Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients

HIV Infections Clinical Trial

— ANRS 2H  

Official title:

Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039220
• Other study ID #: 2009-AO1115-52
• Status: Completed
• Phase: N/A
• First received: December 22, 2009
• Last updated: April 27, 2017
• Start date: December 2009
• Est. completion date: November 2010

Study information

• Verified date: February 2011
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1266
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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.

Exclusion Criteria:

• patients for whom a H1N1v influenza syndrome can be informed at the beginning of the study.

• Under protection(saving) of justice

Related Conditions & MeSH terms

• HIV Infections
• Influenza
• Influenza, Human

Intervention

Biological:
• naso-pharyngeal swab
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.

Locations

Country	Name	City	State
France	34 ANRS center	Paris + region of country

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious forms (see definition above) identified by any clinical site or hospitalisation unit-Controls: Patients of the randomly selected sample (see survey sampling).
Secondary	Exhaustivity check: The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.

External Links

•   (legal sponsor's website)