A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection
Toxoplasmosis, Cerebral, HIV Infections
About this trial
This is an interventional prevention trial for Toxoplasmosis, Cerebral focused on measuring Toxoplasmosis, AIDS-Related Opportunistic Infections, Pyrimethamine, Drug Evaluation, Encephalitis, Acquired Immunodeficiency Syndrome
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Required: Prophylactic treatment for Pneumocystis carinii pneumonia with aerosolized pentamidine, dapsone, or trimethoprim / sulfamethoxazole. Allowed: Most medications not specifically excluded. Prior Medication: Allowed: Antivirals. Antiretrovirals. Patients: Must be HIV positive or have an AIDS-defining illness OR be at known risk for HIV infection and have a CD4 cell count < 200/mm3 and no other known immunosuppressive disease. Must have positive titer for Toxoplasma gondii. Must be or become a patient of a CPCRA physician. May participate in other clinical trials as long as there is no potential activity against Toxoplasma gondii or cross-toxicity among study drugs. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: History of ocular, pulmonary, or central nervous system (CNS) toxicity. CNS lesions. Neurologic deficits except peripheral neuropathy. Mild, moderate, severe, or end-stage AIDS dementia complex. Grade 3 or higher nausea and/or vomiting. Sensitivity to pyrimethamine. Concurrent Medication: Excluded: On-going therapy with clindamycin, fansidar, methotrexate, trimetrexate, spiramycin, azithromycin, clarithromycin, 566C80, and/or sulfa agents other than anti-PCP agents. Patients with the following are excluded: History of ocular, pulmonary, or central nervous system (CNS) toxicity. CNS lesions or history of CNS lesions. Neurologic deficits except peripheral neuropathy. Mild, moderate, severe, or end-stage AIDS dementia complex. Grade 3 or higher nausea and/or vomiting. Sensitivity to pyrimethamine.
Sites / Locations
- Community Consortium of San Francisco
- Denver CPCRA / Denver Public Hlth
- Hill Health Corp
- Wilmington Hosp / Med Ctr of Delaware
- AIDS Research Consortium of Atlanta
- AIDS Research Alliance - Chicago
- Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
- Comprehensive AIDS Alliance of Detroit
- Henry Ford Hosp
- North Jersey Community Research Initiative
- Bronx Lebanon Hosp Ctr
- Addiction Research and Treatment Corp
- Clinical Directors Network of Region II
- Harlem AIDS Treatment Group / Harlem Hosp Ctr
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
- Richmond AIDS Consortium