HIV InfectionsANRS 2HNCT01039220
Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients
A study testing naso-pharyngeal swab in people with HIV Infections and Influenza, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
Trial summary
To estimate the incidence of H1N1v influenza-like illness and to study the risk factors for serious influenza forms during pandemic period in French HIV infected patients. Definitions: Influenza like illness is defined as fever> 37°8C and cough or pharyngalgia. (Centers for Disease Control definition). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Influenza
- What is being tested?
- naso-pharyngeal swab
- How many people
- 1,266 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2009to Nov 2010
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- Able to give written consent
- Covered by French Social Security
- HIV-infected (infection attested by the patient's chart)
- pregnant women
- Control and sample to estimate incidence
Show all 9Show fewer
- Patients followed for their HIV-infection in an ANRS center
- Serious form
- Hospitalization whatever is the service in 14 days consecutive to a H1N1v influenza syndrome such as defined, or death consecutive to a H1N1v influenza syndrome such as defined.
Who cannot join
- patients for whom a H1N1v influenza syndrome can be informed at the beginning of the study.
- Under protection(saving) of justice
Trial locations and contacts
1 site in 1 country.
About this study
To estimate the incidence of H1N1v influenza-like illness and to study the risk factors for serious influenza forms during pandemic period in French HIV infected patients.
- Definitions:
- Influenza like illness is defined as fever> 37°8C and cough or pharyngalgia. (Centers for Disease Control definition).
- Serious forms of influenza-like illness is defined by hospitalization within 14 days onset of symptoms or death attributed to influenza like illness.
- Design:
- Survey sampling for estimating H1N1v influenza-like illness incidence.
- Out of approximately 50 000 patients under follow-up in one of the 40 ANRS centres, a sub-group will be selected by random sampling. Sampling will be stratified by centre and sampling fraction per site will vary in order to select 60 to 80 patients for this study per site. A total of 2500 to 3000 patients will be selected to allow for estimating the incidence of H1N1v influenza-like illness with an adequate precision.
Read more
Selected patients will be asked to contact the clinical staff on site as soon as any influenza like symptoms appear. In the case of influenza like illness patients are requested to attend to the clinic within 24 hours for physical examination and naso-pharyngeal swab for diagnosis of A(H1N1)v infection.
Nested case-control study for the determination of risk factors for serious forms:
- Cases: Serious forms (see definition above) identified by any clinical site or hospitalisation unit.
- Controls: Patients of the randomly selected sample (see survey sampling above), presenting with influenza-like illness without any criterion for severity.
Exhaustivity check:
The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.
- Conditions
- HIV Infections, Influenza
- Being tested
- naso-pharyngeal swab
- Medical subject headings
- HIV Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naso-pharyngeal swabBiological
Selected patients will be asked to contact the clinical staff on site as soon as any influenza like symptoms appear. In the case of influenza like illness patients are requested to attend to the clinic within 24 hours for physical examination and naso-pharyngeal swab for diagnosis of A(H1N1)v infection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious forms (see definition above) identified by any clinical site or hospitalisation unit-Controls: Patients of the randomly selected sample (see survey sampling).
Secondary outcomes (1)
Exhaustivity check: The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,266 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Investigators
- Genevieve CHENE, Principal investigator, INSERM U897 BORDEAUX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039220
- Sponsor's protocol ID
- 2009-AO1115-52
- Acronym
- ANRS 2H
- Status last verified
- Feb 2011
- First submitted
- 22 Dec 2009
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients
- ClinicalTrials.gov ID
- NCT01039220
- Acronym / sponsor ID
- ANRS 2H / 2009-AO1115-52
- Conditions
- HIV Infections, Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,266 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Study start
- Dec 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 24 Dec 2009 (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.
To estimate the incidence of H1N1v influenza-like illness and to study the risk factors for serious influenza forms during pandemic period in French HIV infected patients.
- Definitions:
- Influenza like illness is defined as fever> 37°8C and cough or pharyngalgia. (Centers for Disease Control definition).
- Serious forms of influenza-like illness is defined by hospitalization within 14 days onset of symptoms or death attributed to influenza like illness.
- Design:
- Survey sampling for estimating H1N1v influenza-like illness incidence.
- Out of approximately 50 000 patients under follow-up in one of the 40 ANRS centres, a sub-group will be selected by random sampling. Sampling will be stratified by centre and sampling fraction per site will vary in order to select 60 to 80 patients for this study per site. A total of 2500 to 3000 patients will be selected to allow for estimating the incidence of H1N1v influenza-like illness with an adequate precision.
Selected patients will be asked to contact the clinical staff on site as soon as any influenza like symptoms appear. In the case of influenza like illness patients are requested to attend to the clinic within 24 hours for physical examination and naso-pharyngeal swab for diagnosis of A(H1N1)v infection.
Nested case-control study for the determination of risk factors for serious forms:
- Cases: Serious forms (see definition above) identified by any clinical site or hospitalisation unit.
- Controls: Patients of the randomly selected sample (see survey sampling above), presenting with influenza-like illness without any criterion for severity.
Exhaustivity check:
The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Able to give written consent
- Covered by French Social Security
- HIV-infected (infection attested by the patient's chart)
- pregnant women
Key exclusion criteria (2 listed)
- patients for whom a H1N1v influenza syndrome can be informed at the beginning of the study.
- Under protection(saving) of justice
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 |
|---|---|---|
| naso-pharyngeal swabSelected patients will be asked to contact the clinical staff on site as soon as any influenza like symptoms appear. In the case of influenza like illness patients are requested to attend to the clinic within 24 hours for physical examination and naso-pharyngeal swab for diagnosis of A(H1N1)v infection. | Biological | – |
Primary outcome
Serious forms (see definition above) identified by any clinical site or hospitalisation unit-Controls: Patients of the randomly selected sample (see survey sampling).
1 secondary outcome
Exhaustivity check: The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.
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 28 Apr 2017.
- (legal sponsor's website)Link provided by the sponsor.
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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.
Genevieve CHENE principal investigator
INSERM U897 BORDEAUX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing naso-pharyngeal swab in people with HIV Infections and Influenza, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site 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 9 inclusion and 2 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 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Serious forms (see definition above) identified by any clinical site or hospitalisation unit-Controls: Patients of the randomly selected sample (see survey sampling).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2017.