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
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