Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Quinine sulfate (Drug); Probenecid (Drug); Zidovudine (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Kornhauser D, Study Chair
Summary
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.
Clinical Details
Official title: Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine
Study design: Masking: Open Label, Primary Purpose: Treatment
Detailed description:
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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).
Locations and Contacts
Johns Hopkins Hosp, Baltimore, Maryland 21287, United States
Additional Information
Click here for more information about Zidovudine
Related 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.
Last updated: March 15, 2012
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