A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection
Completed · Not applicable
Conditions studied: Toxoplasmosis, Cerebral, HIV Infections
In brief
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 of illness and death in AIDS patients. Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine. Continuous treatment is necessary to prevent recurrence of the disease, but constant use of pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91 amendment, clindamycin arm was discontinued).
Key facts
- Study ID
- NCT00000666
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 600
- Expected to finish
- 1992-03-01
- Last updated by the study team
- 2012-10-29
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Community Consortium of San Francisco — San Francisco, California, United States
- Denver CPCRA / Denver Public Hlth — Denver, Colorado, United States
- Hill Health Corp — New Haven, Connecticut, United States
- Wilmington Hosp / Med Ctr of Delaware — Wilmington, Delaware, United States
- AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
- AIDS Research Alliance - Chicago — Chicago, Illinois, United States
- Louisiana Comm AIDS Rsch Prog / Tulane Univ Med — New Orleans, Louisiana, United States
- Comprehensive AIDS Alliance of Detroit — Detroit, Michigan, United States
- Henry Ford Hosp — Detroit, Michigan, United States
- North Jersey Community Research Initiative — Newark, New Jersey, United States
- Addiction Research and Treatment Corp — Brooklyn, New York, United States
- Clinical Directors Network of Region II — New York, New York, United States
- Harlem AIDS Treatment Group / Harlem Hosp Ctr — New York, New York, United States
- Bronx Lebanon Hosp Ctr — The Bronx, New York, United States
- Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
- Richmond AIDS Consortium — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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