Treatment of Cerebral Toxoplasmosis in HIV/AIDS

AIDS Clinical Trial

Official title:

Pyrimethamine Plus Sulfadiazine Versus Trimethoprim Plus Sulfamethoxazole for Treatment of Toxoplasmic Encephalitis in AIDS Patients: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367081
• Other study ID #: RVH-CTR_001
• Status: Completed
• Phase: Phase 4
• First received: August 18, 2006
• Last updated: July 29, 2007
• Start date: May 2003
• Est. completion date: August 2004

Study information

• Verified date: July 2007
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS
• Encephalitis
• Toxoplasmic Encephalitis

Intervention

Drug:
• TMX-SMX (Bactrim(R))

• Pyrimethamine plus Sulfadiazine plus leucoverin

Locations

Country	Name	City	State
Thailand	Chiang Mai University hospital (2003-2004)	Chiang Mai

Sponsors (2)

Lead Sponsor	Collaborator
Rajavithi Hospital	Chiang Mai University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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 A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate
Secondary	Complete medication rate