The purpose of this study is to see how the body processes 1592U89 and ethanol (pure grain
alcohol) when they are given together.
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.
- 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
- 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.
Local treatment for Kaposi's sarcoma.
Patients with the following symptoms and conditions are excluded:
Malabsorption syndrome or other GI dysfunction which may interfere with drug absorption.
- 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.
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
- Participation in another research study within the past month.
- Cytotoxic chemotherapeutic agents within six weeks prior to study drug
- 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.
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