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.
Purpose
