Clincosm LogoSign in Get a demo

TOXODFA: Cerebral Toxoplasmosis and AIDS

Sponsor
University Hospital, Limoges (Other)
Overall Status
Completed
CT.gov ID
NCT00803621
Collaborator
(none)
46
Enrollment
5
Locations
54
Duration (Months)
9.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Other: Toxoplasma PCR assay

Study Design

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 :
Jun 1, 2009
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2013

Outcome Measures

Primary Outcome Measures

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Service des Maladies Infectieuses - CHU de Pointe à Pitre Pointe À Pitre Guadeloupe France
    2 Services Maladies Infectieuses et Tropicales- CHU Fort-de-France Fort-de-France France
    3 Dermatologie et CISIH- CH Andrée Rosemon Guyane-Française France
    4 Maladies Infectieuses et Tropicales - CH Andrée Rosemon Guyane-Française France
    5 Médecine- CH Ouest Guyanais Guyane-Français France

    Sponsors and Collaborators

    • University Hospital, Limoges

    Investigators

    • Study Director: Daniel AJZENBERG, PharmD, PhD, CHU Limoges

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Limoges
    ClinicalTrials.gov Identifier:
    NCT00803621
    Other Study ID Numbers:
    • I07009
    First Posted:
    Dec 5, 2008
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Dec 1, 2013
    Additional relevant MeSH terms:
    Toxoplasmosis
    Toxoplasmosis, Cerebral

    Study Results

    No Results Posted as of Jul 5, 2019