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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glaxo Wellcome
• Treatments: Abacavir; Ethanol

Criteria

Inclusion Criteria

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.

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:

• 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:

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).

• Recent change in normal pattern of alcohol usage (e.g., prolonged use followed by > one month abstinence).

• Total abstinence from alcohol use.

• Positive breath alcohol test upon arrival at the study center prior to any dosing day.