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Trial NCT00367081

Resource URI: http://static.linkedct.org/resource/trials/NCT00367081
linkedct:brief_title Treatment of Cerebral Toxoplasmosis in HIV/AIDS
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1395>
linkedct:condition <http://static.linkedct.org/resource/condition/13145>
linkedct:condition <http://static.linkedct.org/resource/condition/52>
linkedct:criteria Inclusion Criteria: - 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 Exclusion Criteria: - Sulfa drugs allergy - positive lymphoma cell cytology in CSF - no informed consent by patients or first degreee relatives - CD4 >200
linkedct:description Background: Toxoplasmic encephalitis (TE), caused by Toxoplasma gondii, is common in AIDS patients. TE can result in tissue destruction via massive inflammation and brain abscess formation. METHODS: Randomized controlled trials were performed in AIDS patients to assess which drug regimen was optimally effective for the treatment of TE. AIDS patients with TE were randomly divided into 3 groups that received a 6-week course of either pyrimethamine (50 mg/ day or 100 mg/day) plus sulfadiazine (4 g/day) and folinic acid (25 mg/day) or trimethoprim (10 mg/kg/day) plus sulfamethoxazole (50 mg/kg/day) (TMP-SMX), and results were evaluated with respect to clinical response, mortality, morbidity, and serious adverse events. The primary outcome was defined as death in the first 6-week period. The secondary outcome was successful treatment within 6 weeks without severe adverse events, bone marrow suppression, drug-induced rash, or any other event that caused a change in the treatment regimen. RESULTS: The results from this study showed that in AIDS patients, TE was most successfully treated with the combination of pyrimethamine (50 mg/day) plus sulfadiazidine (4 g/day) and folinic acid (25 mg/day); failure rates were not significantly different among the 3 treatment groups. Conclusions: Available data suggest that of the currently available options, treatment of TE with pyrimethamine at 50 mg/day plus sulfadiazidine at 4 g/day provides the best primary outcome for AIDS patients with TE; however, because this study was terminated prematurely, we suggest that treatment with intravenous TMP-SMX be further evaluated to determine its efficacy.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 16 Years
linkedct:end_date August 2004
linkedct:enrollment 30 (xsd:int)
linkedct:firstreceived_date August 18, 2006
linkedct:id NCT00367081
rdfs:label Trial NCT00367081
linkedct:lastchanged_date July 29, 2007
linkedct:lead_sponsor_agency Rajavithi Hospital
linkedct:location <http://static.linkedct.org/resource/location/123836>
linkedct:nct_id NCT00367081
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Pyrimethamine Plus Sulfadiazine Versus Trimethoprim Plus Sulfamethoxazole for Treatment of Toxoplasmic Encephalitis in AIDS Patients: A Randomized Controlled Trial.
linkedct:org_study_id RVH-CTR_001
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/56504>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2694>
foaf:page <http://clinicaltrials.gov/show/NCT00367081>
linkedct:phase Phase 4
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/21038>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/7276>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/30053>
linkedct:source Rajavithi Hospital
linkedct:start_date May 2003
linkedct:study_design Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct: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
rdf:type linkedct:trials
linkedct:verification_date July 2007