Treatment of Cerebral Toxoplasmosis in HIV/AIDS
Primary Purpose
Toxoplasmic Encephalitis, AIDS
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
TMX-SMX (Bactrim(R))
Pyrimethamine plus Sulfadiazine plus leucoverin
Sponsored by
About this trial
This is an interventional treatment trial for Toxoplasmic Encephalitis focused on measuring Toxoplasmic Encephalitis, AIDS
Eligibility 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
Sites / Locations
- Chiang Mai University hospital (2003-2004)
Outcomes
Primary Outcome Measures
Survival rate
Secondary Outcome Measures
Complete medication rate
Full Information
NCT ID
NCT00367081
First Posted
August 18, 2006
Last Updated
July 29, 2007
Sponsor
Rajavithi Hospital
Collaborators
Chiang Mai University
1. Study Identification
Unique Protocol Identification Number
NCT00367081
Brief Title
Treatment of Cerebral Toxoplasmosis in HIV/AIDS
Official Title
Pyrimethamine Plus Sulfadiazine Versus Trimethoprim Plus Sulfamethoxazole for Treatment of Toxoplasmic Encephalitis in AIDS Patients: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rajavithi Hospital
Collaborators
Chiang Mai University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxoplasmic Encephalitis, AIDS
Keywords
Toxoplasmic Encephalitis, AIDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
TMX-SMX (Bactrim(R))
Intervention Type
Drug
Intervention Name(s)
Pyrimethamine plus Sulfadiazine plus leucoverin
Primary Outcome Measure Information:
Title
Survival rate
Secondary Outcome Measure Information:
Title
Complete medication rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subsai Kongsaengdao, M.D.
Organizational Affiliation
Rajavithi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiang Mai University hospital (2003-2004)
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
17517949
Citation
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.
Results Reference
result
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Treatment of Cerebral Toxoplasmosis in HIV/AIDS
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