Cerebral Toxoplasmosis and AIDS

AIDS Clinical Trial

— TOXODFA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803621
• Other study ID #: I07009
• Status: Completed
• Start date: June 2009
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AIDS
• Cerebral Toxoplasmosis
• Toxoplasmosis
• Toxoplasmosis, Cerebral

Intervention

Other:
• Toxoplasma PCR assay
Toxoplasma PCR assay

Locations

Country	Name	City	State
France	Services Maladies Infectieuses et Tropicales- CHU Fort-de-France	Fort-de-France
France	Médecine- CH Ouest Guyanais	Guyane-Français
France	Dermatologie et CISIH- CH Andrée Rosemon	Guyane-Française
France	Maladies Infectieuses et Tropicales - CH Andrée Rosemon	Guyane-Française
France	Service des Maladies Infectieuses - CHU de Pointe à Pitre	Pointe À Pitre	Guadeloupe

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

References & Publications (1)

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 Toxoplas — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	Isolation, genetic typing and storage of T. gondii strains collected among AIDS patients with cerebral toxoplasmosis from the DFA.		3 years