Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients
Collecte de données
Abcès+28
+ Infections transmises par le sang
+ Maladies génito-urinaires
Étude de prévention
Résumé
Cerebral toxoplasmosis is one of the most frequently encountered opportunistic infections in the course of AIDS. The mortality (death) rate is estimated to be greater than 50 percent. Pyrimethamine is a drug that appears promising for the primary prevention of cerebral toxoplasmosis in HIV-infected patients. AMENDED: 04-04-91 On the first day of therapy, a loading dose is given. After the first day, patients take pyrimethamine or placebo 3 times a week. Patients also take leucovorin calcium orally three times weekly. Enrollment occurs over approximately 12 months. All patients are followed on study until a common study close-out date and final analysis of the study. It is anticipated that this common close-out will occur when the mean duration of time on study therapy will be 3 years (approximately in January, 1994). ORIGINAL design: On the first day of treatment, patients receive a loading dose of pyrimethamine or placebo, plus of leucovorin calcium. After the first day, patients take pyrimethamine or placebo three times a week. Patients also take folinic acid orally three times weekly. The mean duration of study participation is 3 years.
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.150 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
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 13 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: Allowed: * Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), erythropoietin (Eprex), other agents granted Treatment IND or expanded access status. * Investigational triazoles. * Pentamidine for primary prophylaxis of Pneumocystis carinii pneumonia (PCP). Patients with the following are excluded: * History of cerebral toxoplasmosis or toxoplasmosis infection in any other organ or tissue. * Focal neural abnormalities (except peripheral neuropathy) or mass lesions on a previous computerized tomography (CT) scan or magnetic resonance image (MRI), unless subsequent workup rules out toxoplasmosis, in which case abnormalities must have been stable for at least 2 months. * Known or suspected allergy or severe intolerance to study drugs. Patients must have: * Positive toxoplasma serology. * HIV infection. * Willingness and ability to comply with the protocol and capability of giving written informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Current diagnosis of cerebral toxoplasmosis or toxoplasmosis infection in any other organ or tissue. * Known or suspected allergy or severe intolerance to study drugs. Concurrent Medication: Excluded: * Anticoagulants. Other antifolates, sulfonamides, fansidar, macrolides, 5-fluorouracil, dapsone, or any other agent with known activity against Toxoplasma gondii.
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 24 sites
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, United StatesOuvrir SUNY - Buffalo, Erie County Medical Ctr. dans Google MapsBeth Israel Med. Ctr. (Mt. Sinai)
New York, United StatesNY Univ. HIV/AIDS CRS
New York, United StatesCornell University A2201
New York, United States