Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine - Tabular View

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

July 11, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000706 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine

Official Title ^ICMJE

Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine

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.

Detailed Description

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Quinine sulfate
Drug: Probenecid
Drug: Zidovudine

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000706

Responsible Party

Study ID Numbers ^ICMJE

ACTG 027

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Kornhauser D

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

October 1991

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