CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
Peg-interferon + ribavirin under HIV physician supervisiondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02247440
NCT02247440Phase 4Completed

Response to Peg-interferon and Ribavirin for the Treatment of HCV Infection in HIV Co-infected Patients, Implemented in Public Hospitals in Thailand

Institut de Recherche pour le Developpement·interventional·Posted Sep 25, 2014·Updated Jun 3, 2019

In Brief

A Phase 4 clinical trial evaluating Peg-interferon + ribavirin under HIV physician supervision for Hepatitis C Infection and HIV. Completed, enrolled 18 participants across 5 sites.

Detailed Summary

This is a study of HCV treatment using the standard regimen of pegylated-interferon plus ribavirin in HIV co-infected patients participating in the PHPT cohort study. The treatment will be implemented in conjunction with gastro-enterologists/hepatologists by internists responsible for the participant's HIV treatment. Chronic hepatitis C virus (HCV) infection is responsible for several severe and life threatening complications, which are worsened by HIV co-infection. HIV-HCV co-infected patients are at a higher risk of death compared to HIV mono-infected individuals, even if HIV replication is suppressed on antiretroviral treatment. The goal of HCV antiviral treatment is to cure HCV infection. Curing HCV infection allows fibrosis regression, improved clinical outcomes. In addition, individuals who have been cured are no longer contagious to other individuals, therefore widespread access to HCV treatment may contribute to the control of the HCV epidemic. A combination of injectable pegylated-interferon with oral ribavirin is currently the recommended regimen for the treatment of hepatitis C in the setting of HIV co-infection. They are administered for 24 weeks in HCV mono-infected patients but need to be administered for one year in HIV-HCV co-infected patients. Newer drugs, such as the first generation HCV protease inhibitors (boceprevir, telaprevir), administered concomitantly, are used in patients who have not been cured using peg-interferon + ribavirin, and may allow for shorter treatment. PRIMARY OBJECTIVE 1\. To determine the percentage of patients according to genotypes with sustained virological response 6 months after treatment discontinuation (SVR). HCV TREATMENT * Peg-interferon alpha 2-b (a subcutaneous injection of 1.5 micrograms/kg once a week) * Ribavirin dosing according to HCV genotype and body weight; dose adjustment in case of anemia. A total of 60 patients could be enrolled in the study: 15 HCV-HIV co-infected patients in a first part (starting in August 2014) and 45 patients in a second part, depending on funding.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesThailand

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 25, 2014
Enrollment StartAug 1, 2014
Primary CompletionMay 1, 2017
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11.8 years ago

Interventions

Peg-interferon + ribavirin under HIV physician supervisiondrug

Peg-interferon + ribavirin under HIV physician supervision