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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000670
First received: November 2, 1999
Last updated: March 15, 2012
Last verified: March 2012

November 2, 1999
March 15, 2012
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Complete list of historical versions of study NCT00000670 on ClinicalTrials.gov Archive Site
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Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks
Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks

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.

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 bloodstream (pharmacokinetics). On the second day, after all the blood specimens have been collected, patient starts taking probenecid by mouth every 8 hours, and is discharged from the research unit. The AZT dose is then taken every 8 hours. One week later and again 3 weeks after that, patient is readmitted overnight and the blood sampling to measure AZT levels is repeated. AMENDED: 8 additional patients will be enrolled using the same doses of AZT but a lower dose of probenecid.

Interventional
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Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Probenecid
  • Drug: Zidovudine
Not Provided
Wong SL, Hedaya MA, Sawchuk RJ. Competitive inhibition of zidovudine clearance by probenecid during continuous coadministration. Pharm Res. 1992 Feb;9(2):228-35.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 1989
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000670
ACTG 107, 11082
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: BG Petty
Study Chair: DM Kornhauser
Study Chair: PS Lietman
Study Chair: JG Bartlett
National Institute of Allergy and Infectious Diseases (NIAID)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP