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

Completed · Phase 1

Conditions studied: Hepatitis C, HIV Infections

In brief

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.

Key facts

Study ID

NCT00545558

Run by

University of Cincinnati

People needed

18

Starts

2006-04-01

Expected to finish

2012-03-01

Last updated by the study team

2014-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• General Clinical Research Center (GCRC), OH site — Cincinnati, Ohio, United States
• Virginia Commonwealth University, School of Medicine — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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