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A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Toxoplasmosis, Cerebral; HIV Infections

Intervention: Pyrimethamine (Drug)

Phase: N/A

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Jacobson M, Study Chair
Besch CL, Study Chair

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 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).

Clinical Details

Official title: A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection

Study design: Intervention Model: Parallel Assignment, Primary Purpose: Prevention

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 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). 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.

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Community Consortium of San Francisco, San Francisco, California 94110, United States

Denver CPCRA / Denver Public Hlth, Denver, Colorado 802044507, United States

Hill Health Corp, New Haven, Connecticut 06519, United States

Wilmington Hosp / Med Ctr of Delaware, Wilmington, Delaware 19899, United States

AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States

AIDS Research Alliance - Chicago, Chicago, Illinois 60657, United States

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans, Louisiana 70112, United States

Comprehensive AIDS Alliance of Detroit, Detroit, Michigan 48201, United States

Henry Ford Hosp, Detroit, Michigan 48202, United States

North Jersey Community Research Initiative, Newark, New Jersey 071032842, United States

Bronx Lebanon Hosp Ctr, Bronx, New York 10456, United States

Addiction Research and Treatment Corp, Brooklyn, New York 11201, United States

Clinical Directors Network of Region II, New York, New York 10011, United States

Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York, New York 10037, United States

Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon 972109951, United States

Richmond AIDS Consortium, Richmond, Virginia 23298, United States

Additional Information

Related publications:

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.

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.

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.


Last updated: October 26, 2012

Page last updated: August 23, 2015

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