Cerebral ToxoplasmosisTOXODFANCT00803621
Cerebral Toxoplasmosis and AIDS
An observational study of Cerebral Toxoplasmosis and AIDS, run by University Hospital, Limoges at 5 sites in France.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Toxoplasmosis, AIDS
- What is being tested?
- Toxoplasma PCR assay
- How many people
- 46 participants
- Where
- 5 sitesFrance
- Study dates
- Jun 2009to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AIDS patients from the French West Indies and French Guiana having clinical and radiological suspicion of cerebral toxoplasmosis
Who may be able to join
- 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
Who cannot join
- Protected patient
- Patient uncovered by social insurance
- Specific antitoxoplasmic therapy already initiated since 72h or more
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Services Maladies Infectieuses et Tropicales- CHU Fort-de-France
Fort-de-France
Médecine- CH Ouest Guyanais
Guyane-Français, Guyane-Français
Dermatologie et CISIH- CH Andrée Rosemon
Guyane-Française, Guyane-Française
Maladies Infectieuses et Tropicales - CH Andrée Rosemon
Guyane-Française
Service des Maladies Infectieuses - CHU de Pointe à Pitre
Pointe à Pitre, Guadeloupe
About this study
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.
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).
Read more
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.
- Conditions
- Cerebral Toxoplasmosis, AIDS
- Being tested
- Toxoplasma PCR assay
- Medical subject headings
- Toxoplasmosis, Cerebral, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toxoplasma PCR assayOther
Toxoplasma PCR assay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startJun 2009
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral ToxoplasmosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel AJZENBERG, PharmD, PhD, Study director, CHU Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803621
- Sponsor's protocol ID
- I07009
- Acronym
- TOXODFA
- Status last verified
- Dec 2013
- First submitted
- 2 Dec 2008
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27355620
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00803621
- Acronym / sponsor ID
- TOXODFA / I07009
- Conditions
- Cerebral Toxoplasmosis, AIDS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AIDS patients from the French West Indies and French Guiana having clinical and radiological suspicion of cerebral toxoplasmosis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Protected patient
- Patient uncovered by social insurance
- Specific antitoxoplasmic therapy already initiated since 72h or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toxoplasma PCR assayToxoplasma PCR assay | Other | – |
Primary outcome
Not reported in the source record.
1 secondary outcome
Isolation, genetic typing and storage of T. gondii strains collected among AIDS patients with cerebral toxoplasmosis from the DFA.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Results publication: PubMed 27355620Ajzenberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel AJZENBERG, PharmD, PhD study director
CHU Limoges
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Toxoplasmosis and AIDS, run by University Hospital, Limoges at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00803621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.