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

Phase 4

Completed

• Conditions: HIV Infection; Hepatitis C, Chronic
• Interventions: Drug: Efavirenz; Drug: Raltegravir

• Registration Number: NCT01147107
• Lead Sponsor: University of Hawaii

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.

Study Timeline

• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-22
• Study Start: 2014-02
• Primary Completion: 2016-06-01
• Study Completion: 2021-06-01
• Status Verified: 2021-07
• Results First Submitted: 2021-07-21
• Results First Submitted QC: 2021-07-21
• Last Update Submitted: 2021-07-21
• Results First Posted: 2021-08-13
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Efavirenz based therapy	Efavirenz	Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
Raltegravir based therapy	Raltegravir	Emtricitabine/tenofovir DF\* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily

Primary Outcome Measures

Name	Time	Method
Rates of Grade 2 and Higher Alanine Aminotransferase (ALT) Elevations	over week 72	To estimate the rates of grade 2\*and higher ALT elevations in the two regimens.

Trial Locations

Locations (2)

Viet Tiep General Hospital; 🇻🇳 Hai Phong, Vietnam

Hospital for Tropical Diseases; 🇻🇳 Ho Chi Minh City, Vietnam