Treatment of Cerebral Toxoplasmosis in HIV/AIDS
Keywords
Abstract
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
Intervention/treatment
Drug: TMX-SMX (Bactrim(R))
Drug: Pyrimethamine plus Sulfadiazine plus leucoverin
Phase
Eligibility Criteria
Ages Eligible for Study | 16 Years To 16 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
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]