Status:
TERMINATED
A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT01467479
Start Date
December 1 2011
End Date
February 1 2014
Last Update
March 17 2015
Active Locations (59)
Enter a location and click search to find clinical trials sorted by distance.
1
Alabama
Birmingham, Alabama, United States
2
California
Bakersfield, California, United States
3
California
Beverly Hills, California, United States
4
California
Coronado, California, United States