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Treatment of Cerebral Toxoplasmosis in HIV/AIDS

This study has been completed.
Sponsor:
Collaborator:
Chiang Mai University
Information provided by:
Rajavithi Hospital
ClinicalTrials.gov Identifier:
NCT00367081
First received: August 18, 2006
Last updated: July 29, 2007
Last verified: July 2007

August 18, 2006
July 29, 2007
May 2003
Not Provided
Survival rate
Same as current
Complete list of historical versions of study NCT00367081 on ClinicalTrials.gov Archive Site
Complete medication rate
Same as current
Not Provided
Not Provided
 
Treatment of Cerebral Toxoplasmosis in HIV/AIDS
Pyrimethamine Plus Sulfadiazine Versus Trimethoprim Plus Sulfamethoxazole for Treatment of Toxoplasmic Encephalitis in AIDS Patients: A Randomized Controlled Trial.

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Toxoplasmic Encephalitis
  • AIDS
  • Drug: TMX-SMX (Bactrim(R))
  • Drug: Pyrimethamine plus Sulfadiazine plus leucoverin
Not Provided
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 Ill). 2007 May 21; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2004
Not Provided

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00367081
RVH-CTR_001
Not Provided
Not Provided
Rajavithi Hospital
Chiang Mai University
Principal Investigator: Subsai Kongsaengdao, M.D. Rajavithi Hospital
Rajavithi Hospital
July 2007

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