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Primary Infection Cohort (PRIMO)

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ClinicalTrials.gov Identifier: NCT03148964
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : May 11, 2017
Sponsor:
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)

Brief Summary:
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 or disease Intervention/treatment
HIV-1-infection Biological: blood sampling

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

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Study Type : Observational
Estimated Enrollment : 2550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentric Cohort of HIV-1 (Human Immunodeficiency Virus 1) Primary Infection Cohort ANRS CO6 PRIMO
Actual Study Start Date : October 1996
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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

  3. 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


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148964


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

Locations
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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
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Principal Investigator: Laurence Meyer, Professor CESP-INSERM U1018

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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
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Infection
Communicable Diseases