The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient
Oxazepam
+ Zidovudine
Infections transmises par le sang+11
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Benzodiazepines (such as oxazepam) are among the most frequently prescribed class of drugs and are commonly used therapeutically for patients with chronic disease. This study is important because of the potential for toxicity resulting from a reaction between AZT and benzodiazepines and the likelihood of frequent use of the combination of these drugs in patients with HIV infection. Patients are studied to determine oral and intravenous AZT and single oral dose oxazepam pharmacokinetics. Patients then take AZT and oxazepam together to determine if interactions between the drugs occur.
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.8 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 Concurrent Medication: Required: Stable prescribed dosage of zidovudine (AZT), = or > 500 mg/day. Allowed: Prophylaxis for Pneumocystis carinii pneumonia (PCP) with aerosolized pentamidine. Erythropoietin. Patients must be: HIV positive by ELISA and Western blot. Currently taking a stable prescribed dosage of 500 mg/day of zidovudine (AZT). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Allergy to benzodiazepines or a previously documented intolerance to zidovudine (AZT) therapy of = or < 600 mg/day. Significant underlying medical condition that could impair continuous participation in study. Malabsorption syndrome (3 or more loose stools a day for at least 4 weeks associated with an unintentional weight loss of at least 10 percent of body weight). Concurrent Medication: Excluded: Oral contraceptives. Cytotoxic chemotherapy. Ganciclovir. Flucytosine. Probenecid. Opiates. Valproic acid. Sulfa drugs. Sucralfate. Dapsone. Rifampin. Antacids within 2 hours of zidovudine (AZT) dose. Isoniazid. Ketoconazole. Pyrimethamine. Clindamycin. Aspirin. Ibuprofen. Investigational drugs not specifically allowed. Patients with the following are excluded: Allergy to benzodiazepines or a previously documented intolerance to zidovudine (AZT) therapy of = or < 600 mg/day. Significant underlying medical condition that could impair continuous participation in study. Unable to take oral medication reliably. Prior Medication: Excluded within 30 days of study entry: Antiretroviral agents other than zidovudine (AZT).
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 1 site
Palo Alto Veterans Adm Med Ctr / Stanford Univ
Palo Alto, United StatesOuvrir Palo Alto Veterans Adm Med Ctr / Stanford Univ dans Google Maps