Primary Infection Cohort (PRIMO)

Multicentric Cohort of HIV-1 (Human Immunodeficiency Virus 1) Primary Infection Cohort ANRS CO6 PRIMO

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.

Study Overview

• Status: Recruiting
• Conditions: HIV-1-infection
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Anticipated): 2800

Contacts and Locations

• Study Contact: Name: Laurence Meyer, Professor; Phone Number: +33145212334; Email: laurence.meyer@inserm.fr
• Study Contact Backup: Name: Asma Essat, Doctor; Phone Number: +33149591975; Email: asma.essat@inserm.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-1 infected patients

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Follow-up Arm; Blood sampling only	Biological: blood sampling; Blood Sampling at J0, M1, M3, M6, M12, M24 and every 12 months until the end of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	up to 25 years
Contribute to national recommendations for therapeutic care and evaluate their implementation		up to 25 years

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Investigators: Principal Investigator: Laurence Meyer, Professor, CESP-INSERM U1018

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 1996
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: ANRS CO6 PRIMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No