Treatment of Cerebral Toxoplasmosis in HIV/AIDS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pyrimethamine Plus Sulfadiazine Versus Trimethoprim Plus Sulfamethoxazole for Treatment of Toxoplasmic Encephalitis in AIDS Patients: A Randomized Controlled Trial.

Conditions
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AIDS, Toxoplasmic Encephalitis

Intervention / Treatment
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* Drug: TMX-SMX (Bactrim(R))
* Drug: Pyrimethamine plus Sulfadiazine plus leucoverin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TMX-SMX (Bactrim(R))|nan|
|Drug: Pyrimethamine plus Sulfadiazine plus leucoverin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete medication rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Toxoplasmic Encephalitis, AIDS