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

HIV Infection Clinical Trial

Official title:

Hepatic Safety of Raltegravir-based and Efavirenz-based Antiretroviral Regimens in Antiretroviral-Naïve HIV-infected Subjects Co-Infected With Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147107
• Other study ID #: VHARP 001
• Status: Completed
• Phase: Phase 4
• Start date: February 2014
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2021
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• HIV Infection

Intervention

Drug:
• Raltegravir
Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
• Efavirenz
Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily

Locations

Country	Name	City	State
Vietnam	Viet Tiep General Hospital	Hai Phong
Vietnam	Hospital for Tropical Diseases	Ho Chi Minh City

Sponsors (4)

Lead Sponsor	Collaborator
University of Hawaii	Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Oxford University Clinical Research Unit, Vietnam, Viet Tiep General Hospital, Hai Phong, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	over week 72