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Treatment of Cerebral Toxoplasmosis in HIV/AIDS

Information source: Rajavithi Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Toxoplasmic Encephalitis; AIDS

Intervention: TMX-SMX (Bactrim(R)) (Drug); Pyrimethamine plus Sulfadiazine plus leucoverin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Rajavithi Hospital

Official(s) and/or principal investigator(s):
Subsai Kongsaengdao, M.D., Principal Investigator, Affiliation: Rajavithi Hospital

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Primary outcome: Survival rate

Secondary outcome: Complete medication rate

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

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Starting date: May 2003
Last updated: July 29, 2007

Page last updated: August 23, 2015

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