NCT00004317 is a Phase 4 clinical trial of Leucovorin calcium in Toxoplasmosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT00004317?

NCT00004317 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT00004317?

Interventions in NCT00004317: Leucovorin calcium, Pyrimethamine, Spiramycin, Sulfadiazine.

What condition does NCT00004317 study?

NCT00004317 studies Toxoplasmosis.

Is NCT00004317 still recruiting?

NCT00004317 is currently recruiting now. Last updated 13 May 2009.

Last reviewed 2009-05-13 · How we verify

NCT00004317

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase IV Randomized Study of Pyrimethamine, Sulfadiazine, and Leucovorin Calcium for Congenital Toxoplasmosis

Recruiting now Phase 4 Last updated 13 May 2009

What this trial tests

Phase 4 trial testing Leucovorin calcium in Toxoplasmosis in 600 participants. Currently enrolling.

Timeline

1 July 2000

Primary endpoint
1 December 2030

1 December 2030

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	600
Start date	1 July 2000
Primary completion	1 December 2030
Estimated completion	1 December 2030
Sites	1 location across United States

Drugs / interventions tested

Leucovorin calcium — full drug profile →
Pyrimethamine — full drug profile →
Spiramycin (SPIRAMYCIN) — full drug profile →
Sulfadiazine (SULFADIAZINE) — full drug profile →

Conditions studied

Toxoplasmosis — all drugs for Toxoplasmosis →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Eligibility, any sex, with Toxoplasmosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Persistent motor abnormality
Time frame: At pre-specified time points
Vision
Time frame: At pre-specified time points
Hearing
Time frame: At pre-specified time points
New chorioretinal lesion
Time frame: At pre-specified time points
IQ less than 70
Time frame: At pre-specified time points
Decrease in IQ of greater than or equal to 15 points
Time frame: At pre-specified time points

Sponsor's own description

RATIONALE: Congenital toxoplasmosis is an infection caused by the parasitic organism Toxoplasma gondii, and it may be passed from an infected mother to her unborn child. The mother may have mild symptoms or no symptoms; the fetus, however, may experience damage to the eyes, nervous system, skin, and ears. The newborn may have a low birth weight, enlarged liver and spleen, jaundice, anemia, petechiae, and eye damage. Giving the antiparasitic drugs pyrimethamine and sulfadiazine is standard treatment for congenital toxoplasmosis, but it is not yet known which regimen of pyrimethamine is most effective for the disease. PURPOSE: Randomized phase IV trial to determine which regimen of pyrimethamine is most effective when combined with sulfadiazine and leucovorin in treating patients who have congenital toxoplasmosis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Prematurity and severity are associated with Toxoplasma gondii alleles (NCCCTS, 1981-2009).
McLeod R, Boyer KM, Lee D, Mui E, et al · · 2012 · cited 116× · PMID 22499837 · DOI 10.1093/cid/cis258

Verify or expand the search:

Other trials of Leucovorin calcium

Trials testing the same drug.

NCT05610163 — Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Cour · Phase 2 · active not recruiting
NCT05148195 — A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors · Phase 2 · terminated
NCT04097444 — CAPOXIRI+Bevacizumab vs. FOLFOXIRI+Bevacizumab for mCRC · Phase 2 · unknown

Other recruiting trials for Toxoplasmosis

Currently open trials in the same condition.

NCT06305468 — Prognosis of Disseminated and Cerebral Toxoplasmosis Hospitalized in Intensive Care in the Era of PCR Diagnosis · recruiting

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

NCT07216794 — Small Trial of Alendronate Impact on the Reservoir of HIV · Phase 2 · not yet recruiting
NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) · Phase 1 · not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00004317 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 13 May 2009

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00004317.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing