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Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine



Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine

For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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).
Total Enrollment: 12

Location and Contact Information:

Overall Study Official:
KornhauserD,  Study Chair, 

Johns Hopkins Hosp
Baltimore,  Maryland,  21287
United States
 


Additional Information:
Study ID Numbers:  ACTG 027; 
Study Start Date: 
Record last reviewed: October 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000706

Other Hiv Infections Studies:
1. A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Volunteers to Evaluate Accelerated Vaccine Schedules

2. Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients With Early HIV Infection

3. HIV Infection in Homosexual and Bisexual Men

4. A Study of Retrovir in the Treatment of Psoriasis in HIV-Positive Patients

5. A Study of Abacavir Plus Indinavir Sulfate Plus Efavirenz in HIV-Infected Patients

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