Status:

COMPLETED

Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Toxoplasmosis, Cerebral

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

PHASE2

Brief Summary

To evaluate the effectiveness of pyrimethamine (given with leucovorin calcium versus placebo (an inactive substance) for the primary prophylaxis (prevention) of cerebral toxoplasmosis in HIV-infected ...

Detailed Description

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...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

May 1 1994

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT00000643

End Date

May 1 1994

Last Update

November 2 2021

Active Locations (24)

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Page 1 of 6 (24 locations)

1

Stanford CRS

Palo Alto, California, United States, 94304

2

Harbor-UCLA Med. Ctr. CRS

Torrance, California, United States, 90502

3

Univ. of Miami AIDS CRS

Miami, Florida, United States, 33136

4

Northwestern University CRS

Chicago, Illinois, United States, 60611