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

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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
Gainesville, Florida
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Gainesville, FL
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, Georgia
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, GA
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Albuquerque, New Mexico
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Albuquerque, NM
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Baltimore, Maryland
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Baltimore, MD
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Birmingham, Alabama
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Birmingham, AL
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Boston, Massachusetts
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Boston, MA
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Chapel Hill, North Carolina
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Chapel Hill, NC
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Chicago, Illinois
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Chicago, IL
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Cincinnati, Ohio
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Cincinnati, OH
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Columbia, South Carolina
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Columbia, SC
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Coronado, California
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Coronado, CA
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Fairfax, Virginia
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Fairfax, VA
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Houston, Texas
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Houston, TX
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Manhasset, New York
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Manhasset, NY
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Minneapolis, Minnesota
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Minneapolis, MN
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New Haven, Connecticut
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New Haven, CT
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Newark, New Jersey
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Newark, NJ
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Novi, Michigan
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Novi, MI
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Philadelphia, Pennsylvania
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Philadelphia, PA
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Portland, Maine
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Portland, ME
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Portland, Oregon
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Portland, OR
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Providence, Rhode Island
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Providence, RI
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Salt Lake City, Utah
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Salt Lake City, UT
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Seattle, Washington
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Seattle, WA
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St Louis, Missouri
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St Louis, MO
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Washington, District of Columbia
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Washington,
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DC
Washington DC, District of Columbia
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Washington DC,
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