A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine
L-697,661
+ Zidovudine
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.27 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Univ of Colorado Health Ctr / Denver Gen Hosp
Denver, United StatesNorthwestern Univ Med School
Chicago, United StatesRush Presbyterian - Saint Luke's Med Ctr
Chicago, United States