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

NCT ID: NCT00002198

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL

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.

Detailed Description

Patients are randomized to one of the following three regimens:

Regimen 1: 1592U89 alone. Regimen 2: pure grain alcohol diluted in orange juice. Regimen 3: 1592U89 plus pure grain alcohol diluted in orange juice. Treatment is administered weekly for 3 weeks.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Abacavir sulfate

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glaxo Wellcome

INDUSTRY

Sponsor Role: lead

Locations

PPD Development, Inc

Wilmington, North Carolina, United States

Countries

United States

Other Identifiers

CNAA 1010

Identifier Type: -

Identifier Source: secondary_id

238F

Identifier Type: -

Identifier Source: org_study_id