NCT00367081

Brief Summary

Neurological manifestations of Cerebral toxoplasmosis or Toxoplasmic encephalitis (TE) in most advance stage HIV infected patients composed of fever, headache, alteration of consciousness with focal neurological signs/symptoms such as include hemiparesis, cranial nerve palsies, and ataxia. Generalised convulsions, in ¾ of patients. Moreover meningeal irritation sign or herniation sign may be presented as life threatening condition

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2003

Geographic Reach
1 country

1 active site

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 Start

First participant enrolled

May 1, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2006

Completed
Last Updated

July 31, 2007

Status Verified

July 1, 2007

First QC Date

August 18, 2006

Last Update Submit

July 29, 2007

Conditions

Toxoplasmic EncephalitisAIDS

Keywords

Toxoplasmic EncephalitisAIDS

Outcome Measures

Primary Outcomes (1)

  • Survival rate

Secondary Outcomes (1)

  • Complete medication rate

Interventions

TMX-SMX (Bactrim(R))DRUG
Pyrimethamine plus Sulfadiazine plus leucoverinDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • AIDS
  • Age \> 16 years
  • Clinical Diagnosis of Cerebral toxoplasmosis, Toxoplasmic encephalitis
  • Positive serum titer for Toxoplasma gondii or Positive CSF titer for Toxoplasma gondii after treatment within 2 weeks
  • CT scan suspected toxoplasmosis, ring enhancing lesion
  • CD4\<200

You may not qualify if:

  • Sulfa drugs allergy
  • positive lymphoma cell cytology in CSF
  • no informed consent by patients or first degreee relatives
  • CD4 \>200

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiang Mai University hospital (2003-2004)

Chiang Mai, 50200, Thailand

Location

Related Publications (1)

  • Kongsaengdao S, Samintarapanya K, Oranratnachai K, Prapakarn W, Apichartpiyakul C. Randomized controlled trial of pyrimethamine plus sulfadiazine versus trimethoprim plus sulfamethoxazole for treatment of toxoplasmic encephalitis in AIDS patients. J Int Assoc Physicians AIDS Care (Chic). 2008 Jan-Feb;7(1):11-6. doi: 10.1177/1545109707301244. Epub 2007 May 21.

    PMID: 17517949RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

PyrimethamineSulfadiazine

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Subsai Kongsaengdao, M.D.

    Department of Medical Services Ministry of Public Health of Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 18, 2006

First Posted

August 22, 2006

Study Start

May 1, 2003

Study Completion

August 1, 2004

Last Updated

July 31, 2007

Record last verified: 2007-07

Locations

TH(1)