Cerebral Toxoplasmosis and AIDS (TOXODFA)

July 2, 2019 updated by: University Hospital, Limoges

Cerebral Toxoplasmosis and AIDS in the French Departments of America (DFA). Diagnostic Contribution of a PCR Assay and Genetic Diversity of Toxoplasma Gondii.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I07009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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