Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367081
Status:
COMPLETED
Last Update Posted:
2007-07-31
First Post:
2006-08-18
Brief Title:
Treatment of Cerebral Toxoplasmosis in HIVAIDS
Sponsor:
Rajavithi Hospital
Organization:
Rajavithi Hospital
Study Overview
Official Title:
Pyrimethamine Plus Sulfadiazine Versus Trimethoprim Plus Sulfamethoxazole for Treatment of Toxoplasmic Encephalitis in AIDS Patients A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 signssymptoms 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 mgday plus sulfadiazine 4 gday and folinic acid 25 mgday or trimethoprim 10 mgkgday plus sulfamethoxazole 50 mgkgday 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 mgday plus sulfadiazidine 4 gday and folinic acid 25 mgday 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 mgday plus sulfadiazidine at 4 gday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None