weeks depending on cirrhosis status and, in Group A, Week 8 HCV viral response.

DRUG

Ribavirin (RBV)

800-1400 mg orally per day with food (based on participant's weight at entry) for up to 48 weeks depending on cirrhosis status and, in Group A, Week 8 HCV viral response.

DRUG

Boceprevir (BOC)

800 mg orally every 8 hours with food from Week 5 to up to Week 48 depending on cirrhosis status and, in Group A, Week 8 HCV viral response

Trial Locations (43)

10011

Weill Cornell Chelsea CRS, New York

10065

Weill Cornell Uptown CRS, New York

10457

Bronx-Lebanon Hosp. Ctr. CRS, The Bronx

14642

University of Rochester Adult HIV Therapeutic Strategies Network CRS, Rochester

15213

University of Pittsburgh CRS, Pittsburgh

19104

Penn Therapeutics, CRS, Philadelphia

20007

Georgetown University CRS (GU CRS), Washington D.C.

21201

IHV Baltimore Treatment CRS, Baltimore

21205

Johns Hopkins University CRS, Baltimore

23298

Virginia Commonwealth University CRS, Richmond

27599

Chapel Hill CRS, Chapel Hill

27710

Duke Univ. Med. Ctr. Adult CRS, Durham

35294

Alabama CRS, Birmingham

37204

Vanderbilt Therapeutics (VT) CRS, Nashville

43210

Ohio State University CRS, Columbus

44106

Case Clinical Research Site, Cleveland

44109

MetroHealth CRS, Cleveland

45219

Cincinnati Clinical Research Site, Cincinnati

48201

Wayne State Univ. CRS, Detroit

48202

Henry Ford Hosp. CRS, Detroit

60611

Northwestern University CRS, Chicago

60612

Rush University CRS, Chicago

75208

Trinity Health and Wellness Center CRS, Dallas

77030

Houston AIDS Research Team CRS, Houston

80045

University of Colorado Hospital CRS, Aurora

80204

Denver Public Health CRS, Denver

90035

UCLA CARE Center CRS, Los Angeles

90502

Harbor-UCLA CRS, Torrance

92103

UCSD Antiviral Research Center CRS, San Diego

94110

Ucsf Hiv/Aids Crs, San Francisco

90033-1079

University of Southern California CRS, Los Angeles

94304-5350

Stanford AIDS Clinical Trials Unit CRS, Palo Alto

30308-2012

The Ponce de Leon Center CRS, Atlanta

02114

Massachusetts General Hospital CRS (MGH CRS), Boston

02115

Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS, Boston

02118

Bmc Actg Crs, Boston

63110-1010

Washington University Therapeutics (WT) CRS, St Louis

08103

Cooper Univ. Hosp. CRS, Camden

07103

New Jersey Medical School Clinical Research Center CRS, Newark

10032-3732

Columbia P&S CRS, New York

02906

The Miriam Hospital Clinical Research Site (TMH CRS) CRS, Providence

98104-9929

University of Washington AIDS CRS, Seattle

00935

Puerto Rico AIDS Clinical Trials Unit CRS, San Juan

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01482767 - Evaluating the Effectiveness of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in Treating Hepatitis C Virus (HCV) Infection in Adults With HIV and HCV Infection | Biotech Hunter | Biotech Hunter