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

• Status: Completed
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Hawaii
• Collaborators: Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam; Oxford University Clinical Research Unit, Vietnam; Viet Tiep General Hospital, Hai Phong, Vietnam
• Treatments: Efavirenz; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Raltegravir Potassium; Tenofovir

Criteria

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