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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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