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Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00000706
Collaborator
(none)
12
Enrollment
1
Location

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine
Actual Study Completion Date :
Dec 1, 1988

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Hosp Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Study Chair: Kornhauser D,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT00000706
    Other Study ID Numbers:
    • ACTG 027
    • 11003
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Nov 3, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
    Quinine
    Probenecid
    Drug Therapy, Combination
    Acquired Immunodeficiency Syndrome
    AIDS-Related Complex
    Zidovudine
    Additional relevant MeSH terms:
    HIV Infections
    Zidovudine
    Quinine
    Probenecid

    Study Results

    No Results Posted as of Nov 3, 2021