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Clinical Trials

MainTitle

Treatment of Cerebral Toxoplasmosis in HIV/AIDS

This study has been completed
Sponsor
Rajavithi Hospital

Collaborator
Chiang Mai University

Information provided by (Responsible Party)
Rajavithi Hospital
ClinicalTrials.gov Identifier
NCT00367081

First received: August 18, 2006
Last updated: July 29, 2007
Last Verified: July 2007
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
Toxoplasmic Encephalitis
AIDS

Drug : TMX-SMX (Bactrim(R))
Drug : Pyrimethamine plus Sulfadiazine plus leucoverin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Pyrimethamine Plus Sulfadiazine Versus Trimethoprim Plus Sulfamethoxazole for Treatment of Toxoplasmic Encephalitis in AIDS Patients: A Randomized Controlled Trial.

Further study details as provided by Rajavithi Hospital:

Primary Outcome Measures

  • Survival rate
Secondary Outcome Measures:
  • Complete medication rate

Enrollment: 30
Study Start Date: May 2003
Study Completion Date: August 2004

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.

Eligibility

Eligibility

Ages Eligible for Study: 16 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367081

Locations

Thailand
Chiang Mai University hospital (2003-2004)
Chiang Mai, Thailand, 50200

Sponsors and Collaborators

Rajavithi Hospital
Chiang Mai University

Investigators

Principal Investigator: Subsai Kongsaengdao, M.D. Rajavithi Hospital
More Information

More Information


Responsible Party: Rajavithi Hospital  
ClinicalTrials.gov Identifier: NCT00367081   History of Changes  
Other Study ID Numbers: RVH-CTR_001  
Study First Received: August 18, 2006  
Last Updated: July 29, 2007  

Keywords provided by Rajavithi Hospital:

Toxoplasmic Encephalitis
AIDS

Additional relevant MeSH terms:
Encephalitis
Pyrimethamine
Sulfadiazine

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.