Treatment of Cerebral Toxoplasmosis in HIV/AIDS
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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
Condition | Intervention | Phase |
---|---|---|
Toxoplasmic Encephalitis AIDS |
Drug: TMX-SMX (Bactrim(R)) Drug: Pyrimethamine plus Sulfadiazine plus leucoverin |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
Official Title: | Pyrimethamine Plus Sulfadiazine Versus Trimethoprim Plus Sulfamethoxazole for Treatment of Toxoplasmic Encephalitis in AIDS Patients: A Randomized Controlled Trial. |
- Survival rate
- Complete medication rate
Estimated Enrollment: | 30 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | August 2004 |
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.
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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Thailand | |
Chiang Mai University hospital (2003-2004) | |
Chiang Mai, Thailand, 50200 |
Principal Investigator: | Subsai Kongsaengdao, M.D. | Rajavithi Hospital |
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Publications:
ClinicalTrials.gov Identifier: | NCT00367081 History of Changes |
Other Study ID Numbers: | RVH-CTR_001 |
Study First Received: | August 18, 2006 |
Last Updated: | July 29, 2007 |
Health Authority: | Thailand: Ministry of Public Health |
Keywords provided by Rajavithi Hospital:
Toxoplasmic Encephalitis AIDS |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Encephalitis Toxoplasmosis, Cerebral Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Central Nervous System Viral Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections Brain Abscess Abscess Suppuration Infection Central Nervous System Protozoal Infections Central Nervous System Parasitic Infections Parasitic Diseases Toxoplasmosis Coccidiosis Protozoan Infections Pyrimethamine Sulfadiazine |
ClinicalTrials.gov processed this record on March 10, 2013