Clinical trial NCT00803621: Cerebral Toxoplasmosis and AIDS
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Toxoplasmosis
AIDS
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
measure: Isolation, genetic typing and storage of T. gondii strains collected among AIDS patients with cerebral toxoplasmosis from the DFA.
timeFrame: 3 years
Other outcomes:
Locations:
city: Pointe À Pitre
country: France
facility: Service des Maladies Infectieuses - CHU de Pointe à Pitre
state: Guadeloupe
city: Fort-de-France
country: France
facility: Services Maladies Infectieuses et Tropicales- CHU Fort-de-France
city: Guyane-Française
country: France
facility: Dermatologie et CISIH- CH Andrée Rosemon
city: Guyane-Française
country: France
facility: Maladies Infectieuses et Tropicales - CH Andrée Rosemon
city: Guyane-Français
country: France
facility: Médecine- CH Ouest Guyanais
Study officials:
affiliation: CHU Limoges
name: Daniel AJZENBERG, PharmD, PhD
role: STUDY_DIRECTOR
References:
citation: Ajzenberg D, Lamaury I, Demar M, Vautrin C, Cabie A, Simon S, Nicolas M, Desbois-Nogard N, Boukhari R, Riahi H, Darde 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.