Search / Trial NCT00000670

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

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Trial Information

Current as of April 22, 2024

Completed

Keywords

Probenecid Drug Evaluation Drug Interactions Acquired Immunodeficiency Syndrome Zidovudine

Description

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.

Attachments

readout_NCT00000670_2024-04-22.pdf

4.5 MB

NCT00000670_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Baltimore, Maryland, United States

Sacramento, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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