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Treatment of Cerebral Toxoplasmosis in HIV/AIDS

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StatusCompleted
Sponsors
Rajavithi Hospital
Collaborators
Chiang Mai University

Keywords

Abstract

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

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.

Dates

Last Verified: 06/30/2007
First Submitted: 08/17/2006
Estimated Enrollment Submitted: 08/19/2006
First Posted: 08/21/2006
Last Update Submitted: 07/28/2007
Last Update Posted: 07/30/2007
Actual Study Start Date: 04/30/2003
Estimated Study Completion Date: 07/31/2004

Condition or disease

Toxoplasmic Encephalitis
AIDS

Intervention/treatment

Drug: TMX-SMX (Bactrim(R))

Drug: Pyrimethamine plus Sulfadiazine plus leucoverin

Phase

Phase 4

Eligibility Criteria

Ages Eligible for Study 16 Years To 16 Years
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
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

Outcome

Primary Outcome Measures

1. Survival rate [undefined]

Secondary Outcome Measures

1. Complete medication rate [undefined]

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