Status:
COMPLETED
Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection
Lead Sponsor:
University of Hawaii
Collaborating Sponsors:
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Viet Tiep Hospital
Conditions:
Hepatitis C, Chronic
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 an...
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 raltegravi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01147107
Start Date
February 1 2014
End Date
June 1 2021
Last Update
August 13 2021
Active Locations (2)
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1
Viet Tiep General Hospital
Haiphong, Vietnam
2
Hospital for Tropical Diseases
Ho Chi Minh City, Vietnam