HIV-1-infectionPRIMONCT03148964
Primary Infection Cohort
An observational study of HIV-1-infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- blood sampling
- How many people
- 2,800 participants
- Where
- 1 siteFrance
- Study dates
- Oct 1996to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV-1 infected patients
Who may be able to join
- symptomatic or asymptomatic HIV-1 primary infection.
- Infection date based on one of the following criteria:
- Positive p24 antigenemia or detectable plasma HIV RNA with a negative ELISA within the previous six weeks.
- Positive p24 antigenemia or detectable plasma HIV RNA with a positive ELISA and negative Western Blot within the previous six weeks.
- 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.
- Positive ELISA with a negative ELISA within the last three months.
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- 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).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Laurence Meyer
Le Kremlin-Bicêtre, 94276
Laurence Ms Meyer, Professor, 0145212334 ext. 33, laurence.meyer@inserm.fr
Cécile Ms Goujard, Professor
About this study
Official title: 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.
Read the detailed description
Objectives: Follow up of patients infected by HIV-1 for less than three months.
- 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
- 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
- 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
- Contribute to national recommendations for therapeutic care, evaluate their implementation
- Use observational data from the cohort for the development of therapeutic clinical trials at primary infection
- Conditions
- HIV-1-infection
- Being tested
- blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
Blood Sampling at J0, M1, M3, M6, M12, M24 and every 12 months until the end of the study
| Study group | Role | What they receive |
|---|---|---|
| Follow-up Arm | Blood sampling only Receives: Biological: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 25 years
Secondary outcomes (3)
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
Measured: 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
Measured: up to 25 years
Contribute to national recommendations for therapeutic care and evaluate their implementation
Measured: up to 25 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study startOct 1996
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Laurence Meyer, Professor, Principal investigator, CESP-INSERM U1018
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148964
- Sponsor's protocol ID
- ANRS CO6 PRIMO
- Acronym
- PRIMO
- Status last verified
- Oct 2022
- First submitted
- 12 Apr 2017
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baltes V, de Boissieu P, Champenois K, Luan L, Seng R, Essat A, Novelli S, Spire B, Molina JM, Goujard C, Meyer L; ANRS PRIMO cohort study group. Sexual behaviour and STIs among MSM living with HIV in the PrEP era: the French ANRS PRIMO cohort study. J Int AIDS Soc. 2024 Mar;27(3):e26226. doi: 10.1002/jia2.26226.
PubMed 38462760
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Cohort of HIV-1 (Human Immunodeficiency Virus 1) Primary Infection Cohort ANRS CO6 PRIMO
- ClinicalTrials.gov ID
- NCT03148964
- Acronym / sponsor ID
- PRIMO / ANRS CO6 PRIMO
- Conditions
- HIV-1-infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Oct 1996 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- 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
- 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
- Contribute to national recommendations for therapeutic care, evaluate their implementation
- Use observational data from the cohort for the development of therapeutic clinical trials at primary infection
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow-up Arm | – | Biological: blood samplingBlood sampling only |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV-1 infected patients
Key inclusion criteria (9 listed)
- symptomatic or asymptomatic HIV-1 primary infection.
- Infection date based on one of the following criteria:
- 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).
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingBlood Sampling at J0, M1, M3, M6, M12, M24 and every 12 months until the end of the study | Biological | Follow-up Arm |
Primary outcome
Improve the physiological, pathological and virological knowledge of primary HIV infection
Time frame: 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
3 secondary outcomes
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
Time frame: up to 25 years
Contribute to knowledge in the epidemiology of HIV infection
Time frame: up to 25 years
Contribute to national recommendations for therapeutic care and evaluate their implementation
Time frame: up to 25 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Derived from this study: PubMed 38462760Baltes V, de Boissieu P, Champenois K, Luan L, Seng R, Essat A, Novelli S, Spire B, Molina JM, Goujard C, Meyer L; ANRS PRIMO cohort study group. Sexual behaviour and STIs among MSM living with HIV in the PrEP era: the French ANRS PRIMO cohort study. J Int AIDS Soc. 2024 Mar;27(3):e26226. doi: 10.1002/jia2.26226.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Meyer, Professor principal investigator
CESP-INSERM U1018
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurence Meyer, Professor (+33145212334, laurence.meyer@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve the physiological, pathological and virological knowledge of primary HIV infection (time frame: up to 25 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03148964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.