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

NCT00000670 | Completed

• 2 other identifiers: ACTG 10711082
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HIV Infections

Keywords

Probenecid; Drug Evaluation; Drug Interactions; Acquired Immunodeficiency Syndrome; Zidovudine

Interventions

Probenecid DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

UCD Med Ctr

Sacramento, California, 95817, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Wong SL, Hedaya MA, Sawchuk RJ. Competitive inhibition of zidovudine clearance by probenecid during continuous coadministration. Pharm Res. 1992 Feb;9(2):228-35. doi: 10.1023/a:1018993524818.

  PMID: 1553347 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Probenecid; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• BG Petty

  STUDY CHAIR

• DM Kornhauser

  STUDY CHAIR

• PS Lietman

  STUDY CHAIR

• JG Bartlett

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: July 1, 1989
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (2)