A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine

Inclusion Criteria

Patients must have:

• HIV infection.

Prior Medication: Included:

• Patients in Part 1 must have received no previous zidovudine (AZT) or a stable dose of at least 500 mg/day without evidence of toxicity.
• Patients in Part 2 must have received no previous AZT or = or > 300 mg/day for < 6 consecutive weeks within 1 year prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Acute HIV-related opportunistic infection requiring ongoing treatment.
• Diarrhea defined as 3 or more liquid stools/day for one week.
• Wilson's or Gilbert's disease, porphyria, or other chronic or acute hepatic disease.
• Potentially life-threatening allergic reactions to any of the components of zidovudine.
• Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study.

Concurrent Medication:

Excluded:

• Systemic bronchodilators, acetaminophen, aspirin.

Prior Medication:

Excluded:

• Didanosine (ddI) or dideoxycytidine (ddC) within 14 days prior to entry.
• Immune modulators or investigational drugs within 30 days prior to entry.
• Drugs known to induce hepatocellular enzymes, such as phenobarbital, phenytoin, warfarin, ketoconazole, and oral contraceptives, within 30 days prior to entry.

Patients in Part 2 only:

Excluded:

• Zidovudine within 4 weeks prior to receiving first dose of study drug.

Risk Behavior:

Excluded:

• Patients who the investigator feels would not comply with study requirements.

Patients may not have the following prior conditions:

• Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study.
• Potentially life-threatening allergic reactions to any of the components of zidovudine.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety