Completed

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

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What is being tested

Probenecid

+ Zidovudine
Drug
Who is being recruted

HIV Infections

Over 18 Years
How is the trial designed

Treatment Study

Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 3, 2021
Sourced from a government-validated database.Claim as a partner

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.

Official TitleSafety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 3, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
16 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
UCD Med CtrSacramento, United StatesSee the location
Suspended
Johns Hopkins HospBaltimore, United States

Completed2 Study Centers