NCT01718301

HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin

A Study to Evaluate Safety and Efficacy of Boceprevir-response Guided Therapy in Controlled HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin Eudra CT2012-003984-23

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Anna Cruceta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and efficacy of a Response Guided Therapy of boceprevir 800 mg dosed three times a day (TID) orally (PO) in combination with Peginterferon (either alpha 2b or alpha 2a) and Ribavirin in HIV/HCV genotype 1 infected patients that failed to previous HCV therapy.

Detailed description

In a total number of 108 patients the protocol was evaluated but only in 102 the protocol efectively was presented. In the remaining 6 patients we don't believe the trial could be performed.

Conditions

• Hepatitis C
• HIV Infections
• COINFECTION

Interventions

Type	Name	Description
DRUG	boceprevir
DRUG	Ribavirin
DRUG	Peginterferon alfa-2a
DRUG	Peginterferon alfa-2b

Timeline

• Start date: 2013-03-10
• Primary completion: 2015-03-20
• Completion: 2015-06-30
• First posted: 2012-10-31
• Last updated: 2025-08-24
• Results posted: 2025-08-24

Locations

1 site across 1 country: Spain