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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Abacavir sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002198

238F

CNAA 1010

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.