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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 Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma gondii Infection conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma gondii Infection Clinical research trials and A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma gondii Infection health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma gondii Infection. A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma gondii Infection Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma gondii Infection clinical trial. Subjects frequently get the best healthcare possible for their A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma gondii Infection condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma gondii Infection  A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma gondii Infection
A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma gondii Infection
For Condition: Toxoplasmosis, Cerebral,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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).
Details: 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:
Study Type: Interventional, Prevention, Parallel Assignment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 600
Location and Contact Information:
Overall Study Official:
JacobsonM, Study Chair,
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
United States
Community Consortium of San Francisco
San Francisco, California, 94110
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York City, New York, 10037
United States
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
Richmond AIDS Consortium
Richmond, Virginia, 23298
United States
Clinical Directors Network of Region II
New York City, New York, 10011
United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, 48201
United States
Hill Health Corp
New Haven, Connecticut, 06519
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 972109951
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10456
United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
United States
Additional Information:
Study ID Numbers: CPCRA 001;
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000666
Other Hiv Infections Studies:
1. Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients
2. A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients with AIDS
3. Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis
4. A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients
5. A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS
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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
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