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Home > "E" Clinical Trials Conditions > Effects of Ribavirin on Zidovudine or Stavudine  Effects of Ribavirin on Zidovudine or Stavudine
Effects of Ribavirin on Zidovudine or Stavudine
For Condition: HIV Infections,Hepatitis C
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see how treatment of hepatitis C (HCV) patients with ribavirin (RBV) affects the anti-HIV drugs stavudine (d4T) or zidovudine (ZDV). Studies have shown that RBV may interfere with the action of ZDV and d4T. There is little information about the way these drugs interact in the body. This study will examine how the drug RBV affects levels of ZDV or d4T in patients who are currently on stable anti-HIV therapy.
Details: RBV, a nucleoside analogue, is used for the treatment of hepatitis C virus (HCV) in alliance with interferon-alfa 2a/2b in patients with HIV-1. The mechanism of action of RBV has led to in vitro studies examining the agonism/antagonism in efficacy occurring when used in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The primary objective of the pharmacology component of this current study will be the evaluation of the effect of RBV on the intracellular activation of ZDV or d4T owing to the reported antagonism observed in vitro. Pharmacokinetic (PK) evaluations for plasma ZDV or d4T and intracellular ZDV or d4T and measurements of their triphosphate anabolites are performed before initial RBV dosing (within 2 weeks of visit) and 8 weeks after RBV administration. Thymidine triphosphate (TTP) concentrations also are quantitated to permit estimation of the ratio of active drug to endogenous triphosphate concentrations. For entry, prior to RBV dosing, blood samples are collected within 2 hours prior to the ZDV or d4T dose and then at Hours 1, 4, 6, and 8 post dosing. Following the entry PK blood draws, patients initiate RBV treatment within 2 weeks of the first PK study day. For the Week 8 evaluation (measured as 8 weeks following initiation of RBV), blood samples are collected prior to the ZDV or d4T dose and then at Hours 1, 4, 6, and 8 post dosing.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are at least 13 years of age. - Have written consent from parent or guardian if under 18 years of age. - Have HIV infection. - Have been receiving ZDV or d4T for at least 4 weeks prior to study entry. - Are planning to receive RBV-containing hepatitis treatment through their doctor or through coenrollment in another ACTG protocol within 2 weeks following entry into the study. - Have not received RBV for at least 6 months prior to study entry if they were previously treated with RBV. - Weigh more than 110 pounds (50 kg). Exclusion Criteria Patients will not be eligible for this study if they: - Are pregnant. - Use rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir, or hydroxyurea within 14 days of study entry. - Abuse alcohol or drugs. Patients in methadone programs may participate.
Total Enrollment: 32
Location and Contact Information:
Overall Study Official:
FrancescaAweeka, Study Chair,
Willow Clinic / Stanford Univ *No longer recruiting*
Stanford, California, 94305
United States
No longer recruiting
San Mateo AIDS Program / Stanford Univ *No longer recruiting*
Stanford, California, 943055107
United States
No longer recruiting
UCLA CARE Ctr *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Susan McCarthy 310-206-8029
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109-1998
United States
Recruiting Ann Conrad 216-778-5489
Johns Hopkins Hosp *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Charles Raines 410-614-4487
Stanford Univ Med Ctr *Recruiting*
Stanford, California, 943055107
United States
Recruiting Debbie Slamowitz 650-723-2804
Additional Information:
Study ID Numbers: ACTG A5092s; AACTG A5092s
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021632
Other Hiv Infections Studies:
1. Peginterferon alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients
2. Immune Response to Hepatitis C Virus
3. A Comparison of the Effectiveness, Safety, and Tolerability of Two Different Hepatitis C Treatments in Patients Infected with Both HIV and Hepatitis C Virus (HCV)
4. The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections
5. Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Effects of Ribavirin on Zidovudine or Stavudine
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