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

Stopped early · Phase 3

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT01467479

Run by

Vertex Pharmaceuticals Incorporated

People needed

185

Starts

2011-12-01

Expected to finish

2014-02-01

Last updated by the study team

2015-03-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• California — Bakersfield, California, United States
• California — Beverly Hills, California, United States
• California — Coronado, California, United States
• California — Los Angeles, California, United States
• California — Oakland, California, United States
• California — Palo Alto, California, United States
• California — Sacremento, California, United States
• California — San Diego, California, United States
• California — San Francisco, California, United States
• Connecticut — New Haven, Connecticut, United States
• DC — Washington D.C., District of Columbia, United States
• Washington, DC — Washington D.C., District of Columbia, United States
• Florida — Bay Pines, Florida, United States
• Florida — Jacksonville, Florida, United States
• Florida — Miami, Florida, United States
• Florida — Orlando, Florida, United States
• Florida — West Palm Beach, Florida, United States
• Georgia — Atlanta, Georgia, United States
• Georgia — Decatur, Georgia, United States
• Illinois — Chicago, Illinois, United States
• Maine — Portland, Maine, United States
• Maryland — Baltimore, Maryland, United States
• Maryland — Lutherville, Maryland, United States
• Massachusetts — Springfield, Massachusetts, United States
• Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.