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| Sponsored by: |
Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002198 |
Purpose
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. |
Eligibility| 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).
Contacts and Locations
More Information
| Study ID Numbers: | 238F, CNAA 1010 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002198 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Interactions Antiviral Agents Ethanol abacavir |
|
Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Central Nervous System Depressants Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases |
Anti-Infective Agents, Local Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Abacavir Retroviridae Infections Ethanol |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Abacavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Ethanol RNA Virus Infections |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Central Nervous System Depressants Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Anti-Infective Agents, Local HIV Infections Sexually Transmitted Diseases Lentivirus Infections Central Nervous System Agents |