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

NCT ID: NCT01039220

Last Updated: 2017-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-11-30

Brief 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.

Conditions

HIV Infections; Influenza

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Responsible Party

French National Agency for Research on AIDS and Viral Hepatitis

Principal Investigators

Genevieve CHENE

Role: PRINCIPAL_INVESTIGATOR

INSERM U897 BORDEAUX

Locations

34 ANRS center

Paris + Region of Country, , France

Countries

France

Related Links

http://www.anrs.fr

(legal sponsor's website)

Other Identifiers

2009-AO1115-52

Identifier Type: -

Identifier Source: org_study_id