A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)

• Status: Terminated
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Anti-Retroviral Agents; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

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