Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients
2 other identifiers
interventional
150
1 country
24
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 patients. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
24 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
May 1, 1994
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 2, 2021
October 1, 2021
November 2, 1999
October 26, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Stanford CRS
Palo Alto, California, 94304, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, 90502, United States
Univ. of Miami AIDS CRS
Miami, Florida, 33136, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60611, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287, United States
Bmc Actg Crs
Boston, Massachusetts, 02118, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
Washington U CRS
St Louis, Missouri, United States
NJ Med. School CRS
Newark, New Jersey, 07103, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10003, United States
NY Univ. HIV/AIDS CRS
New York, New York, 10016, United States
Cornell University A2201
New York, New York, 10021, United States
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, 10021, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
Unc Aids Crs
Chapel Hill, North Carolina, 27599, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, 27710, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, 45267, United States
Case CRS
Cleveland, Ohio, 44106, United States
Pitt CRS
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (7)
Rousseau F, Pueyo S, Morlat P, Hafner R, Chene G, Leport C, Luft BJ, Miro J, Aubertin J, Salamon R, Vilde JL. Increased risk of toxoplasmic encephalitis in human immunodeficiency virus-infected patients with pyrimethamine-related rash. ANRS 005-ACTG 154 Trial Group. Agence Nationale de Recherche sur le SIDA (ANRS-INSERM) and the NIAID-AIDS Clinical Trials Group. Clin Infect Dis. 1997 Mar;24(3):396-402. doi: 10.1093/clinids/24.3.396.
PMID: 9114191BACKGROUNDLeport C, Chene G, Farinotti R, Ecobichon J-L, Petavin G, Sagardoy G, Morlat P, Hafner R, Luft B, Salamon R, Vilde J-L. Determination of pyrimethamine serum levels in a primary prophylaxis trial for toxoplasmic encephalitis. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:159
BACKGROUNDLeport C, Chene G, Morlat P, Luft BJ, Rousseau F, Pueyo S, Hafner R, Miro J, Aubertin J, Salamon R, Vilde JL. Pyrimethamine for primary prophylaxis of toxoplasmic encephalitis in patients with human immunodeficiency virus infection: a double-blind, randomized trial. ANRS 005-ACTG 154 Group Members. Agence Nationale de Recherche sur le SIDA. AIDS Clinical Trial Group. J Infect Dis. 1996 Jan;173(1):91-7. doi: 10.1093/infdis/173.1.91.
PMID: 8537688BACKGROUNDPueyo S, Salmi LR, Chene G, Leport C, Morlat P, Dequae L, Gregoire V, Hafner R, Vilde JL, Luft BJ, Aubertin J, Salamon R. Survival after AIDS-defining events in patients with < 200 lymphocytes CD4+ x 10(6)/L who are toxoplasmosis antibody positive. ANRS 005/ACTG 154 Trial Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Apr 15;14(5):459-64. doi: 10.1097/00042560-199704150-00010.
PMID: 9170421BACKGROUNDDerouin F, Leport C, Pueyo S, Morlat P, Letrillart B, Chene G, Ecobichon JL, Luft B, Aubertin J, Hafner R, Vilde JL, Salamon R. Predictive value of Toxoplasma gondii antibody titres on the occurrence of toxoplasmic encephalitis in HIV-infected patients. ANRS 005/ACTG 154 Trial Group. AIDS. 1996 Nov;10(13):1521-7. doi: 10.1097/00002030-199611000-00010.
PMID: 8931787BACKGROUNDChene G, Morlat P, Hafner R, Aboulker JP, Luft B, Dormont J, Vilde JL, Salamon R. Intent-to-treat versus on treatment analysis: how to interpret the results of a clinical trial? Experience from ANRS 005/ACTG 154 study. Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:100
BACKGROUNDChene G, Morlat P, Leport C, Hafner R, Dequae L, Charreau I, Aboulker JP, Luft B, Aubertin J, Vilde JL, Salamon R. Intention-to-treat vs. on-treatment analyses of clinical trial data: experience from a study of pyrimethamine in the primary prophylaxis of toxoplasmosis in HIV-infected patients. ANRS 005/ACTG 154 Trial Group. Control Clin Trials. 1998 Jun;19(3):233-48. doi: 10.1016/s0197-2456(97)00145-1.
PMID: 9620807BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
BJ Luft
- STUDY CHAIR
JL Vilde
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
May 1, 1994
Last Updated
November 2, 2021
Record last verified: 2021-10