Treatment of Cerebral Toxoplasmosis in HIV/AIDS

This study has been completed.
Sponsor:
Collaborator:
Chiang Mai University
Information provided by:
Rajavithi Hospital
ClinicalTrials.gov Identifier:
NCT00367081
First received: August 18, 2006
Last updated: July 29, 2007
Last verified: July 2007
  Purpose

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.

Resource links provided by NLM:


Further study details as provided by Rajavithi Hospital:

Primary Outcome Measures:
  • Survival rate

Secondary Outcome Measures:
  • Complete medication rate

Estimated Enrollment: 30
Study Start Date: May 2003
Estimated Study Completion Date: August 2004
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 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367081

Locations
Thailand
Chiang Mai University hospital (2003-2004)
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Rajavithi Hospital
Chiang Mai University
Investigators
Principal Investigator: Subsai Kongsaengdao, M.D. Rajavithi Hospital
  More Information

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 July 28, 2014