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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

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000666
  Purpose

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
Toxoplasmosis, Cerebral
HIV Infections
Drug: Pyrimethamine

MedlinePlus related topics:   AIDS    Encephalitis    Toxoplasmosis   

Drug Information available for:   Pyrimethamine   

U.S. FDA Resources

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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   600

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
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000666

Locations
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

Sponsors and Collaborators

Investigators
Study Chair:     Jacobson M    
Study Chair:     Besch CL    
  More Information


Publications:

Study ID Numbers:   CPCRA 001
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00000666
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Toxoplasmosis  
AIDS-Related Opportunistic Infections  
Pyrimethamine  
Drug Evaluation
Encephalitis
Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on December 03, 2008




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