Primary Infection Cohort

NCT03148964 | Unknown

• 1 other identifier: ANRS CO6 PRIMO
• Study Type: observational
• Target: 2,800
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

• Improve the physiological, pathological and virological 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

  up to 25 years

Secondary Outcomes (3)

• 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

  up to 25 years

• Contribute to knowledge in the epidemiology of HIV infection

  up to 25 years

• Contribute to national recommendations for therapeutic care and evaluate their implementation

  up to 25 years

Study Arms (1)

Follow-up Arm

Blood sampling only

Biological: blood sampling

Interventions

blood sampling BIOLOGICAL

Blood Sampling at J0, M1, M3, M6, M12, M24 and every 12 months until the end of the study

Follow-up Arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-1 infected patients

You may qualify if:

• symptomatic or asymptomatic HIV-1 primary infection.
• Infection date based on one of the following criteria:
• Positive p24 antigenemia or detectable plasma HIV RNA with a negative ELISA within the previous six weeks.
• Positive p24 antigenemia or detectable plasma HIV RNA with a positive ELISA and negative Western Blot within the previous six weeks.
• 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.
• 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).

You may not qualify if:

• Inability to give informed consent.
• Predictable difficult follow-up.
• Contraindication to repeated blood samples.
• Under protection (saving) of justice

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (1)

Laurence Meyer

Le Kremlin-Bicêtre, 94276, France

RECRUITING

Related Publications (1)

• Baltes V, de Boissieu P, Champenois K, Luan L, Seng R, Essat A, Novelli S, Spire B, Molina JM, Goujard C, Meyer L; ANRS PRIMO cohort study group. Sexual behaviour and STIs among MSM living with HIV in the PrEP era: the French ANRS PRIMO cohort study. J Int AIDS Soc. 2024 Mar;27(3):e26226. doi: 10.1002/jia2.26226.

  PMID: 38462760 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma, full blood, serum, lymphocytes and cells samples

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laurence Meyer, Professor

  CESP-INSERM U1018

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurence Meyer, Professor

CONTACT

+33145212334; laurence.meyer@inserm.fr

Asma Essat, Doctor

CONTACT

+33149591975; asma.essat@inserm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: May 11, 2017
• Study Start: October 1, 1996
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)