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Lead
Vertex Pharmaceuticals Incorporated
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)
