A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection
NCT ID: NCT00000666
Last Updated: 2012-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
600 participants
INTERVENTIONAL
1992-03-31
Brief Summary
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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).
Detailed Description
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Patients are randomized to receive pyrimethamine or placebo three times a week. All patients must be on aerosolized pentamidine, trimethoprim / sulfamethoxazole (T/S), or dapsone for Pneumocystis carinii pneumonia prophylaxis. Patients will be evaluated bi-weekly for the first month and every other month thereafter for at least 24 months.
Conditions
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Keywords
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Study Design
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PARALLEL
PREVENTION
Interventions
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Pyrimethamine
Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Jacobson M
Role: STUDY_CHAIR
Besch CL
Role: STUDY_CHAIR
Locations
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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
Countries
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References
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Jacobson MA, Besch CL, Child C, Hafner R, Muth K, Deyton L. Clinical programs for clinical research on AIDS: description of a randomized prospective study of clindamycin versus pyrimethamine for prevention of Toxoplasma gondii infection. Eur J Clin Microbiol Infect Dis. 1991 Mar;10(3):195-8. doi: 10.1007/BF01964462.
Jacobson MA, Besch CL, Child C, Hafner R, Matts JP, Muth K, Wentworth DN, Deyton L. Toxicity of clindamycin as prophylaxis for AIDS-associated toxoplasmic encephalitis. Community Programs for Clinical Research on AIDS. Lancet. 1992 Feb 8;339(8789):333-4. doi: 10.1016/0140-6736(92)91649-s.
Jacobson MA, Besch CL, Child C, Hafner R, Matts JP, Muth K, Wentworth DN, Neaton JD, Abrams D, Rimland D, et al. Primary prophylaxis with pyrimethamine for toxoplasmic encephalitis in patients with advanced human immunodeficiency virus disease: results of a randomized trial. Terry Beirn Community Programs for Clinical Research on AIDS. J Infect Dis. 1994 Feb;169(2):384-94. doi: 10.1093/infdis/169.2.384.
Other Identifiers
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CPCRA 001
Identifier Type: -
Identifier Source: org_study_id