Cerebral Toxoplasmosis and AIDS (TOXODFA)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:

Other: Toxoplasma PCR assay
Toxoplasma PCR assay

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Study Director:	Daniel AJZENBERG, PharmD, PhD	CHU Limoges

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ajzenberg D, Lamaury I, Demar M, Vautrin C, Cabié A, Simon S, Nicolas M, Desbois-Nogard N, Boukhari R, Riahi H, Dardé ML, Massip P, Dupon M, Preux PM, Labrunie A, Boncoeur MP. Performance Testing of PCR Assay in Blood Samples for the Diagnosis of Toxoplasmic Encephalitis in AIDS Patients from the French Departments of America and Genetic Diversity of Toxoplasma gondii: A Prospective and Multicentric Study. PLoS Negl Trop Dis. 2016 Jun 29;10(6):e0004790. doi: 10.1371/journal.pntd.0004790. eCollection 2016 Jun.

Responsible Party:	University Hospital, Limoges
ClinicalTrials.gov Identifier:	NCT00803621 History of Changes
Other Study ID Numbers:	I07009
First Posted:	December 5, 2008
Last Update Posted:	March 26, 2014
Last Verified:	December 2013

Additional relevant MeSH terms:

Toxoplasmosis; Toxoplasmosis, Cerebral; 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