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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Probenecid
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Probenecid, Drug Evaluation, Drug Interactions, Acquired Immunodeficiency Syndrome, Zidovudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCD Med Ctr
  • Johns Hopkins Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 26, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000670
Brief Title
Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks
Official Title
Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1989 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
Detailed 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Probenecid, Drug Evaluation, Drug Interactions, Acquired Immunodeficiency Syndrome, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
16 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Probenecid
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BG Petty
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
DM Kornhauser
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
PS Lietman
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
JG Bartlett
Official's Role
Study Chair
Facility Information:
Facility Name
UCD Med Ctr
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1553347
Citation
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.
Results Reference
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Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks

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