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Effects of Ribavirin on Zidovudine or Stavudine

15. maj 2015 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- California
  - Los Angeles, California, Forenede Stater, 90095
    - UCLA CARE Ctr
  - Stanford, California, Forenede Stater, 943055107
    - San Mateo AIDS Program / Stanford Univ
  - Stanford, California, Forenede Stater, 943055107
    - Stanford Univ Med Ctr
  - Stanford, California, Forenede Stater, 94305
    - Willow Clinic / Stanford Univ
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21287
    - Johns Hopkins Hosp
- Ohio
  - Cleveland, Ohio, Forenede Stater, 44109-1998
    - MetroHealth Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

13 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Aweeka FT, Kang M, Yu JY, Lizak P, Alston B, Chung RT; AIDS Clinical Trials Group 5092s Study Team. Pharmacokinetic evaluation of the effects of ribavirin on zidovudine triphosphate formation: ACTG 5092s Study Team. HIV Med. 2007 Jul;8(5):288-94. doi: 10.1111/j.1468-1293.2007.00472.x. Erratum In: HIV Med. 2007 Sep;8(6):412.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Datoer for studieregistrering

Først indsendt

26. juli 2001

Først indsendt, der opfyldte QC-kriterier

30. august 2001

Først opslået (Skøn)

31. august 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2015

Sidst verificeret

1. juli 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

ACTG A5092s
AACTG A5092s
10919 (Registry Identifier: DAIDS-ES)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .