HIV-1-infectionLONGADAPTNCT05433987
Immune Activation Markers in HIV-infected Patients Switching to Long Acting Dual Therapy
An observational study of HIV-1-infection, run by Centre Hospitalier de Cannes Simone Veil at 1 site in France.
Trial summary
The purpose of the study is to measure the impact on immune activation and inflammatory markers of switching from a triple combination antiretroviral therapy (cART) to a long acting dual therapy in HIV-infected patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2022to 17 Nov 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient HIV-1, regularly followed in Cannes and Nice Hospital and for which the doctor has decided to modify the treatment
Who may be able to join
- Patients agreeing to participate to the study and to collect their data
- HIV-1 infected subjects
- Patients switching from a stable (at least 6 months) and successful triple cART to a long acting dual cART
- Patients older than 18 yrs and regularly followed in Cannes and Nice hospitals
- Patients with a healthcare card
Who cannot join
- HIV-2 infected subjects
- Patients not being on successful and stable cART
- Patients having being treated during acute HIV-infection
- Patients modifying cART for virological failure
- Subjects modifying their treatment for another combination than from a triple cART to a dual cART
- Patients modifying cART during the 6 months of follow-up
Show all 9Show fewer
- Patients refusing to participate to the study
- Patients included in an interventional study during the 6 months of follwo-up
- Patient under juridical procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Aiming to Measure the Impact on Immune Activation and Inflammatory Markers of Switching From a Triple Combination Antiretroviral Therapy (cART) to a Long Acting Dual Therapy in HIV-infected Patients
The purpose of the study is to measure the impact on immune activation and inflammatory markers of switching from a triple combination antiretroviral therapy (cART) to a long acting dual therapy in HIV-infected patients
Read the detailed description
Patients meeting the inclusion criteria will be offered to participate to the study.
In case of acceptance by given their writting consent, 6 ml of blood will be collected for measuring immune activation and inflammatory markers, during the blood test scheduled for the routine follow-up.
Six months after cART change, an equal volume of blood will be collected for measuring the same immune activation and inflammatory markers
- Conditions
- HIV-1-infection
- Keywords
- inflammatory markers, dual therapy, treatment simplification
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution the trajectory of immune activation and inflammatory markers
Assess the trajectory of immune activation and inflammatory markers change at 6 month after modifying cART
Measured: Baseline and 6 months after modiyfying cART
Secondary outcomes (1)
Prevalence of patients with successful cART
To evaluate prevalence of patients with successful cART (i.e. viral load below 50 copies/ml) 1 month after the switch
Measured: 1 month, 3 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start28 Jul 2022
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cannes Simone Veil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matteo Vassallo, MD, Principal investigator, Centre Hospitalier de Cannes Simone Veil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433987
- Sponsor's protocol ID
- CHC-PI-2022-01
- Acronym
- LONGADAPT
- Status last verified
- Aug 2024
- First submitted
- 21 Jun 2022
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Aiming to Measure the Impact on Immune Activation and Inflammatory Markers of Switching From a Triple Combination Antiretroviral Therapy (cART) to a Long Acting Dual Therapy in HIV-infected Patients
- ClinicalTrials.gov ID
- NCT05433987
- Acronym / sponsor ID
- LONGADAPT / CHC-PI-2022-01
- Conditions
- HIV-1-infection
- Keywords
- inflammatory markers, dual therapy, treatment simplification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier de Cannes Simone VeilUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 27 Jun 2022 (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.
The purpose of the study is to measure the impact on immune activation and inflammatory markers of switching from a triple combination antiretroviral therapy (cART) to a long acting dual therapy in HIV-infected patients
Detailed description
Patients meeting the inclusion criteria will be offered to participate to the study.
In case of acceptance by given their writting consent, 6 ml of blood will be collected for measuring immune activation and inflammatory markers, during the blood test scheduled for the routine follow-up.
Six months after cART change, an equal volume of blood will be collected for measuring the same immune activation and inflammatory markers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient HIV-1, regularly followed in Cannes and Nice Hospital and for which the doctor has decided to modify the treatment
Key inclusion criteria (5 listed)
- Patients agreeing to participate to the study and to collect their data
- HIV-1 infected subjects
- Patients switching from a stable (at least 6 months) and successful triple cART to a long acting dual cART
- Patients older than 18 yrs and regularly followed in Cannes and Nice hospitals
- Patients with a healthcare card
Key exclusion criteria (9 listed)
- HIV-2 infected subjects
- Patients not being on successful and stable cART
- Patients having being treated during acute HIV-infection
- Patients modifying cART for virological failure
- Subjects modifying their treatment for another combination than from a triple cART to a dual cART
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evolution the trajectory of immune activation and inflammatory markers
Time frame: Baseline and 6 months after modiyfying cART
Assess the trajectory of immune activation and inflammatory markers change at 6 month after modifying cART
1 secondary outcome
Prevalence of patients with successful cART
Time frame: 1 month, 3 month, 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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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.
Matteo Vassallo, MD principal investigator
Centre Hospitalier de Cannes Simone Veil
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 Centre Hospitalier de Cannes Simone Veil 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 28 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution the trajectory of immune activation and inflammatory markers (time frame: Baseline and 6 months after modiyfying cART). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2024.