Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks

Completed · Not applicable

Conditions studied: HIV Infections

In brief

To evaluate the interaction of probenecid with zidovudine (AZT). Because AZT is eliminated quickly from the body, it must be taken frequently. A previous study showed that probenecid slowed the elimination of AZT without side effects, but that study lasted only 5 days. This study is to see whether this effect continues for 1 month and whether the continuation of probenecid and AZT is free of side effects over 1 month.

Key facts

Study ID

NCT00000670

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

16

Expected to finish

1989-07-01

Last updated by the study team

2021-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Interferon.
• Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
• Concurrent Treatment:
• Allowed:
• Radiation for skin lesions.
• Patients with symptomatic HIV infection taking zidovudine (AZT) five or six times a day as therapy. Includes patients with AIDS who have history of cytologically confirmed Pneumocystis carinii pneumonia (PCP), patients with advanced AIDS related complex (ARC), and HIV antibody positive patients.
• Patients must be able to give written informed consent.

You may not qualify if…

• Co-existing Condition:
• Patients with the following are excluded:
• Allergy to probenecid.
• Any underlying medical condition sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy.
• History of urinary tract urate stones or gout.
• Becoming acutely ill, unstable, or febrile.
• Concurrent Medication:
• Excluded:
• Methotrexate.
• Antiretroviral drugs.
• Ganciclovir.
• Amphotericin.
• Experimental drugs.
• Isoniazid.
• Pyrazinamide.
• Flucytosine.
• Intravenous pentamidine.
• Dapsone.
• Fansidar.
• Antineoplastic drugs not specifically allowed.
• Trimethoprim / sulfamethoxazole.
• Valproic acid.
• Opiates.
• Rifampin.
• Sulfonylureas.

Where it is running

• UCD Med Ctr — Sacramento, California, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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