NCT00803621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 5, 2019

Status Verified

December 1, 2013

Enrollment Period

3.5 years

First QC Date

December 2, 2008

Last Update Submit

July 2, 2019

Conditions

Outcome Measures

Secondary Outcomes (1)

  • Isolation, genetic typing and storage of T. gondii strains collected among AIDS patients with cerebral toxoplasmosis from the DFA.

    3 years

Interventions

Toxoplasma PCR assay

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

AIDS patients from the French West Indies and French Guiana having clinical and radiological suspicion of cerebral toxoplasmosis

You may qualify if:

  • 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

You may not qualify if:

  • Protected patient
  • Patient uncovered by social insurance
  • Specific antitoxoplasmic therapy already initiated since 72h or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Service des Maladies Infectieuses - CHU de Pointe à Pitre

Pointe à Pitre, Guadeloupe, France

Location

Dermatologie et CISIH- CH Andrée Rosemon

Guyane-Française, Guyane-Française, France

Location

Médecine- CH Ouest Guyanais

Guyane-Français, Guyane-Français, France

Location

Services Maladies Infectieuses et Tropicales- CHU Fort-de-France

Fort-de-France, France

Location

Maladies Infectieuses et Tropicales - CH Andrée Rosemon

Guyane-Française, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Toxoplasmosis, CerebralAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Brain AbscessCentral Nervous System InfectionsInfectionsCentral Nervous System Protozoal InfectionsCentral Nervous System Parasitic InfectionsParasitic DiseasesToxoplasmosisCoccidiosisProtozoan InfectionsAbscessSuppurationBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Daniel AJZENBERG, PharmD, PhD

    CHU Limoges

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 5, 2008

Study Start

June 1, 2009

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

July 5, 2019

Record last verified: 2013-12

Locations