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Cerebral Toxoplasmosis and AIDS (TOXODFA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00803621
First received: December 2, 2008
Last updated: March 22, 2014
Last verified: December 2013
  Purpose

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 Intervention
Cerebral Toxoplasmosis
AIDS
Other: Toxoplasma PCR assay

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Secondary Outcome Measures:
  • Isolation, genetic typing and storage of T. gondii strains collected among AIDS patients with cerebral toxoplasmosis from the DFA. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: June 2009
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Toxoplasma PCR assay
    Toxoplasma PCR assay
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803621

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
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
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Study Director: Daniel AJZENBERG, PharmD, PhD CHU Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00803621     History of Changes
Other Study ID Numbers: I07009
Study First Received: December 2, 2008
Last Updated: March 22, 2014
Health Authority: France: Direction Générale de la Santé

Additional relevant MeSH terms:
Toxoplasmosis
Toxoplasmosis, Cerebral
Abscess
Brain Abscess
Brain Diseases
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Parasitic Infections
Central Nervous System Protozoal Infections
Coccidiosis
Infection
Nervous System Diseases
Parasitic Diseases
Protozoan Infections
Suppuration

ClinicalTrials.gov processed this record on November 25, 2014