Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Toxoplasmosis, Cerebral

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

NA

Brief 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 o...

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 n...

Eligibility 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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

March 1 1992

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT00000666

End Date

March 1 1992

Last Update

October 29 2012

Active Locations (16)

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Page 1 of 4 (16 locations)

1

Community Consortium of San Francisco

San Francisco, California, United States, 94110

2

Denver CPCRA / Denver Public Hlth

Denver, Colorado, United States, 802044507

3

Hill Health Corp

New Haven, Connecticut, United States, 06519

4

Wilmington Hosp / Med Ctr of Delaware

Wilmington, Delaware, United States, 19899