Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients (ANRS 2H)
This study has been completed.
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT01039220
First received: December 22, 2009
Last updated: February 10, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infections Influenza |
Biological: naso-pharyngeal swab |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients |
Resource links provided by NLM:
Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:
Primary Outcome Measures:
- Serious forms (see definition above) identified by any clinical site or hospitalisation unit-Controls: Patients of the randomly selected sample (see survey sampling). [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Exhaustivity check: The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources. [ Designated as safety issue: No ]
| Enrollment: | 1266 |
| Study Start Date: | December 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039220
Locations
| France | |
| 34 ANRS center | |
| Paris + region of country, France | |
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
| Principal Investigator: | Genevieve CHENE ... | INSERM U897 BORDEAUX |
More Information
Additional Information:
No publications provided
| Responsible Party: | Name/Official Title: Lucie Marchand/Project manager, French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT01039220 History of Changes |
| Other Study ID Numbers: | 2009-AO1115-52 |
| Study First Received: | December 22, 2009 |
| Last Updated: | February 10, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Influenza, Human Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Orthomyxoviridae Infections Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013