Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Vertex Pharmaceuticals Incorporated

Stanford Investigator(s):

Intervention(s):

  • Drug: Telaprevir
  • Drug: Ribavirin
  • Biological: Pegylated Interferon Alfa-2a
  • Drug: Highly Active Antiretroviral Therapy (HAART)

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Debbie Slamowitz
(650) 723-2804
Not Recruiting