CABOTEGRAVIRNCT07402044
CABOTEGRAVIR/LENACAPAVIR DUAL LONG ACTING THERAPY (COHORT IMEA 074)
An observational study of CABOTEGRAVIR and LENACAPAVIR, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 13 sites in France.
Trial summary
The main objective of this national study is to evaluate the virological success of long-acting antiretroviral therapy combining cabotegravir and lenacapavir. The study involves patients who have been receiving this treatment for one year or those for whom the physician decides to initiate it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CABOTEGRAVIR, LENACAPAVIR
- How many people
- 50 participants
- Where
- 13 sitesFrance
- Study dates
- 15 Mar 2026to 15 Mar 2028
- How long will I take part?
- 48 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: people living with HIV (PLHIV) in France, receiving long-acting dual therapy with cabotegravir/lenacapavir for at least 48 weeks, comprising: (i) a retrospective component, including patients who started this treatment from July 2024 until the last available follow-up data collection; (ii) a prospective component, including patients for whom a medical decision to initiate this treatment is made during a 12-month recruitment period, with a planned follow-up of 48 weeks.
Who may be able to join
None listed.
Who cannot join
- Participants' objection to the use of follow-up data
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites
Victor Dupuy Hospital
Argenteuil
Fabienne CABY, 01 34 23 22 18 ext. 33, fabienne.caby@ch-argenteuil.fr
Pellegrin Hospital
Bordeaux
Didier NEAU, 05 57 82 27 97 ext. 33, didier.neau@chu-bordeaux.fr
Saint André Hospital
Bordeaux
Fabrice BONNET, 05 56 79 57 33, fabrice.bonnet@chu-bordeaux.fr
Raymond poincaré Hospital
Garches
Pierre de Truchis, 01 47 10 77 56, p.de-truchis@aphp.fr
Franco-British Hospital (Fbh)
Levallois-Perret
Gilles FORCE, 01 47 59 59 87 ext. 33, gilles.force@cognacq-jay.fr
Hotel Dieu Hospital
Nantes
Colin DESCHANVRES, 02 40 08 45 13, colin.deschanvres@chu-nantes.fr
Archet 1Hospital
Nice
David CHIRIO, 0492035461 ext. 33, chirio.d@chu-nice.fr
Bichat Claude Bernard Hospital
Paris
Roland LANDMAN, 01 40 25 48 27, roland.landman@aphp.fr
Hotel Dieu Hospital
Paris
Romain PALICH, 01 42 34 82 34 ext. 33, romain.palich@aphp.fr
Necker Hospital
Paris
Claudine DUVIVIER, 0142192717, claudine.duvivier@aphp.fr
Pitié Salpêtrière Hospital
Paris
Valérie POURCHER, 01 42 16 02 93 ext. 33, valerie.pourcher@aphp.fr
Saint Antoine Hospital
Paris
karine LACOMBE, 01 49 28 24 05 ext. 33, karine.lacombe2@aphp.fr
Tourcoing Hospital
Tourcoing
Nathalie VIGET, 03 20 69 46 17 ext. 33, nviget@ch-tourcoing.fr
About this study
Official title: CAbotégravir LENacapavir DUal Long Acting). Immuno-virological Monitoring and Safety Assessment of HIV-1 Infected Patients Receiving a Long-Acting Antiretroviral Combination of Cabotegravir and Lenacapavir
The main objective of this national study is to evaluate the virological success of long-acting antiretroviral therapy combining cabotegravir and lenacapavir. The study involves patients who have been receiving this treatment for one year or those for whom the physician decides to initiate it. It also aims to evaluate the tolerability of the treatment and changes in the participants' immunovirological profile during follow-up.
Read the detailed description
The CALENDULA cohort is a French multicenter study of people living with HIV (PLHIV) receiving long-acting dual therapy combining cabotegravir and lenacapavir (CAB/LEN) for at least 48 weeks.
The study has two parts:
Retrospective part: includes patients who started treatment between July 2024 and the date of the last available follow-up.
Prospective part: includes patients for whom the decision to initiate treatment is made during a 12-month recruitment period, with 48 weeks of follow-up.
No specific intervention is planned; data are simply collected from medical records.
Information will be collected at the following times after the start of treatment:
D0, W24, and W48.
The primary objective is to describe the virological response and tolerance of CAB/LEN dual therapy over 48 weeks.
Virological success is defined as maintaining a viral load (VL) < 50 copies/mL or suppression of VL at W48 without interruption of treatment.
The efficacy criterion is the virological failure rate at S48. The study aims to evaluate the feasibility and tolerability of this innovative therapeutic combination in order to prepare for a future larger-scale study on cabotegravir/lenacapavir.
- Conditions
- CABOTEGRAVIR, LENACAPAVIR
- Keywords
- Lenacapavir, Cabotegravir, HIV, Multicentre cohort
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with virological failure
Two consecutive viral load (VL) measurements ≥50 copies/mL after having achieved VL <50 copies/mL
Measured: Week 48
Percentage of participants with virological failure
ii. A single VL ≥50 copies/mL followed by permanent treatment discontinuation or loss to follow-up after previously achieving VL <50 copies/mL; or discontinuation with VL ≥50 copies/mL
Measured: Week 24
Percentage of participants with virological failure
A VL ≥50 copies/mL
Measured: Week48
Secondary outcomes (8)
1. Percentage of participants with therapeutic success using the FDA Snapshot approach (defined as absence of virological failure, permanent treatment discontinuation, or loss to follow-up).
