A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)
Trial ID or NCT#
NCT01467479
Status
NOT RECRUITING
Purpose
The purpose of this study is to treat human immunodeficiency virus (HIV) and Hepatitis C Virus (HCV) co-infected subjects with telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) to achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the last planned dose of study drug.
Official Title
An Open Label,Phase 3 Study of Telaprevir in Combination With Peginterferon Alfa 2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Coinfected With Genotype 1 Hepatitis C Virus and Human Immunodeficiency Virus Type 1(HCV/HIV-1)
Eligibility Criteria
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Participants must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA greater than (>) 1000 international units per milliliter (IU/mL) - Population A: HCV Pegylated interferon (Peg-IFN)/RBV treatment naive (received no prior HCV therapy)or Peg-IFN/RBV prior treatment with relapse - Population B: Peg-IFN/RBV prior null or partial responder - Participants must not have achieved undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24) after at least 1 prior course of Peg IFN/RBV therapy of standard duration - Participant must have positive HIV antibody at Screening - Participant must have a diagnosis of HIV-1 infection >6 months before Screening - Participants should be taking 1 of the following permissible highly active antiretroviral therapy (HAART) regimens for HIV continuously for 12 weeks prior to screening: - Atripla® or equivalent components (efavirenz, tenofovir, emtricitabine) - Efavirenz plus Epzicom® (abacavir, lamivudine) or equivalent components - Boosted atazanavir (atazanavir with ritonavir) plus Truvada® (tenofovir, emtricitabine) or equivalent components - Boosted atazanavir plus Epzicom®, or equivalent components - Raltegravir plus Truvada®, or equivalent components - Raltegravir plus Epzicom®, or equivalent components - Cluster of differentiation 4 (CD4) counts and human immunodeficiency virus Type 1 (HIV-1) ribonucleic acid (RNA) meeting acceptable criteria at Screening as specified in the protocol - Laboratory values within acceptable ranges at Screening as specified in the protocol
Exclusion Criteria:
- - Subjects anticipating a need to switch HAART regimens within 14 weeks after Day 1 or any switches occurring 12 weeks prior to Day 1 - Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides - Contraindications to any planned HAART component as per the respective drug labeling information - Contraindications to Peg-IFN or RBV - Evidence of hepatic decompensation - Clinical suspicion of acute hepatitis - Any other cause of liver disease in addition to hepatitis C - History of organ transplantation (except cornea and skin) - Autoimmune-mediated disease - Participated in any investigational drug study within 90 days before Day 1 - Previous treatment with an HCV protease inhibitor
Investigator(s)
Andrew Zolopa
Contact us to find out if this trial is right for you.
Contact
Debbie Slamowitz
(650) 723-2804
View on ClinicalTrials.gov
