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

University of Hawaii

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic; HIV Infection

Treatments: Drug: Efavirenz; Drug: Raltegravir

Study type: Interventional

Funder types: Other

Identifiers

NCT01147107

VHARP 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Raltegravir based therapy

Experimental group

Description:

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

Treatment:

Drug: Raltegravir

Efavirenz based therapy

Active Comparator group

Description:

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

Treatment:

Drug: Efavirenz