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Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine - Article


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Quinine

Quinamm; Quiphile


Clinical Trial: Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

Part I studies the effect of quinine on how zidovudine (AZT) is used by the body and eliminated through the kidneys in HIV infected patients. Part II studies the effect of probenecid and quinine on the same aspects. Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT needed for treatment.

Condition Treatment or Intervention
HIV Infections
 Drug: Quinine sulfate
 Drug: Probenecid
 Drug: Zidovudine

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Open Label

Further Study Details: 

Expected Total Enrollment:  12

Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT needed for treatment.

In part I, four patients who are now receiving AZT at the usual dose take part in pharmacokinetic studies (how much of the drug enters the blood stream, what happens to the drug in the body, and how it leaves the body) of AZT defined after a dose while at steady state and then again after a new steady state has been reached following the addition of quinine sulfate. Part II studies the pharmacokinetics of AZT in eight patients receiving AZT at 1 of 2 doses and then at the lower dose of AZT plus probenecid with or without quinine.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients must:

  • Have symptomatic HIV infection.
  • Be taking zidovudine (AZT), 100 or 200 mg, 5 or 6 x/day. Allowed:
  • History of Pneumocystis carinii pneumonia (PCP).
  • Advanced AIDS related complex (ARC).
  • HIV antibody positive with an absolute CD4 lymphocyte count of < 200 cells/mm3 before study entry.

Exclusion Criteria

Co-existing Condition: Patients with any of the following conditions are excluded:

  • Glucose-6-phosphate dehydrogenase deficiency.
  • Allergy to sulfa drugs, probenecid, or quinine. Concurrent Medication: Excluded:

Other drugs that might influence the metabolism or renal excretion of zidovudine (AZT).


Location Information


Maryland
      Johns Hopkins Hosp, Baltimore,  Maryland,  21287,  United States

Study chairs or principal investigators

Kornhauser D,  Study Chair

More Information

Click here for more information about Zidovudine

Publications

Kornhauser DM, Petty BG, Hendrix CW, Woods AS, Nerhood LJ, Bartlett JG, Lietman PS. Probenecid and zidovudine metabolism. Lancet. 1989 Aug 26;2(8661):473-5.

Study ID Numbers:  ACTG 027
Record last reviewed:  October 1991
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000706
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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August 28, 2008



Page Updated: June 1, 2005
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