Treatment of Cerebral Toxoplasmosis in HIV/AIDS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2004-08-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Toxoplasmic Encephalitis AIDS

Keywords

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Toxoplasmic Encephalitis AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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TMX-SMX (Bactrim(R))

Intervention Type DRUG

Pyrimethamine plus Sulfadiazine plus leucoverin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Subsai Kongsaengdao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Services Ministry of Public Health of Thailand

Locations

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Chiang Mai University hospital (2003-2004)

Chiang Mai, , Thailand

Site Status

Countries

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Thailand

References

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Kongsaengdao S, Samintarapanya K, Oranratnachai K, Prapakarn W, Apichartpiyakul C. Randomized controlled trial of pyrimethamine plus sulfadiazine versus trimethoprim plus sulfamethoxazole for treatment of toxoplasmic encephalitis in AIDS patients. J Int Assoc Physicians AIDS Care (Chic). 2008 Jan-Feb;7(1):11-6. doi: 10.1177/1545109707301244. Epub 2007 May 21.

Reference Type RESULT

PMID: 17517949 (View on PubMed)

Other Identifiers

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RVH-CTR_001

Identifier Type: -

Identifier Source: org_study_id