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

Trial ID or NCT#

NCT01467479

Status

not recruiting iconNOT RECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Philip Grant
Philip Grant
Positive care doctor, Infectious disease doctor
Assistant Professor of Medicine (Infectious Diseases)
Andrew Zolopa

Contact us to find out if this trial is right for you.

Contact

Debbie Slamowitz
(650) 723-2804

View on ClinicalTrials.gov