Conditions: Hepatitis C, Chronic HIV Infection
Keywords: HIV/HCV co-infection Antiretroviral therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily arm 2: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily

Interventions: intervention 1: Raltegravir intervention 2: Efavirenz
Intervention descriptions: intervention 1: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily intervention 2: Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily

Protocol document: