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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00021632 |
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.
Condition |
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HIV Infections Hepatitis C |
Study Type: | Observational |
Official Title: | Pharmacokinetic Evaluation of the Effects of Ribavirin (RBV) on Zidovudine (ZDV) or Stavudine (d4T) Triphosphate (TP) Formation |
Estimated Enrollment: | 32 |
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, 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, and 8 post dosing.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, California | |
Stanford Univ Med Ctr | |
Stanford, California, United States, 943055107 | |
UCLA CARE Ctr | |
Los Angeles, California, United States, 90095 | |
San Mateo AIDS Program / Stanford Univ | |
Stanford, California, United States, 943055107 | |
Willow Clinic / Stanford Univ | |
Stanford, California, United States, 94305 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Ohio | |
MetroHealth Medical Center | |
Cleveland, Ohio, United States, 44109-1998 |
Study Chair: | Francesca Aweeka |
Study ID Numbers: | ACTG A5092s, AACTG A5092s |
Study First Received: | July 26, 2001 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00021632 History of Changes |
Health Authority: | United States: Federal Government |
Ribavirin Drug Interactions Drug Therapy, Combination Zidovudine Stavudine |
Reverse Transcriptase Inhibitors Anti-HIV Agents Pharmacokinetics Area Under Curve |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Liver Diseases Anti-HIV Agents Stavudine Ribavirin Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Zidovudine Antiviral Agents |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Hepatitis Virus Diseases Digestive System Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Hepatitis C Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Liver Diseases Slow Virus Diseases Stavudine Flaviviridae Infections Molecular Mechanisms of Pharmacological Action Ribavirin Hepatitis, Viral, Human Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses |
Hepatitis C Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases HIV Infections |