Observational cohort for early HIV-1 infection
Multicentric Cohort of HIV-1 (Human Immunodeficiency Virus 1) Primary Infection Cohort ANRS CO6 PRIMO
This study is trying to learn more about early HIV-1 infection in people aged 15 and older to see how it affects their health and how different treatment timings might help them in the long run.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2800 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | ANRS, Emerging Infectious Diseases Government |
| Locations | 1 site (Le Kremlin Bicêtre) |
| Trial ID | NCT03148964 on ClinicalTrials.gov |
What this trial studies
This is an open, prospective, multicenter cohort study in France that enrolls individuals aged 15 and older who are experiencing primary HIV-1 infection. The study aims to enhance understanding of the physiological and pathological aspects of early HIV infection, including immune responses and viral replication dynamics. It also evaluates the effects of early versus deferred treatment on long-term health outcomes and gathers epidemiological data on HIV transmission and patient behavior. Blood samples will be collected for analysis throughout the study.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 15 years or older with symptomatic or asymptomatic primary HIV-1 infection.
Not a fit: Patients who are unable to provide informed consent or have previously received antiretroviral treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and better long-term outcomes for patients with HIV-1.
How similar studies have performed: Other studies have shown success in understanding early HIV infection dynamics, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Le Kremlin Bicêtre
- Laurence Meyer — Le Kremlin Bicêtre, France (Recruiting)
Study contacts
- Principal investigator: Laurence Meyer, Professor — Cesp-Inserm U1018
- Study coordinator: Laurence Meyer, Professor
- Email: laurence.meyer@inserm.fr
- Phone: +33145212334
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.