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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
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)
Stanford Investigator(s)
Philip Grant
Assistant Professor of Medicine (Infectious Diseases)
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
Intervention(s):
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