Trials / Terminated
TerminatedNCT01467479
A Study to Treat Subjects With Telaprevir, Ribavirin, and Peginterferon Who Are Coinfected With HIV and Hepatitis C Virus (HCV)
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)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 185 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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 (RBV) to achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA) 12 weeks after the last planned dose of study drug.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Telaprevir | Tablet |
| DRUG | Ribavirin | Tablet |
| BIOLOGICAL | Pegylated Interferon Alfa-2a | Subcutaneous Injection |
| DRUG | Highly Active Antiretroviral Therapy (HAART) | Atazanavir/ritonavir (ATV/r) based HAART, Efavirenz (EFV) based HAART, or Raltegravir (RAL) based HAART, as per standard practice. HAART medications were not considered study drugs. |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2014-02-01
- Completion
- 2014-02-01
- First posted
- 2011-11-08
- Last updated
- 2015-03-17
- Results posted
- 2015-03-17
Locations
59 sites across 5 countries: United States, Canada, Germany, Puerto Rico, Spain
Source: ClinicalTrials.gov record NCT01467479. Inclusion in this directory is not an endorsement.