NCT07402044

Brief 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. It also aims to evaluate the tolerability of the treatment and changes in the participants' immunovirological profile during follow-up.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started Mar 2026

Geographic Reach
1 country

13 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

December 18, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2028

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

December 18, 2025

Last Update Submit

March 23, 2026

Conditions

CABOTEGRAVIRLENACAPAVIR

Keywords

LenacapavirCabotegravirHIVMulticentre cohort

Outcome Measures

Primary Outcomes (3)

  • Percentage of participants with virological failure

    Two consecutive viral load (VL) measurements ≥50 copies/mL after having achieved VL \<50 copies/mL

    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

    Week 24

  • Percentage of participants with virological failure

    A VL ≥50 copies/mL

    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).

    Week48

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

    Week 48

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

    from Week 24 to week 48

  • 4. Plasma concentrations of antiretroviral drugs

    from Week 24 to week 48

  • 5. Changes in CD4 and CD8 T-cell counts and in the CD4/CD8 ratio

    from enrollment to the end of treatment at 48 weeks

  • +3 more secondary outcomes

Other Outcomes (2)

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

    Week 24

  • Percentage of participants experiencing at least one "blip

    Week 48

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Victor Dupuy Hospital

Argenteuil, France

Location

Pellegrin Hospital

Bordeaux, France

Location

Saint André Hospital

Bordeaux, France

Location

Raymond poincaré Hospital

Garches, France

Location

Franco-British Hospital (Fbh)

Levallois-Perret, France

Location

Hotel Dieu Hospital

Nantes, France

Location

Archet 1Hospital

Nice, France

Location

Bichat Claude Bernard Hospital

Paris, France

Location

Hotel Dieu Hospital

Paris, France

Location

Necker Hospital

Paris, France

Location

Pitié Salpêtrière Hospital

Paris, France

Location

Saint Antoine Hospital

Paris, France

Location

Tourcoing Hospital

Tourcoing, France

Location

Study Officials

  • Roland LANDMAN

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland LANDMAN

CONTACT

1 40 25 63 65landman.roland@gmail.com

Aïda BENALYCHERIF

CONTACT

1 40 25 63 65aida.benalycherif@fondation-imea.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
48 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2025

First Posted

February 11, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

March 15, 2028

Study Completion (Estimated)

March 15, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF

Locations

FR(13)