Primary Infection Cohort

HIV-1-infection Clinical Trial

— PRIMO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03148964
• Other study ID #: ANRS CO6 PRIMO
• Status: Recruiting
• Start date: October 1996
• Est. completion date: September 2025

Study information

• Verified date: October 2022
• Source: ANRS, Emerging Infectious Diseases
• Contact: Laurence Meyer, Professor
• Phone: +33145212334
• Email: laurence.meyer[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2800
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• HIV-1-infection
• Infections

Intervention

Biological:
• blood sampling
Blood Sampling at J0, M1, M3, M6, M12, M24 and every 12 months until the end of the study

Locations

Country	Name	City	State
France	Laurence Meyer	Le Kremlin Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Contribute to national recommendations for therapeutic care and evaluate their implementation		up to 25 years