Status:
COMPLETED
A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Toxoplasmosis, Cerebral
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
NA
Brief Summary
To evaluate pyrimethamine as a prophylactic agent against toxoplasmic encephalitis in individuals who are coinfected with HIV and latent Toxoplasma gondii. Toxoplasmic encephalitis is a major cause o...
Detailed Description
Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine. Continuous treatment is n...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
March 1 1992
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00000666
End Date
March 1 1992
Last Update
October 29 2012
Active Locations (16)
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1
Community Consortium of San Francisco
San Francisco, California, United States, 94110
2
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 802044507
3
Hill Health Corp
New Haven, Connecticut, United States, 06519
4
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States, 19899