Overview

This trial is active, not recruiting.

Conditions hepatitis c, chronic, hiv infection
Treatments raltegravir, efavirenz
Phase phase 4
Sponsor University of Hawaii
Collaborator Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Start date February 2014
End date December 2016
Trial size 80 participants
Trial identifier NCT01147107, VHARP 001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
raltegravir Isentress
Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
(Active Comparator)
Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
efavirenz Sustiva
Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily

Primary Outcomes

Measure
Rates of Grade 2 and higher alanine aminotransferase (ALT) elevations
time frame: over week 72

Secondary Outcomes

Measure
Plasma HIV RNA </= 150 copies/mL by the Abbot M2000 platform
time frame: 24 weeks and 72 weeks
Change in CD4 count
time frame: from entry to week 24, from entry to week 72
Time to death and/or occurrence of new or recurrent AIDS-defining events
time frame: entry to week 24, entry to week 72
Changes in fasting blood glucose and cholesterol measures
time frame: entry to week 24, entry to week 72
Changes in monocyte and T cell immune activation
time frame: entry to week 24, entry to week 48
Neurocognitive function
time frame: entry to week 24, entry to week 72

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Hepatic Safety of Raltegravir-based and Efavirenz-based Antiretroviral Regimens in Antiretroviral-Naïve HIV-infected Subjects Co-Infected With Hepatitis C
Principal investigator Van Vinh Chau Nguyen, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Hawaii.