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| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | November 2, 1999 | ||||||||||||||||
| Last Updated Date | August 19, 2008 | ||||||||||||||||
| Start Date ICMJE | |||||||||||||||||
| Primary Completion Date | |||||||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||||||
| Change History | Complete list of historical versions of study NCT00000670 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks | ||||||||||||||||
| Official Title ICMJE | Safety and Tolerance of Zidovudine With Probenecid and the Effect of Probenecid on Zidovudine Pharmacokinetics Over Four Weeks | ||||||||||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Design ICMJE | Treatment, Open Label, Pharmacokinetics Study | ||||||||||||||||
| Condition ICMJE | HIV Infections | ||||||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||||||||||
| Publications * | Wong SL, Hedaya MA, Sawchuk RJ. Competitive inhibition of zidovudine clearance by probenecid during continuous coadministration. Pharm Res. 1992 Feb;9(2):228-35. | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Enrollment ICMJE | 16 | ||||||||||||||||
| Completion Date | |||||||||||||||||
| Primary Completion Date | |||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Concurrent Treatment: Allowed:
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:
Concurrent Medication: Excluded:
Concurrent Treatment: Excluded:
Patients with the following are excluded:
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| Gender | Both | ||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT ID ICMJE | NCT00000670 | ||||||||||||||||
| Responsible Party | |||||||||||||||||
| Study ID Numbers ICMJE | ACTG 107 | ||||||||||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||||||
| Collaborators ICMJE | |||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||||||
| Verification Date | August 1991 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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