Zidovudine Levels in HIV Infected Patients Being Treated for HCV

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will test the amount of anti-HIV drugs in the blood cells of HIV-infected patients who are also being treated for hepatitis C virus (HCV) infection.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b; Ribavirin; Zidovudine

Criteria

Inclusion Criteria

• HCV-infected

• HIV-1 infection

• CD4 cell count > 200 cells/mm³ within 30 days prior to study entry

• HIV RNA < 400 copies/ml within 90 days of study entry

• Use of zidovudine, lamivudine, and any PI and/or NNRTI

• ANC value >= 1,500 ml³ within 30 days of study entry

• Weight > 50 kg (110 lbs) for women and > 60 kg (132 lbs) for men

• Acceptable methods of contraception

• Ability and willingness to complete the Baseline Adherence Questionnaire

• Documentation of adherence confirmed by the Baseline Adherence Questionnaire and certified by the study officials

Exclusion Criteria

• Previous ribavirin therapy

• More than 2 months of interferon therapy

• Current use of any NRTI other than ZDV and 3TC

• Hepatitis B surface antigen positive

• Infectious, autoimmune, tumoral, biliary, or vascular liver disease

• Alcohol consumption of more than 50 g/day

• Current use of intravenous drugs

• Hemoglobin levels < 10 gm/dl

• Methadone use

• Chemotherapy

• Certain medications

• Acute opportunistic or bacterial infection requiring therapy at the time of enrollment

• Hemoglobinopathy (e.g., thalassemia) or any other cause of tendency to hemolysis

• Psychiatric disorders, severe depression, history of suicide attempts, or suicidal ideation

• Renal disease requiring dialysis

• Significant coronary diseases or two or more risk factors for coronary diseases, such as > 55 years old, hypertension, and cholesterol > 250 mg/dl

• Any clinically significant diseases (other than HIV and HCV infection) that, in the opinion of study officials, would compromise the outcome of this study

• Pregnancy

• Participation in blinded clinical trial