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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661.

L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: L 697661; L-697661; Zidovudine

Criteria

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.