Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection

University of Hawaii80 enrolled

Overview

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.

The trial will recruit 80 treatment-naive HIV-infected patients with chronic hepatitis C coinfection from two HIV treatment centers in Vietnam. Patients will be randomized to receive either raltegravir or efavirenz, both in combination of tenofovir and emtricitabine, as first-line HIV therapy over a period of 72 weeks. The primary endpoint is the rate of alanine aminotransferase (ALT) elevation during the 72 week study period. Secondary endpoints include rates of virological suppression, CD4 count change, numbers of AIDS events and death, rates of fasting glucose and cholesterol measures, neurocognitive function and levels of immune activation. Patients will be followed monthly for the first 3 months and every 3 months thereafter. At the end of the trial period, patients will be transferred to the National HIV treatment program for continuation of HIV therapy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C, Chronic HIV Infection

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HIV infected patients, age \>18 years, meet Vietnam guideline to begin ART (CD4 count \< 350 cells/mm3 and/or WHO stage III or IV disease) * Hepatitis C infection as documented by positive HCV antibodies and a detectable serum HCV RNA level * AST and ALT ≤ 2 x ULN (≤ 80 U/L) * Estimated creatinine clearance ≥ 60 mL/min Exclusion Criteria: * Any prior ART * Positive Hepatitis B surface antigen * Clinical evidence of de-compensated cirrhosis (ascites, encephalopathy, esophageal bleeding) * Requirement for acute therapy for other AIDS-defining illness within 14 days prior to study entry * Currently on rifampicin therapy * In the first trimester of pregnancy, intent to become pregnant, or breast feeding during the study period

Locations (2)

Viet Tiep General Hospital

Haiphong, Vietnam

Hospital for Tropical Diseases

Ho Chi Minh City, Vietnam

Outcomes

Primary Outcomes

Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations

To estimate the rates of grade 2\*and higher ALT elevations in the two regimens.

Time frame: over week 72

Data from ClinicalTrials.gov

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