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Sponsored by: |
Glaxo Wellcome |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002198 |
The purpose of this study is to see how the body processes 1592U89 and ethanol (pure grain alcohol) when they are given together.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Abacavir sulfate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Study to Investigate Whether There is a Pharmacokinetic Interaction Between 1592U89 and Ethanol Following Their Co-Administration to HIV-Infected Subjects. |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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).
Study ID Numbers: | 238F, CNAA 1010 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002198 |
Health Authority: | United States: Food and Drug Administration |
Drug Interactions Antiviral Agents Ethanol abacavir |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Abacavir Retroviridae Infections Immunologic Deficiency Syndromes Ethanol |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Physiological Effects of Drugs Central Nervous System Depressants Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Infective Agents, Local Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Central Nervous System Agents Nucleic Acid Synthesis Inhibitors |