- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00021632
Effects of Ribavirin on Zidovudine or Stavudine
Pharmacokinetic Evaluation of the Effects of Ribavirin (RBV) on Zidovudine (ZDV) or Stavudine (d4T) Triphosphate (TP) Formation
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving
Contacten en locaties
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90095
- UCLA CARE Ctr
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Stanford, California, Verenigde Staten, 943055107
- San Mateo AIDS Program / Stanford Univ
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Stanford, California, Verenigde Staten, 943055107
- Stanford Univ Med Ctr
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Stanford, California, Verenigde Staten, 94305
- Willow Clinic / Stanford Univ
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21287
- Johns Hopkins Hosp
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44109-1998
- MetroHealth Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Medewerkers en onderzoekers
Publicaties en nuttige links
Studie record data
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ACTG A5092s
- AACTG A5092s
- 10919 (Register-ID: DAIDS-ES)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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