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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| 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 NCT00002198 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients |
| Official Title ICMJE | A Study to Investigate Whether There is a Pharmacokinetic Interaction Between 1592U89 and Ethanol Following Their Co-Administration to HIV-Infected Subjects. |
| Brief Summary | The purpose of this study is to see how the body processes 1592U89 and ethanol (pure grain alcohol) when they are given together. |
| Detailed Description | Patients are randomized to one of the following three regimens: Regimen 1: 1592U89 alone. Regimen 2: pure grain alcohol diluted in orange juice. Regimen 3: 1592U89 plus pure grain alcohol diluted in orange juice. Treatment is administered weekly for 3 weeks. |
| Study Phase | Phase I |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Open Label |
| Condition ICMJE | HIV Infections |
| Intervention ICMJE | Drug: Abacavir sulfate |
| Study Arms / Comparison Groups | |
| Publications * | |
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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 | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Patients must have:
Prior Medication: Allowed: Local treatment for Kaposi's sarcoma. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Malabsorption syndrome or other GI dysfunction which may interfere with drug absorption. Concurrent Medication: Excluded:
Concurrent Treatment: Excluded: Radiation therapy. Patients with the following prior conditions are excluded:
Prior Medication: Excluded:
Prior Treatment: Excluded: Radiation therapy within 6 weeks prior to study drug administration. 1. Regular weekly alcohol intake of more than 21 units (a unit is equal to 1/2 pint beer or 1 glass of wine or 1 oz of liquor).
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| Gender | Both |
| Ages | 18 Years to 55 Years |
| 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 | NCT00002198 |
| Responsible Party | |
| Study ID Numbers ICMJE | 238F, CNAA 1010 |
| Study Sponsor ICMJE | Glaxo Wellcome |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | August 1997 |
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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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