CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Raltegravir +1 moredrug
Likely dose
Raltegravir 200 mgfrom 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/NCT01147107
NCT01147107Phase 4Completed
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Hepatic Safety of Raltegravir-based and Efavirenz-based Antiretroviral Regimens in Antiretroviral-Naïve HIV-infected Subjects Co-Infected With Hepatitis C

University of Hawaii·interventional·Posted Jun 22, 2010·Updated Aug 13, 2021

In Brief

A Phase 4 clinical trial evaluating Raltegravir and Efavirenz for Hepatitis C, Chronic and HIV Infection. Completed, enrolled 80 participants across 2 sites.

Detailed Summary

The main objective is to evaluate the hepatic safety of raltegravir when compared to efavirenz, both in combination with tenofovir and emtricitabine as first-line HIV treatment in patients with HIV and hepatitis C coinfection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic, HIV Infection
CountriesVietnam
CollaboratorsHospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Viet Tiep Hospital, Oxford University Clinical Research Unit, Vietnam

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2010
Enrollment StartFeb 1, 2014
Primary CompletionJun 1, 2016
Study CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.0 years ago

Interventions

Raltegravirdrug

Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily

Efavirenzdrug

Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily