A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine
L-697,661
+ Zidovudine
Infections transmises par le sang+14
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.27 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 5 sites
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