Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine
Quinine sulfate
+ Probenecid
+ Zidovudine
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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).
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location