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Trial record 2 of 3 for:    "Toxoplasmosis" | "Sulfamethoxazole"

Treatment of Cerebral Toxoplasmosis in HIV/AIDS

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ClinicalTrials.gov Identifier: NCT00367081
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : July 31, 2007
Sponsor:
Collaborator:
Chiang Mai University
Information provided by:
Rajavithi Hospital

Tracking Information
First Submitted Date  ICMJE August 18, 2006
First Posted Date  ICMJE August 22, 2006
Last Update Posted Date July 31, 2007
Study Start Date  ICMJE May 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2006)
Survival rate
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00367081 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2006)
Complete medication rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Cerebral Toxoplasmosis in HIV/AIDS
Official Title  ICMJE Pyrimethamine Plus Sulfadiazine Versus Trimethoprim Plus Sulfamethoxazole for Treatment of Toxoplasmic Encephalitis in AIDS Patients: A Randomized Controlled Trial.
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
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE
  • Toxoplasmic Encephalitis
  • AIDS
Intervention  ICMJE
  • Drug: TMX-SMX (Bactrim(R))
  • Drug: Pyrimethamine plus Sulfadiazine plus leucoverin
Study Arms  ICMJE Not Provided
Publications * 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. Epub 2007 May 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 20, 2006)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00367081
Other Study ID Numbers  ICMJE RVH-CTR_001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Rajavithi Hospital
Collaborators  ICMJE Chiang Mai University
Investigators  ICMJE
Principal Investigator: Subsai Kongsaengdao, M.D. Rajavithi Hospital
PRS Account Rajavithi Hospital
Verification Date July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP