HIV Infections
Conditions
Keywords
Drug Evaluation, Drugs, Investigational, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
Brief 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.
Detailed description
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. Part 1: Twelve patients are randomly assigned to one of two groups. Group 1 patients receive AZT for 7 days, followed by AZT plus L-697,661 with food for 56 days. Group 2 patients receive no drug for 7 days, followed by L-697,661 with food for 56 days. Antipyrine is administered 1 hour prior to study drug on days 8, 22, and 35. Part 2: Fifteen patients receive L-697,661 with food, for 8 weeks. Therapy with L-697,661 may be extended beyond 8 weeks for up to 24 weeks.
Interventions
DRUGL-697,661
DRUGZidovudine
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Merck Sharp & Dohme LLC
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed