Pyrimethamine Pharmacokinetics in HIV Positive Patients Seropositive for Toxoplasma Gondii
Pyrimethamine
+ Leucovorin calcium
+ Zidovudine
Abscess+27
+ Blood-Borne Infections
+ Neuroinflammatory Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.26 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 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.
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 2 locations
Memorial Sloan-Kettering Cancer Ctr.
New York, United StatesOpen Memorial Sloan-Kettering Cancer Ctr. in Google MapsUnc Aids Crs
Chapel Hill, United States