Clinical Trials

MainTitle

Primary Infection Cohort (PRIMO)

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2017 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Sponsor
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)


Information provided by (Responsible Party)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier
NCT03148964

First received: April 12, 2017
Last updated: May 10, 2017
Last Verified: April 2017
History of Changes
Purpose

Purpose

Open, prospective, multicenter French cohort study enrolling subjects aged of 15 years or more, during or immediately after HIV-1 primary infection. This cohort was organized from the outset to be highly multidisciplinary, bringing together immunologists, virologists, clinicians and epidemiologists.

Condition Intervention
HIV-1-infection

Biological : blood sampling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentric Cohort of HIV-1 (Human Immunodeficiency Virus 1) Primary Infection Cohort ANRS CO6 PRIMO

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures

  • Improve the physiological, pathological and virological knowledge of primary HIV infection [ Time Frame: up to 25 years ]
    Study of the immune mechanisms involved early after infection Kinetics of viral replication and establishment of cellular reservoirs at an early stage Relationships between virological markers and immune response kinetics Impact of resistance mutations, subtype and tropism on the disease progression and the response to treatment Study of sub-groups of specific patients followed since primary infection, spontaneous or post treatment controllers, subjects with specific HLA
Secondary Outcome Measures:
  • The impact of early, transient or prolonged treatment versus deferred treatment on the long-term prognosis of patients followed since primary infection, in terms of activation / inflammation [ Time Frame: up to 25 years ]
  • Contribute to knowledge in the epidemiology of HIV infection [ Time Frame: up to 25 years ]
    Modes of transmission Sexual behavior after HIV diagnosis Calendar trend of transmitted viral strains diversity (ARV resistance and subtypes) Calendar trend of marker levels measured at primary infection
  • Contribute to national recommendations for therapeutic care and evaluate their implementation [ Time Frame: up to 25 years ]

Biospecimen Retention: Samples With DNA
plasma, full blood, serum, lymphocytes and cells samples

Estimated Enrollment: 2550
Study Start Date: October 1996
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Follow-up Arm
Blood sampling only
Biological: blood sampling

Blood Sampling at J0, M1, M3, M6, M12, M18, M24 and every 6 months until the end of the study

Detailed Description:

Objectives: Follow up of patients infected by HIV-1 for less than three months.

  1. Improve the physiological and pathological knowledge of primary HIV infection
    • Study of the immune mechanisms involved early after infection
    • Kinetics of viral replication and establishment of cellular reservoirs at an early stage
    • Relationships between virological markers and immune response kinetics
    • Impact of resistance mutations, subtype and tropism on the disease progression and the response to treatment
    • Study of sub-groups of specific patients followed since primary infection, spontaneous or post treatment controllers, subjects with specific HLA
  2. Assessing the impact of early, transient or prolonged treatment versus deferred treatment on the long-term prognosis of patients followed since primary infection, in terms of activation / inflammation and decrease in viral reservoirs
  3. Contribute to knowledge in the epidemiology of HIV infection:
    • Modes of transmission
    • Sexual behavior after HIV diagnosis
    • Calendar trend of transmitted viral strains diversity (ARV resistance and subtypes)
    • Calendar trend of marker levels measured at primary infection
  4. Contribute to national recommendations for therapeutic care, evaluate their implementation
  5. Use observational data from the cohort for the development of therapeutic clinical
trials at primary infection

Eligibility

Eligibility

Ages Eligible for Study: 15 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

HIV-1 infected patients

Criteria

Inclusion Criteria:

  • symptomatic or asymptomatic HIV-1 primary infection.
  • Infection date based on one of the following criteria:
    1. Positive p24 antigenemia or detectable plasma HIV RNA with a negative ELISA within the previous six weeks.
    2. Positive p24 antigenemia or detectable plasma HIV RNA with a positive ELISA and negative Western Blot within the previous six weeks.
    3. Positive p24 antigenemia or detectable plasma HIV RNA or positive ELISA with incompleted Western Blot (no anti-p34 and/or anti-p68) within the previous six weeks.
    4. Positive ELISA with a negative ELISA within the last three months.
  • Age≥ 15 years old at the enrollment.
  • Naive of antiretroviral treatment except for transient treatment taken in the context of PMTCT, Pre-exposition prophylaxis or Post Exposition Prophylaxis.
  • Affiliate or beneficiary of a social security system (State Medical Assistance is not a social security scheme).


Exclusion Criteria:
  • Inability to give informed consent.
  • Predictable difficult follow-up.
  • Contraindication to repeated blood samples.
  • Under protection (saving) of justice
  • Life-threatening pathology (deferred inclusion is possible)

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03148964

Contacts

Contact:   Laurence Meyer, Professor +33145212334 laurence.meyer@inserm.fr
Contact:   Asma Essat, Doctor +33149591975 asma.essat@inserm.fr

Locations

France
Laurence Meyer Recruiting
Le Kremlin Bicêtre, France, 94276
Contact: Laurence Ms Meyer, Professor    0145212334 ext 33    laurence.meyer@inserm.fr
Principal Investigator: Cécile Ms Goujard, Professor

Sponsors and Collaborators

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Investigators

Principal Investigator: Laurence Meyer, Professor CESP-INSERM U1018
More Information

More Information


Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)  
ClinicalTrials.gov Identifier: NCT03148964   History of Changes  
Other Study ID Numbers: ANRS CO6 PRIMO  
Study First Received: April 12, 2017  
Last Updated: May 10, 2017  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Infection
Communicable Diseases

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.