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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 2, 1999 | ||||
| Last Updated Date | July 11, 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 NCT00000706 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine | ||||
| Official Title ICMJE | Influence of Probenecid and Quinine on the Pharmacokinetics of Azidothymidine | ||||
| Brief Summary | Part I studies the effect of quinine on how zidovudine (AZT) is used by the body and eliminated through the kidneys in HIV infected patients. Part II studies the effect of probenecid and quinine on the same aspects. Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT needed for treatment. |
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| Detailed Description | Because AZT leaves the bloodstream quickly, patients must take the drug frequently to keep adequate amounts in their bodies. Probenecid and quinine may slow down the rate at which AZT leaves the body. Therefore, taking these drugs along with AZT may reduce the amount of AZT needed for treatment. In part I, four patients who are now receiving AZT at the usual dose take part in pharmacokinetic studies (how much of the drug enters the blood stream, what happens to the drug in the body, and how it leaves the body) of AZT defined after a dose while at steady state and then again after a new steady state has been reached following the addition of quinine sulfate. Part II studies the pharmacokinetics of AZT in eight patients receiving AZT at 1 of 2 doses and then at the lower dose of AZT plus probenecid with or without quinine. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Kornhauser DM, Petty BG, Hendrix CW, Woods AS, Nerhood LJ, Bartlett JG, Lietman PS. Probenecid and zidovudine metabolism. Lancet. 1989 Aug 26;2(8661):473-5. | ||||
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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 | 12 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria Patients must:
Allowed:
Exclusion Criteria Co-existing Condition: Patients with any of the following conditions are excluded:
Concurrent Medication: Excluded: - Other drugs that might influence the metabolism or renal excretion of zidovudine (AZT). |
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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 | NCT00000706 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | ACTG 027 | ||||
| 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 | October 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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