NCT00000666

Brief Summary

To evaluate pyrimethamine as a prophylactic agent against toxoplasmic encephalitis in individuals who are coinfected with HIV and latent Toxoplasma gondii. Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine. Continuous treatment is necessary to prevent recurrence of the disease, but constant use of pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91 amendment, clindamycin arm was discontinued).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

March 1, 1992

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

First QC Date

November 2, 1999

Last Update Submit

October 26, 2012

Conditions

Toxoplasmosis, CerebralHIV Infections

Keywords

ToxoplasmosisAIDS-Related Opportunistic InfectionsPyrimethamineDrug EvaluationEncephalitisAcquired Immunodeficiency Syndrome

Interventions

PyrimethamineDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Required:
  • Prophylactic treatment for Pneumocystis carinii pneumonia with aerosolized pentamidine, dapsone, or trimethoprim / sulfamethoxazole.
  • Allowed:
  • Most medications not specifically excluded.
  • Prior Medication:
  • Allowed:
  • Antivirals.
  • Antiretrovirals.
  • Patients:
  • Must be HIV positive or have an AIDS-defining illness OR be at known risk for HIV infection and have a CD4 cell count \< 200/mm3 and no other known immunosuppressive disease.
  • Must have positive titer for Toxoplasma gondii.
  • Must be or become a patient of a CPCRA physician.
  • May participate in other clinical trials as long as there is no potential activity against Toxoplasma gondii or cross-toxicity among study drugs.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • History of ocular, pulmonary, or central nervous system (CNS) toxicity.
  • CNS lesions.
  • Neurologic deficits except peripheral neuropathy.
  • Mild, moderate, severe, or end-stage AIDS dementia complex. Grade 3 or higher nausea and/or vomiting.
  • Sensitivity to pyrimethamine.
  • Concurrent Medication:
  • Excluded:
  • On-going therapy with clindamycin, fansidar, methotrexate, trimetrexate, spiramycin, azithromycin, clarithromycin, 566C80, and/or sulfa agents other than anti-PCP agents.
  • Patients with the following are excluded:
  • History of ocular, pulmonary, or central nervous system (CNS) toxicity.
  • CNS lesions or history of CNS lesions.
  • Neurologic deficits except peripheral neuropathy.
  • Mild, moderate, severe, or end-stage AIDS dementia complex. Grade 3 or higher nausea and/or vomiting.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Community Consortium of San Francisco

San Francisco, California, 94110, United States

Location

Denver CPCRA / Denver Public Hlth

Denver, Colorado, 802044507, United States

Location

Hill Health Corp

New Haven, Connecticut, 06519, United States

Location

Wilmington Hosp / Med Ctr of Delaware

Wilmington, Delaware, 19899, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

AIDS Research Alliance - Chicago

Chicago, Illinois, 60657, United States

Location

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, 70112, United States

Location

Comprehensive AIDS Alliance of Detroit

Detroit, Michigan, 48201, United States

Location

Henry Ford Hosp

Detroit, Michigan, 48202, United States

Location

North Jersey Community Research Initiative

Newark, New Jersey, 071032842, United States

Location

Addiction Research and Treatment Corp

Brooklyn, New York, 11201, United States

Location

Clinical Directors Network of Region II

New York, New York, 10011, United States

Location

Harlem AIDS Treatment Group / Harlem Hosp Ctr

New York, New York, 10037, United States

Location

Bronx Lebanon Hosp Ctr

The Bronx, New York, 10456, United States

Location

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, 972109951, United States

Location

Richmond AIDS Consortium

Richmond, Virginia, 23298, United States

Location

Related Publications (3)

  • Jacobson MA, Besch CL, Child C, Hafner R, Muth K, Deyton L. Clinical programs for clinical research on AIDS: description of a randomized prospective study of clindamycin versus pyrimethamine for prevention of Toxoplasma gondii infection. Eur J Clin Microbiol Infect Dis. 1991 Mar;10(3):195-8. doi: 10.1007/BF01964462.

    PMID: 1676364BACKGROUND

  • Jacobson MA, Besch CL, Child C, Hafner R, Matts JP, Muth K, Wentworth DN, Deyton L. Toxicity of clindamycin as prophylaxis for AIDS-associated toxoplasmic encephalitis. Community Programs for Clinical Research on AIDS. Lancet. 1992 Feb 8;339(8789):333-4. doi: 10.1016/0140-6736(92)91649-s.

    PMID: 1346413BACKGROUND

  • Jacobson MA, Besch CL, Child C, Hafner R, Matts JP, Muth K, Wentworth DN, Neaton JD, Abrams D, Rimland D, et al. Primary prophylaxis with pyrimethamine for toxoplasmic encephalitis in patients with advanced human immunodeficiency virus disease: results of a randomized trial. Terry Beirn Community Programs for Clinical Research on AIDS. J Infect Dis. 1994 Feb;169(2):384-94. doi: 10.1093/infdis/169.2.384.

    PMID: 8106772BACKGROUND

MeSH Terms

Conditions

Toxoplasmosis, CerebralHIV InfectionsToxoplasmosisAIDS-Related Opportunistic InfectionsEncephalitisAcquired Immunodeficiency Syndrome

Interventions

Pyrimethamine

Condition Hierarchy (Ancestors)

Brain AbscessCentral Nervous System InfectionsInfectionsCentral Nervous System Protozoal InfectionsCentral Nervous System Parasitic InfectionsParasitic DiseasesCoccidiosisProtozoan InfectionsAbscessSuppurationBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsNeuroinflammatory DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

PyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jacobson M

    STUDY CHAIR

  • Besch CL

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

March 1, 1992

Last Updated

October 29, 2012

Record last verified: 2012-10

Locations

US(16)