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Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine

NCT ID: NCT00000706

Last Updated: 2021-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Completion Date

1988-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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Quinine Probenecid Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Quinine sulfate

Intervention Type DRUG

Probenecid

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kornhauser D

Role: STUDY_CHAIR

Locations

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Johns Hopkins Hosp

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/s0140-6736(89)92087-4.

Reference Type BACKGROUND
PMID: 2570186 (View on PubMed)

Other Identifiers

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11003

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 027

Identifier Type: -

Identifier Source: org_study_id