A Study of 1592U89 and Ethanol When Given Together to HIV-Infected Patients

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to see how the body processes 1592U89 and ethanol (pure grain alcohol) when they are given together.

Key facts

Study ID

NCT00002198

Run by

Glaxo Wellcome

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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.
• History of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs.
• Participation in another research study within the past month.
• Prior Medication:
• Excluded:
• Cytotoxic chemotherapeutic agents within six weeks prior to study drug administration.
• Immunomodulating agents within six weeks prior to study drug administration.
• Treatment with the following within 2 weeks prior to study drug administration:
• acyclovir, carbamazepine, chloramphenicol, ganciclovir, phenytoin, rifampin, sodium valproate, or valacyclovir.
• Prior Treatment:
• Excluded:

Where it is running

• PPD Development, Inc — Wilmington, North Carolina, United States

Full record on ClinicalTrials.gov

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