A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Telaprevir; Ribavirin; Pegylated Interferon Alfa-2a; Highly Active Antiretroviral Therapy (HAART)
Intervention description: Tablet; Tablet; Subcutaneous Injection; Atazanavir/ritonavir (ATV/r) based HAART, Efavirenz (EFV) based HAART, or Raltegravir (RAL) based HAART, as per standard practice. HAART medications were not considered study drugs.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Anti-Retroviral Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

Eligibility 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