Telaprevir Open-Label Study in Co-Infected Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

August 31, 2014

Conditions
Hepatitis C, Chronic
Interventions
DRUG

Telaprevir

type = exact number, unit = mg, number = 750, form = tablet, route = oral use, every 8 hours for 12 weeks in combination with pegylated interferon alfa (Peg-IFN alfa) and ribavirin (RBV) during 48 weeks for eligible non treated HIV patients and for patients whose highly active antiretroviral therapy (HAART) regimen is the combination of ritonavir-boosted atazanavir, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or the combination of raltegravir, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or etravirine, TDF, plus either emtricitabine or lamivudine, or etravirine, abacavir, plus either emtricitabine or lamivudine, or rilpivirine, TDF, plus either emtricitabine or lamivudine, or rilpivirine, abacavir, plus either emtricitabine or lamivudine.

DRUG

Telaprevir

type = exact number, unit = mg, number = 1125, form = tablet, route = oral use, every 8 hours for 12 weeks in combination with Peg-IFN alfa and RBV during 48 weeks when patient's HAART regimen is the combination of efavirenz, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or etravirine, TDF, plus either emtricitabine or lamivudine, or etravirine, abacavir, plus either emtricitabine or lamivudine, or rilpivirine, TDF, plus either emtricitabine or lamivudine, or rilpivirine, abacavir, plus either emtricitabine or lamivudine.

Trial Locations (29)

Unknown

Antwerp

Brussels

Charleroi

Ghent

Leuven

Liège

Berlin

Bonn

Cologne

Dortmund

Frankfurt

Hanover

Stuttgart

Tübingen

Budapest

Dublin

Luxembourg

Amadora

Lisbon

Porto

Perm

Saint Petersburg

Tolyatti

Volgograd

Yoshkar-Ola

Glasgow

Liverpool

London

Plymouth

Sponsors
All Listed Sponsors
lead

Janssen-Cilag International NV

INDUSTRY