Clinical Trials

MainTitle

Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)


Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00000643

First received: November 2, 1999
Last updated: March 29, 2012
Last Verified: March 2012
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Toxoplasmosis, Cerebral
HIV Infections

Drug : Pyrimethamine
Drug : Leucovorin calcium
Phase 2

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Prevention
Official Title: Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 150
Study Completion Date: May 1994

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 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 on study until a common study close-out date and final analysis of the study. It is anticipated that this common close-out will occur when the mean duration of time on study therapy will be 3 years (approximately in January, 1994).
ORIGINAL design: On the first day of treatment, patients receive a loading dose of pyrimethamine or placebo, plus of leucovorin calcium. After the first day, patients take pyrimethamine or placebo three times a week. Patients also take folinic acid orally three times weekly. The mean duration of study participation is 3 years.

Eligibility

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000643

Locations

United States, California
Stanford CRS
Palo Alto, California, United States, 94304
Harbor-UCLA Med. Ctr. CRS
Torrance, California, United States, 90502
United States, Florida
Univ. of Miami AIDS CRS
Miami, Florida, United States, 33136
United States, Illinois
Northwestern University CRS
Chicago, Illinois, United States, 60611
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, United States
United States, Maryland
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Bmc Actg Crs
Boston, Massachusetts, United States, 02118
United States, Minnesota
University of Minnesota, ACTU
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, United States
Washington U CRS
St Louis, Missouri, United States
United States, New Jersey
NJ Med. School CRS
Newark, New Jersey, United States, 07103
United States, New York
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States, 14215
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States, 10003
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Cornell University A2201
New York, New York, United States, 10021
Memorial Sloan-Kettering Cancer Ctr.
New York, New York, United States, 10021
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 27599
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States, 27710
United States, Ohio
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States, 45267
Case CRS
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Pitt CRS
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: BJ Luft
Study Chair: JL Vilde
More Information

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00000643   History of Changes  
Other Study ID Numbers: ACTG 154  
  11129  
Study First Received: November 2, 1999  
Last Updated: March 29, 2012  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

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

Additional relevant MeSH terms:
HIV Infections
Toxoplasmosis
Toxoplasmosis, Cerebral
Levoleucovorin
Pyrimethamine

ClinicalTrials.gov processed this data on November 22, 2017
This information is provided by ClinicalTrials.gov.