Effects of Ribavirin on Zidovudine or Stavudine
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| ClinicalTrials.gov Identifier: NCT00021632 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : May 19, 2015
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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 or disease |
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| HIV Infections Hepatitis C |
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.
| Study Type : | Observational |
| Enrollment : | 32 participants |
| Official Title: | Pharmacokinetic Evaluation of the Effects of Ribavirin (RBV) on Zidovudine (ZDV) or Stavudine (d4T) Triphosphate (TP) Formation |
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| Ages Eligible for Study: | 13 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021632
| United States, California | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| San Mateo AIDS Program / Stanford Univ | |
| Stanford, California, United States, 943055107 | |
| Stanford Univ Med Ctr | |
| 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 |
Publications of Results:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00021632 History of Changes |
| Other Study ID Numbers: |
ACTG A5092s AACTG A5092s ACTG A5092s 10919 ( Registry Identifier: DAIDS-ES ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | May 19, 2015 |
| Last Verified: | July 2013 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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Ribavirin Drug Interactions Drug Therapy, Combination Zidovudine Stavudine |
Reverse Transcriptase Inhibitors Anti-HIV Agents Pharmacokinetics Area Under Curve |
Additional relevant MeSH terms:
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Hepatitis C HIV Infections Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis Liver Diseases Digestive System Diseases Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Ribavirin Zidovudine Stavudine Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Anti-HIV Agents |