Effects of Anti-HIV Drugs on the Hepatitis C Virus (HCV) in Adults Infected With Both HCV and HIV

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to measure the effects of anti-HIV drugs on hepatitis C virus (HCV) viral load in people infected with both HCV and HIV.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Efavirenz; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• HCV-infected

• HIV-infected

• Liver biopsy consistent with chronic hepatitis within 1 year of study entry.

• ART-naive or no ART for at least 3 months prior to study entry

Exclusion Criteria:

• Hemoglobin less than 9 g/dl.

• Hepatitis B virus infected or antibody to hepatitis B core antigen, alpha-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, autoimmune disorder, or other concurrent liver disease

• Decompensated liver disease evidenced by active or history of encephalopathy, ascites, or variceal bleeding; prothrombin time (PT) greater than 3 seconds above normal or international normalized ratio (INR) greater than 1.3 sec; platelet count less than 90,000 K/ul. Participants with cirrhosis will not be excluded.

• Active thyroid disease. Participants on thyroid replacement therapy with normal thyroid-stimulating hormone are not excluded.

• Chronic kidney insufficiency, defined as creatinine clearance of greater than approximately 50 ml/min

• Life-threatening disease processes other than HIV or HCV that could interfere with participation in the study

• Any condition that, in the opinion of the investigator, may interfere with completion of the study regimen. This includes severe psychiatric disorders, or active alcohol or recreational drug abuse

• Use of systemic corticosteroids or immunomodulatory drugs within 1 month prior to study entry

• Current or prior successful interferon treatment

• Pregnancy or breastfeeding