Primary Infection Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2800 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-10-31

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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HIV-1-infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Follow-up Arm

Blood sampling only

blood sampling

Intervention Type BIOLOGICAL

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

Interventions

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blood sampling

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No