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Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000706
First received: November 2, 1999
Last updated: March 15, 2012
Last verified: March 2012
History of Changes

November 2, 1999
March 15, 2012
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Complete list of historical versions of study NCT00000706 on ClinicalTrials.gov Archive Site
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Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine
Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine

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.

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.
Interventional
Not Provided
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Quinine sulfate
  • Drug: Probenecid
  • Drug: Zidovudine
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 1988
Not Provided

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000706
ACTG 027, 11003
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Kornhauser D
National Institute of Allergy and Infectious Diseases (NIAID)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP