Primary Infection Cohort

Recruiting

• Conditions: HIV-1-infection
• Interventions: Biological: blood sampling

• Registration Number: NCT03148964
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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.

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 Timeline

• Study Start: 1996-10
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-11
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-19
• Primary Completion: 2024-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Follow-up Arm	blood sampling	Blood sampling only

Primary Outcome Measures

Name	Time	Method
Improve the physiological, pathological and virological knowledge of primary HIV infection	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

Name	Time	Method
Contribute to knowledge in the epidemiology of HIV infection	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	up to 25 years
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

Trial Locations

Locations (1)

Laurence Meyer; 🇫🇷 Le Kremlin Bicêtre, France