Pyrimethamine Pharmacokinetics in HIV Positive Patients Seropositive for Toxoplasma Gondii
Pyrimethamine
+ Leucovorin calcium
+ Zidovudine
Abcès+27
+ Infections transmises par le sang
+ Maladies neuroinflammatoires
Étude thérapeutique
Résumé
Encephalitis caused by Toxoplasma gondii has emerged as the most frequent cause of focal central nervous system infection in patients with AIDS. Untreated, the encephalitis is fatal. The best treatment for this disease has not been determined. Presently it is standard practice to administer a combination of pyrimethamine and sulfadiazine. Little is known about the pharmacokinetics of pyrimethamine in patients with AIDS receiving AZT. Furthermore, there are reports that patients already exposed to toxoplasmosis may not have uniform absorption of pyrimethamine. Patients receive the study treatment for a total of 22 days. Patients are given an initial dose of pyrimethamine followed by a lower dose given as a single oral daily dose for 21 days. Patients continue to receive AZT at the dose prescribed prior to enrollment in the study. Patients receive leucovorin calcium once a day. Neither the leucovorin calcium nor the AZT are provided through the study.
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.26 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: Allowed: Aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis. Isoniazid not initiated during study period. Methadone maintenance. Required: Stable prescribed dose of zidovudine (AZT) of at least 500 mg/day. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Prior history of toxoplasmic encephalitis. Unable to take oral medication reliably or have a malabsorption syndrome (i.e., 3 or more loose stools/day for at least 4 weeks associated with an unintentional weight loss of = or > 10 percent of body weight). History of sensitivity to the study medications. Concurrent Medication: Excluded: Maintenance therapy for opportunistic infections with macrolides or sulfonamides, immunomodulators, rifampin, amphotericin, dapsone, ganciclovir, antifolates, probenecid, benzodiazepines, nephrotoxins, and experimental cytotoxic chemotherapy. Medications such as aspirin, benzodiazepines, cimetidine, indomethacin, morphine, and sulfonamides should be avoided. Concurrent Treatment: Excluded: Lymphocyte replacement. Patients with the following are excluded: Any medical or social condition that, in the opinion of the investigator, would adversely affect either participation or compliance in the study. Diagnosis of AIDS and febrile and have evidence of another serious opportunistic infection or central nervous system impairment. Prior Medication: Excluded: Maintenance therapy for opportunistic infections with macrolides or sulfonamides, immunomodulators, rifampin, amphotericin, dapsone, ganciclovir, antifolates, probenecid, benzodiazepines, nephrotoxins, and experimental cytotoxic chemotherapy within past 14 days. Prior Treatment: Excluded: Lymphocyte replacement within past 14 days. Patients have the following symptoms and conditions: Laboratory evidence of HIV infection. Serological evidence of exposure to Toxoplasma gondii, but no clinical evidence of active toxoplasmic infection. Able to understand and sign a written informed consent. Either homosexual male or intravenous drug user. Required: Stable prescribed dose of zidovudine (AZT) of at least 500 mg/day for 4 weeks. Intravenous drug abuse.
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 2 sites
Memorial Sloan-Kettering Cancer Ctr.
New York, United StatesOuvrir Memorial Sloan-Kettering Cancer Ctr. dans Google MapsUnc Aids Crs
Chapel Hill, United States