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

Not Recruiting

Trial ID: NCT01467479


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)

Stanford Investigator(s)

Philip Grant
Philip Grant

Assistant Professor of Medicine (Infectious Diseases)


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

      - 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

   - 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


drug: Telaprevir

drug: Ribavirin

biological: Pegylated Interferon Alfa-2a

drug: Highly Active Antiretroviral Therapy (HAART)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Debbie Slamowitz
(650) 723-2804