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Home > "Z" Clinical Trials Conditions > Zidovudine Levels in HIV Infected Patients Being Treated for HCV  Zidovudine Levels in HIV Infected Patients Being Treated for HCV
Zidovudine Levels in HIV Infected Patients Being Treated for HCV
For Condition: HIV Infections,HCV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: An estimated 50,000 people in Puerto Rico are infected with HCV. HIV and HCV have similar routes of transmission, and HCV co-infection occurs in 8% to 23% of HIV infected patients. Researchers have shown that treatment for HCV with Rebetron (ribavirin plus interferon alfa-2b) significantly decreases HCV viral load without affecting HIV viral load. However, measurements of intracellular levels of the active forms of zidovudine (ZDV-MP and ZDV-TP) were not performed. Such measurements are needed to provide a more rational basis for dosing in HIV/HCV co-infected patients. This study will investigate the intracellular exposure to active ZDV metabolites prior to and after treatment with Rebetron or treatment with PEG-Intron (pegylated interferon) and ribavirin. Participants in this study will remain on their usual antiretroviral regimen; no changes may be made to that regimen for the first 4 weeks of the study. Upon study entry, participants will have intracellular pharmacokinetic studies. During Week 2, participants will start either Rebetron or PEG-Intron plus ribavirin therapy, will have intracellular pharmacokinetic studies, and will undergo liver biopsy. Additional intracellular pharmacokinetic studies will be performed at Weeks 12 and 24. Rebetron or PEG-Intron plus ribavirin will be given for 48 weeks. A second liver biopsy will be performed 24 weeks after discontinuing Rebetron or PEG-Intron plus ribavirin therapy. Participants will be followed for 72 weeks.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 21 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HCV infection - 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
Total Enrollment: 16
Location and Contact Information:
Overall Study Official:
JoseRodriguez, Principal Investigator, MSC-UPR
UPR Adult ACTU *Recruiting*
San Juan, , 00936-5067
Puerto Rico
Recruiting Daniel Casiano 787-767-9195
Additional Information:
Study ID Numbers: 1R01AIA9141-01A1; 5R01AI049141-02
Study Start Date: September 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059358
Other Hcv Infections Studies:
1. A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
2. A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
3. A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
4. The Effect of Oral Candidiasis on the Speech Production, Feeding Skills, and Self-Concept of Children and Adolescents with Symptomatic HIV Infection
5. A Study to Evaluate the Safety and Efficacy of Azithromycin in Individual Patients With Serious Nontuberculous Mycobacterial Disease Who Are Failing or Intolerant of Other Available Therapy
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Zidovudine Levels in HIV Infected Patients Being Treated for HCV
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