Search / Trial NCT00000643

Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 07, 2024

Completed

Keywords

Toxoplasmosis Pyrimethamine Leucovorin Drug Evaluation Acquired Immunodeficiency Syndrome Aids Related Complex Brain Diseases

ClinConnect Summary

Cerebral toxoplasmosis is one of the most frequently encountered opportunistic infections in the course of AIDS. The mortality (death) rate is estimated to be greater than 50 percent. Pyrimethamine is a drug that appears promising for the primary prevention of cerebral toxoplasmosis in HIV-infected patients.

AMENDED: 04-04-91 On the first day of therapy, a loading dose is given. After the first day, patients take pyrimethamine or placebo 3 times a week. Patients also take leucovorin calcium orally three times weekly. Enrollment occurs over approximately 12 months. All patients are followed...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), erythropoietin (Eprex), other agents granted Treatment IND or expanded access status.
  • Investigational triazoles.
  • Pentamidine for primary prophylaxis of Pneumocystis carinii pneumonia (PCP).
  • Patients with the following are excluded:
  • History of cerebral toxoplasmosis or toxoplasmosis infection in any other organ or tissue.
  • Focal neural abnormalities (except peripheral neuropathy) or mass lesions on a previous computerized tomography (CT) scan or magnetic resonance image (MRI), unless subsequent workup rules out toxoplasmosis, in which case abnormalities must have been stable for at least 2 months.
  • Known or suspected allergy or severe intolerance to study drugs.
  • Patients must have:
  • Positive toxoplasma serology.
  • HIV infection.
  • Willingness and ability to comply with the protocol and capability of giving written informed consent.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Current diagnosis of cerebral toxoplasmosis or toxoplasmosis infection in any other organ or tissue.
  • Known or suspected allergy or severe intolerance to study drugs.
  • Concurrent Medication:
  • Excluded:
  • Anticoagulants. Other antifolates, sulfonamides, fansidar, macrolides, 5-fluorouracil, dapsone, or any other agent with known activity against Toxoplasma gondii.

Trial Officials

BJ Luft

Study Chair

JL Vilde

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Palo Alto, California, United States

Torrance, California, United States

Miami, Florida, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Minneapolis, Minnesota, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Newark, New Jersey, United States

Buffalo, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Pittsburgh, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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