CAbotégravir LENacapavir DUal Long Acting

NCT ID: NCT06657885

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2026-09-15

Brief Summary

This study is a Phase II, prospective, single-arm, multicenter, non-randomized pilot study designed to evaluate the antiretroviral efficacy of lenacapavir in combination with cabotegravir injection over 48 weeks of follow-up in participants who meet the study inclusion criteria. Efficacy is defined as the absence of virologic failure at S48. Virologic success is defined as maintaining or achieving CV < 50 copies/mL without interruption of long-acting dual therapy with cabotegravir/lenacapavir at the end of 48 weeks. The study will be conducted at several sites in France in adults 18 years of age and older. Minors and persons under legal guardianship will not be included in the study.

Long-acting treatments are evolving thanks to new "long-acting" molecules. These molecules ensure prolonged efficacy without the need for daily dosing thanks to their long half-life by oral / IM or SC injection (cabotegravir, islatravir, lenacapavir, rilpivirine and bNAbs).

Currently, the only available combination is dual therapy with cabotegravir/rilpivirine administered intramuscularly every two months. However, this injectable combination therapy has its limitations, namely previous resistance to rilpivirine, a number of failures due to certain virological subtypes or poor use of the injectable by certain patients (obesity, injection errors, etc.). For many referral centers caring for patients with HIV, it has become necessary to have a long-acting therapeutic alternative for certain patients. A strategy based on lenacapavir combined with cabotegravir could be a validated alternative for undetectable or detectable patients who have received intensive multidrug regimens, for patients with multidrug resistance, or for patients who are unable to take their oral antiretroviral regimens due to intolerance, drug-drug interactions, or non-adherence.

Recently in the US, the case series presented by Dr. Monica Gandhi (Case series examining the Long-Acting combination of Lenacapavir and Cabotegravir: call for a trial-abstract 629 CROI 2024) demonstrated the high virologic efficacy (94%) of this combination in participants who were unobserved, intolerant or had underlying resistance to antiretroviral therapy (NNRTIs).

The experimental drugs used in this study are cabotegravir, marketed as Vocabria®, and lenacapavir, marketed as Sunlenca®. Both are approved in France for the treatment of HIV-1 infection.

Conditions

HIV1 Infection; Multi-treated Patients Who Have Received Multiple Lines of Antiretroviral Treatment; CABOTEGRAVIR; LENACAPAVIR; Stable Oral Antiretroviral Treatment for at Least 6 Months

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single-arm

Group Type: EXPERIMENTAL

his is a prospective, single-arm, multicentre, non-randomised phase II, pilot study designed to achieve or maintain virological success in participants who meet the prescribing criteria for lenacapavi

Intervention Type: DRUG

cabotegravir initiation: daily oral route of 1 tablet 30 mg at Day 0 to week 4 Cabotegravir maintennace: Every 8 weeks (+/- 1 week) intramuscular injection from week 8 at week 48.

Lenacapavir initiation: Subcutaneous injection (927mg/3ml),ie 2 injections of 463,5mg/1,5mL in 2 distinct abdominal sites + orale route of 2 tablets of 300mg (ie 600 mg) at Day 0 and at day 1: orale route of 2 tablets of 300mg (ie 600 mg) Lenacapavir maintenance: Subcutaneous injection (927mg/3ml),ie 2 injections of 463,5mg/1,5mL in 2 distinct abdominal sites every 24 weeks (+/-1 week) from Day 0 to Week 48

Interventions

his is a prospective, single-arm, multicentre, non-randomised phase II, pilot study designed to achieve or maintain virological success in participants who meet the prescribing criteria for lenacapavi

cabotegravir initiation: daily oral route of 1 tablet 30 mg at Day 0 to week 4 Cabotegravir maintennace: Every 8 weeks (+/- 1 week) intramuscular injection from week 8 at week 48.

Lenacapavir initiation: Subcutaneous injection (927mg/3ml),ie 2 injections of 463,5mg/1,5mL in 2 distinct abdominal sites + orale route of 2 tablets of 300mg (ie 600 mg) at Day 0 and at day 1: orale route of 2 tablets of 300mg (ie 600 mg) Lenacapavir maintenance: Subcutaneous injection (927mg/3ml),ie 2 injections of 463,5mg/1,5mL in 2 distinct abdominal sites every 24 weeks (+/-1 week) from Day 0 to Week 48

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• the presence of resistance mutations, including to NNRTIs
• or oral drug intolerance
• or drug-drug interactions
• Detectable, virologically uncontrolled HIV viral load ≥ 200 c/mL in the last 12 months who is eligible to switch to the lenacapavir/cabotegravir strategy based on a collegial decision by clinicians, virologists and pharmacologists following a multidisciplinary meeting due to
• the presence of resistance mutations, including to NNRTIs
• or oral drug intolerance
• or drug-drug interactions
• ASAT and ALAT < 3N
• Creatinine GFR > 60 mL/min (CKD-EPI)
• Haemoglobin > 10 g/dL
• Platelets > 100 000/mm3
• Commitment to use preventive and protective means of sexual intercourse for the duration of the trial.
• For women at risk of pregnancy, commitment to use an effective method of contraception for the duration of the study.
• Affiliated or beneficiary of a social security scheme (article L1121-11 of the French Public Health Code),
• Free, informed, written consent, signed by the person and the investigator no later than the day of inclusion and before any examination carried out as part of the study (article L1122-1-1 of the French Public Health Code).

• HIV-2 infection or HIV-1/HIV2 co-infection
• HIV-1 subtype A6/A1
• BMI ≥ 30kg/m².
• Chronic active viral hepatitis B with positive Hbs antigen
• Active chronic viral hepatitis C requiring specific treatment over the next 48 weeks.
• Treatment with interferon, interleukin or any other immunotherapy or chemotherapy in progress.
• Active opportunistic infection, or acute treatment for opportunistic infection
• Any condition (alcohol, drugs, neurological or neuropsychiatric disorders, etc.) likely to compromise tolerance of treatment and/or patient compliance with treatment and adherence to the protocol, as judged by the investigator.
• Women who are breastfeeding, pregnant or refusing contraception
• Taking medication contraindicated with the trial treatment
• Major incapacity, legal protection, guardianship or curatorship
• Planning to move house within the next 18 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland LANDMAN

Role: PRINCIPAL_INVESTIGATOR

IMEA and Bichat hospital

Locations

Hopital Saint André

Bordeaux, , France

Hopiytal Pellegrin

Bordeaux, , France

Centre hospitalier François Mitterrand

Dijon, , France

Hopital raymond Poincaré

Garches, , France

Hôpital Franco-Britannique

Levallois-Perret, , France

CHU de nantes- Hotel Dieu

Nantes, , France

Chu- Nice Archet

Nice, , France

Hopital Saint Antoine

Paris, , France

Hopital Pitié Salpêtrière

Paris, , France

Hopital Necker

Paris, , France

Hopital Bichat Claude Bernard

Paris, , France

Centre hospitalier de Tourcoing

Tourcoing, , France

Countries

France

Other Identifiers

2024-516028-33-01

Identifier Type: CTIS

Identifier Source: secondary_id

IMEA 069

Identifier Type: -

Identifier Source: org_study_id