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Cerebral Toxoplasmosis and AIDS (TOXODFA)

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ClinicalTrials.gov Identifier: NCT00803621
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Study Description
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Brief Summary:

With a HIV incidence much higher in the DFA than in European French territory, this disease is a major public health problem in these areas, especially in French Guiana.

Cerebral toxoplasmosis is a priority among the opportunistic infections in AIDS patients from the DFA because of its frequency (French West Indies) and of its lethality (French Guiana).

The diagnosis of cerebral toxoplasmosis may be difficult because based only on presumptive clinical and radiological features. The response to specific antitoxoplasmic therapy confirms a posteriori the diagnosis.

In reference to the data collected by the Biological Resource Centre Toxoplasma, in particular in French Guiana, we think that T. gondii strains reactivating in AIDS patients from DFA are genetically different from those reactivating in AIDS patients from Europe, with an increased capacity for dissemination via peripheral blood in the first ones. This more frequent or more prolonged parasitemia could facilitate the diagnosis of cerebral toxoplasmosis by PCR test from peripheral blood samples in AIDS patients from the French departments of America.


Condition or disease Intervention/treatment
Cerebral Toxoplasmosis AIDS Other: Toxoplasma PCR assay

Study Design
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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Toxoplasmosis and AIDS in the French Departments of America (DFA). Diagnostic Contribution of a PCR Assay and Genetic Diversity of Toxoplasma Gondii.
Study Start Date : June 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toxoplasmosis

Groups and Cohorts
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Intervention Details:
  • Other: Toxoplasma PCR assay
    Toxoplasma PCR assay

Outcome Measures
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Secondary Outcome Measures :
  1. Isolation, genetic typing and storage of T. gondii strains collected among AIDS patients with cerebral toxoplasmosis from the DFA. [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
AIDS patients from the French West Indies and French Guiana having clinical and radiological suspicion of cerebral toxoplasmosis
Criteria

Inclusion Criteria:

  • Adult patient (> 18 years)
  • Patient being informed and accepting to participate in the study with signature of informed consent
  • HIV positive serology
  • Clinical and radiological suspicion of cerebral toxoplasmosis justifying the start of specific antitoxoplasmic therapy

Exclusion Criteria:

  • Protected patient
  • Patient uncovered by social insurance
  • Specific antitoxoplasmic therapy already initiated since 72h or more
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803621


Locations
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France
Service des Maladies Infectieuses - CHU de Pointe à Pitre
Pointe À Pitre, Guadeloupe, France
Services Maladies Infectieuses et Tropicales- CHU Fort-de-France
Fort-de-France, France
Dermatologie et CISIH- CH Andrée Rosemon
Guyane-Française, France
Maladies Infectieuses et Tropicales - CH Andrée Rosemon
Guyane-Française, France
Médecine- CH Ouest Guyanais
Guyane-Français, France
Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Study Director: Daniel AJZENBERG, PharmD, PhD CHU Limoges
More Information
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Publications of Results:

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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00803621    
Other Study ID Numbers: I07009
First Posted: December 5, 2008    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: December 2013
Additional relevant MeSH terms:
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Toxoplasmosis, Cerebral
Toxoplasmosis
Coccidiosis
Protozoan Infections
Parasitic Diseases
Brain Abscess
Abscess
Suppuration
 Infection
Central Nervous System Protozoal Infections
Central Nervous System Parasitic Infections
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections