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NCT Number: NCT07402044

CABOTEGRAVIR/LENACAPAVIR DUAL LONG ACTING THERAPY (COHORT IMEA 074)

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.

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Key information

Conditions

Cabotegravir Lenacapavir

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Victor Dupuy Hospital, Argenteuil, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Age ≥18 years
  • HIV-1 infection
  • Patients who started taking cabotegravir combined with lenacapavir between July 2024 and the one-year follow-up, or who are due to start taking the CAB/LEN combination.
  • Patients who are due to start the CAB/LEN combination following a medical decision.

Exclusion criteria

  • Participants' objection to the use of follow-up data

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. Percentage of participants with virological failure

    Time frame: Week48

    A VL ≥50 copies/mL

Secondary outcomes

  1. 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. 2. Percentage of participants with viruses showing resistance-associated mutations.

    Time frame: Week 48

  3. 3. Percentage of participants experiencing at least one "blip"

    Time frame: from Week 24 to week 48

  4. 4. Plasma concentrations of antiretroviral drugs

    Time frame: from Week 24 to week 48

  5. 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. 6. Incidence of adverse events and biological abnormalities

    Time frame: from enrollment to the end of the treatment at week 48

  7. 7. Changes in body weight and BMI

    Time frame: from the enrollment to the end the treatment at week 48

  8. 8. Changes in metabolic parameters

    Time frame: From the enrollment to the end of treatment at week 48

    changes in Total cholesterol, HDL, LDL, Triglycerid, Glyceamia levels

Other outcomes

  1. 3. Percentage of participants experiencing at least one "blip

    Time frame: Week 24

  2. Percentage of participants experiencing at least one "blip

    Time frame: Week 48

Study contacts

Contact information is provided by the study sponsor or research team.

Aïda BENALYCHERIF

CONTACT

[email protected]

1 40 25 63 65 ext. +33

Roland LANDMAN

CONTACT

[email protected]

1 40 25 63 65 ext. 33

Sponsors and collaborators

Lead sponsor

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Other

Collaborators

  • ANRS, Emerging Infectious Diseases
  • INSERM UMR S 1136

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 11, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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