An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic Hepatitis C Virus (HCV-1) and Human Immunodeficiency Virus (HIV-1)

PHASE3CompletedINTERVENTIONAL
Enrollment

163

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

March 31, 2014

Study Completion Date

June 30, 2014

Conditions
Chronic Hepatitis C
Interventions
DRUG

Telaprevir

Type=exact number, unit=mg, number=750 or 1125, form=tablet, route=oral. the patients will receive 2 oral tablets every 8 hours for 12 weeks except for patients on efavirenz who will receive 1125mg (3 oral tablets) every 8 hours for 12 weeks.

DRUG

Ribavirin

Type=exact number, unit=mg, number=400, form=tablet, route=oral. The patients will receive 2 oral ribavirin tablets twice daily for 24 or 48 weeks, based on the response guided therapy.

DRUG

Pegylated-Interferon-alfa-2a

Type=exact number, unit=microgram, number=180, form=injection, route=subcutaneous The patients will receive Peg-IFN-alfa-2a 180 microgram once a week for 24 or 48 weeks; based on the response guided therapy.

Trial Locations (31)

Unknown

Cairns

Darlinghurst

Melbourne

Campinas

Rio de Janeiro

Santo André

São Paulo

Le Kremlin-Bicêtre

Marseille

Nice

Paris

Bydgoszcz

Mysłowice

Warsaw

Krasnodar

Perm

Saint Petersburg

Smolensk

Voronezh

Alicante

Badalona

Córdoba

Donostia / San Sebastian

Elche

Madrid

Seville

Valencia

Stockholm

Birmingham

Glasgow

London

Sponsors
All Listed Sponsors
lead

Janssen-Cilag International NV

INDUSTRY