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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000666 |
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).
Condition | Intervention |
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Toxoplasmosis, Cerebral HIV Infections |
Drug: Pyrimethamine |
Study Type: | Interventional |
Study Design: | Prevention, Parallel Assignment |
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 |
Estimated Enrollment: | 600 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Prior Medication:
Allowed:
Patients:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
United States, California | |
Community Consortium of San Francisco | |
San Francisco, California, United States, 94110 | |
United States, Colorado | |
Denver CPCRA / Denver Public Hlth | |
Denver, Colorado, United States, 802044507 | |
United States, Connecticut | |
Hill Health Corp | |
New Haven, Connecticut, United States, 06519 | |
United States, Delaware | |
Wilmington Hosp / Med Ctr of Delaware | |
Wilmington, Delaware, United States, 19899 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Illinois | |
AIDS Research Alliance - Chicago | |
Chicago, Illinois, United States, 60657 | |
United States, Louisiana | |
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |
New Orleans, Louisiana, United States, 70112 | |
United States, Michigan | |
Henry Ford Hosp | |
Detroit, Michigan, United States, 48202 | |
Comprehensive AIDS Alliance of Detroit | |
Detroit, Michigan, United States, 48201 | |
United States, New Jersey | |
North Jersey Community Research Initiative | |
Newark, New Jersey, United States, 071032842 | |
United States, New York | |
Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
New York, New York, United States, 10037 | |
Bronx Lebanon Hosp Ctr | |
Bronx, New York, United States, 10456 | |
Clinical Directors Network of Region II | |
New York, New York, United States, 10011 | |
Addiction Research and Treatment Corp | |
Brooklyn, New York, United States, 11201 | |
United States, Oregon | |
Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
Portland, Oregon, United States, 972109951 | |
United States, Virginia | |
Richmond AIDS Consortium | |
Richmond, Virginia, United States, 23298 |
Study Chair: | Jacobson M | |
Study Chair: | Besch CL |
Study ID Numbers: | CPCRA 001 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000666 |
Health Authority: | United States: Federal Government |
Toxoplasmosis AIDS-Related Opportunistic Infections Pyrimethamine |
Drug Evaluation Encephalitis Acquired Immunodeficiency Syndrome |
Pyrimethamine Protozoan Infections Opportunistic Infections Sexually Transmitted Diseases, Viral Toxoplasmosis, Cerebral Acquired Immunodeficiency Syndrome Central Nervous System Diseases Brain Diseases Encephalitis Toxoplasmosis Immunologic Deficiency Syndromes |
Folic Acid Virus Diseases Central Nervous System Infections HIV Infections Abscess AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Suppuration Parasitic Diseases Retroviridae Infections |
Anti-Infective Agents Communicable Diseases Antiprotozoal Agents RNA Virus Infections Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Coccidiosis Nervous System Diseases Brain Abscess Enzyme Inhibitors |
Central Nervous System Viral Diseases Folic Acid Antagonists Infection Pharmacologic Actions Central Nervous System Parasitic Infections Antimalarials Antiparasitic Agents Central Nervous System Protozoal Infections Therapeutic Uses Lentivirus Infections |