A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)
Status: | Recruiting |
---|---|
Conditions: | HIV / AIDS, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 9/23/2012 |
Start Date: | January 2012 |
Contact: | Central Contact Center |
Email: | medicalinfo@vrtx.com |
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)
The purpose of this study is to treat HIV and HCV coinfected subjects with telaprevir,
peg-interferon alfa-2a, and ribavirin to achieve undetectable HCV RNA 12 weeks after the
last planned dose of study drug.
Inclusion Criteria:
- Subjects must have chronic, genotype 1a or 1b, hepatitis C with HCV RNA >1000 IU/mL
- Population A: HCV Peg IFN/RBV treatment naive (received no prior HCV therapy)or
Peg-IFN/RBV prior treatment with relapse
- Population B: Peg-INF/RBV prior null or partial responder
- Subjects must not have achieved SVR24 after at least 1 prior course of Peg IFN/RBV
therapy of standard duration
- Subject must have positive HIV antibody at Screening
- Subject must have a diagnosis of HIV-1 infection >6 months before Screening
- Subjects should be taking 1 of the following permissible 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
- CD4 counts and HIV-1 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
We found this trial at
27
sites
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