A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients
A Study to Investigate Whether There is a Pharmacokinetic Interaction Between 1592U89 and Ethanol Following Their Co-Administration to HIV-Infected Subjects.
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
August 1, 1997
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Local treatment for Kaposi's sarcoma.
- Prophylactic treatment for opportunistic infections.
- Patients must have:
- HIV-1 infection.
- CD4+ lymphocyte count \>= 200 cells/microliter within 14 days prior to study drug administration.
- No active diagnosis of AIDS (other than visceral Kaposi's sarcoma) according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition.
- Prior Medication:
- Allowed:
- Local treatment for Kaposi's sarcoma.
You may not qualify if:
- 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:
- Medications that cannot be withheld for 48 hours (24 hours for antiretrovirals) prior to study drug administration and until 12 hours after study drug administration on each dosing day.
- Immunomodulators, such as systemic corticosteroids, interleukins and interferons.
- Cytotoxic chemotherapeutic agents.
- Acute treatment for opportunistic infections.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Patients with the following prior conditions are excluded:
- Documented history of alcoholism.
- History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (1)
PPD Development, Inc
Wilmington, North Carolina, 28412, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1997-08