Zidovudine Levels in HIV Infected Patients Being Treated for HCV
HIV Infections, Hepatitis C

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV, HCV, Ribavirin, Interferon, Co-infection, Treatment experienced
Eligibility 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
Sites / Locations
- UPR Adult ACTU
Arms of the Study
Arm 1
Experimental
1
Participants will begin receive either Rebetron or PEG-Intron plus ribavirin therapy from Weeks 2 through 48