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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Patients are hospitalized overnight on three separate occasions. On the first admission, AZT is administered every 4 hours. On the second day, 15 blood samples are taken to determine how fast the AZT enters and is removed from the bloodstr...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 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.
• • Exclusion Criteria
• 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.
• Concurrent Treatment:
• Excluded:
• • Radiation not specifically allowed.
• Patients with the following are excluded:
• • Allergy to probenecid.
• • Any underlying medical condition sufficient, in investigator's opinion, to prevent adequate compliance with study therapy.
• • History of urinary tract urate stones or gout.
• • Becoming acutely ill, unstable, or febrile.