Measured: Week48
2. Percentage of participants with viruses showing resistance-associated mutations.
Measured: Week 48
3. Percentage of participants experiencing at least one "blip"
Measured: from Week 24 to week 48
4. Plasma concentrations of antiretroviral drugs
Measured: from Week 24 to week 48
5. Changes in CD4 and CD8 T-cell counts and in the CD4/CD8 ratio
Measured: from enrollment to the end of treatment at 48 weeks
6. Incidence of adverse events and biological abnormalities
Measured: from enrollment to the end of the treatment at week 48
7. Changes in body weight and BMI
Measured: from the enrollment to the end the treatment at week 48
8. Changes in metabolic parameters
changes in Total cholesterol, HDL, LDL, Triglycerid, Glyceamia levels
Measured: From the enrollment to the end of treatment at week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABOTEGRAVIRStudies 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
- Other
- Enrolment
- 50 participants (estimated)
- Target duration
- 48 Weeks
Sponsor and investigators
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR S 1136, ANRS, Emerging Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- Roland LANDMAN, Principal investigator, Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402044
- Sponsor's protocol ID
- 2025-A02118-41
- Other IDs
- IDRCB
- Status last verified
- Mar 2026
- First submitted
- 18 Dec 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAbotégravir LENacapavir DUal Long Acting). Immuno-virological Monitoring and Safety Assessment of HIV-1 Infected Patients Receiving a Long-Acting Antiretroviral Combination of Cabotegravir and Lenacapavir
- ClinicalTrials.gov ID
- NCT07402044
- Acronym / sponsor ID
- 2025-A02118-41
- Conditions
- CABOTEGRAVIR, LENACAPAVIR
- Keywords
- Lenacapavir, Cabotegravir, HIV, Multicentre cohort
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'BaUniversity, hospital or other
- Collaborators
- INSERM UMR S 1136, ANRS, Emerging Infectious Diseases
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 11 Feb 2026 (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 main objective of this national study is to evaluate the virological success of long-acting antiretroviral therapy combining cabotegravir and lenacapavir. The study involves patients who have been receiving this treatment for one year or those for whom the physician decides to initiate it. It also aims to evaluate the tolerability of the treatment and changes in the participants' immunovirological profile during follow-up.
Detailed description
The CALENDULA cohort is a French multicenter study of people living with HIV (PLHIV) receiving long-acting dual therapy combining cabotegravir and lenacapavir (CAB/LEN) for at least 48 weeks.
The study has two parts:
Retrospective part: includes patients who started treatment between July 2024 and the date of the last available follow-up.
Prospective part: includes patients for whom the decision to initiate treatment is made during a 12-month recruitment period, with 48 weeks of follow-up.
No specific intervention is planned; data are simply collected from medical records.
Information will be collected at the following times after the start of treatment:
D0, W24, and W48.
The primary objective is to describe the virological response and tolerance of CAB/LEN dual therapy over 48 weeks.
Virological success is defined as maintaining a viral load (VL) < 50 copies/mL or suppression of VL at W48 without interruption of treatment.
The efficacy criterion is the virological failure rate at S48. The study aims to evaluate the feasibility and tolerability of this innovative therapeutic combination in order to prepare for a future larger-scale study on cabotegravir/lenacapavir.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 48 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people living with HIV (PLHIV) in France, receiving long-acting dual therapy with cabotegravir/lenacapavir for at least 48 weeks, comprising: (i) a retrospective component, including patients who started this treatment from July 2024 until the last available follow-up data collection; (ii) a prospective component, including patients for whom a medical decision to initiate this treatment is made during a 12-month recruitment period, with a planned follow-up of 48 weeks.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Participants' objection to the use of follow-up data
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
Percentage of participants with virological failure
Time frame: Week 48
Two consecutive viral load (VL) measurements ≥50 copies/mL after having achieved VL <50 copies/mL
Percentage of participants with virological failure
Time frame: Week 24
ii. A single VL ≥50 copies/mL followed by permanent treatment discontinuation or loss to follow-up after previously achieving VL <50 copies/mL; or discontinuation with VL ≥50 copies/mL
Percentage of participants with virological failure
Time frame: Week48
A VL ≥50 copies/mL
8 secondary outcomes
1. Percentage of participants with therapeutic success using the FDA Snapshot approach (defined as absence of virological failure, permanent treatment discontinuation, or loss to follow-up).
Time frame: Week48
2. Percentage of participants with viruses showing resistance-associated mutations.
Time frame: Week 48
3. Percentage of participants experiencing at least one "blip"
Time frame: from Week 24 to week 48
4. Plasma concentrations of antiretroviral drugs
Time frame: from Week 24 to week 48
5. Changes in CD4 and CD8 T-cell counts and in the CD4/CD8 ratio
Time frame: from enrollment to the end of treatment at 48 weeks
6. Incidence of adverse events and biological abnormalities
Time frame: from enrollment to the end of the treatment at week 48
7. Changes in body weight and BMI
Time frame: from the enrollment to the end the treatment at week 48
8. Changes in metabolic parameters
Time frame: From the enrollment to the end of treatment at week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes
Related trials for CABOTEGRAVIR
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
Active, not recruitingPhase 2
A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)
HIV Infections
Active, not recruitingPhase 1/2
Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age
HIV-1-infection
RecruitingPhase 1
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
HIV Infections
RecruitingPhase 4
Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
HIV -1 Infection
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.
Roland LANDMAN principal investigator
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CABOTEGRAVIR and LENACAPAVIR, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 13 sites 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 0 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roland LANDMAN (1 40 25 63 65 ext. 33, landman.roland@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with virological failure (time frame: Week 48). The study lists 3 primary outcomes in all. 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 27 Mar 2026.