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| Sponsor: | 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: | Masking: Open Label Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00002198 History of Changes |
| Other Study ID Numbers: | 238F, CNAA 1010 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Interactions Antiviral Agents Ethanol abacavir |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ethanol Abacavir Anti-Infective Agents, Local |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |