- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000670
Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- UCD Med Ctr
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hosp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Investigators
- Study Chair: BG Petty
- Study Chair: DM Kornhauser
- Study Chair: JG Bartlett
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antirheumatic Agents
- Antimetabolites
- Gout Suppressants
- Renal Agents
- Uricosuric Agents
- Zidovudine
- Probenecid
Other Study ID Numbers
- ACTG 107
- 11082 (Registry Identifier: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Zidovudine
-
Glaxo WellcomeUnknownHIV InfectionsUnited States
-
Institut de Recherche pour le DeveloppementEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedHIV Infections | PregnancyThailand
-
Glaxo WellcomeCompleted
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
Glaxo WellcomeCompleted
-
Glaxo WellcomeCompletedHIV Infections | LipodystrophyUnited States
-
Universidad Peruana Cayetano HerediaMerck Sharp & Dohme LLCCompletedHTLV-I Infections | Tropical Spastic ParaparesisPeru
-
University of Colorado, DenverNational Institute of Allergy and Infectious Diseases (NIAID); University of...Completed
-
ViiV HealthcareCompleted
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV InfectionsUnited States, Puerto Rico