HIV1 InfectionPhase 2CALENDULANCT06657885
CAbotégravir LENacapavir DUal Long Acting
A Phase 2 study testing 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 in people with HIV1 Infection and Multi-treated Patients Who Have Received Multiple Lines of Antiretroviral Treatment, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- HIV1 Infection, Multi-treated Patients Who Have Received Multiple Lines of Antiretroviral Treatment, CABOTEGRAVIR
- What is being tested?
- 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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 12 sitesFrance
- Study dates
- 15 Jan 2025to 15 Sep 2026
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Age ≥ 18 years
- HIV-1 infection
- Stable oral antiretroviral treatment for at least 6 months
- Multi-treated patients who have received multiple lines of antiretroviral treatment
- Undetectable patients with CV < 50 copies/mL in the last 6 months (a single blip between 50 and 200 copies/mL in the last 6 months is allowed) and eligible to switch to the lenacapavir/cabotegravir strategy on the basis of 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
- 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).
Non-inclusion criteria
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Hopital Saint André
Bordeaux
Hopiytal Pellegrin
Bordeaux
Centre hospitalier François Mitterrand
Dijon
Hopital raymond Poincaré
Garches
Hôpital Franco-Britannique
Levallois-Perret
CHU de nantes- Hotel Dieu
Nantes
Chu- Nice Archet
Nice
Hopital Saint Antoine
Paris, 75012
Hopital Pitié Salpêtrière
Paris, 75013
Hopital Necker
Paris, 75015
Hopital Bichat Claude Bernard
Paris, 75018
Centre hospitalier de Tourcoing
Tourcoing
About this study
Official title: Phase II, Pilot Study, Open Label, Multicenter, Evaluating Dual Antiretroviral Therapy With Long-acting Cabotegravir/Lenacapavir
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).
Read more
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
- Being tested
- 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
- Keywords
- CAbotégravir LENacapavir DUal Long Acting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 lenacapaviDrug
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
| Study group | Role | What they receive |
|---|---|---|
| single-arm | Experimental | Not described Receives: Drug: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with virological failure
Measured: week 48
Percentage of participants with virological failure
Measured: Week 24
Secondary outcomes (16)
Percentage of participants with virological failure
Measured: Week 24, week48
Percentage of participants achieving therapeutic success at W48 (absence of virological failure and definitive discontinuation of assigned treatment or study continuation due to intolerance). Change of residence, change of treatment due to pregnancy, for
Measured: week 48
Percentage of participants with viruses harbouring resistance mutations to the current treatment at the time of virological failure (by Sanger) and description of the resistance mutations selected at the time of virological failure.
Measured: at the time of virologic failure
Proportion of minority resistance variants archived in DNA at D0 and their impact on the risk of virological failure and on the selection of resistance mutations.
Measured: D0
Describe the evolution of the proportion of intact and defective proviruses in PBMC at D0 and W48.
Measured: day 0 and week 48
Percentage of participants with at least one "blip" (viral load greater than 50 copies/mL with a control less than or equal to 50 copies/mL) between D0 and W48.
Measured: Between day 0 and week 48
Change in CD4 and CD8 T lymphocytes and CD4/CD8 ratio between W-2 and W48
Measured: Week -2 and week 48
Description of plasma concentrations of antiretroviral treatments between D0 and W48
Measured: between day0 and week 48
Incidence of clinical and laboratory grade 3 or higher adverse events
Measured: betwwen Day 0 and week 48
Incidence of adverse events and discontinuation from study to W48
Measured: Between day 0 and week 48
Changes in weight and BMI from D0 to W48
Measured: Between day 0 and week 48
Metabolic parameters (total cholesterol, LDL-c, HDL-c, triglycerides and fasting plasma glucose) from D0 to W48
Measured: Between day 0 and week 48
Change in participants' symptoms as assessed by self-report questionnaire from D0 to W48
Measured: Between day 0 and week 48
Assessment of participant satisfaction by questionnaire between D0 and W48
Measured: Between day 0 and week 48
Percentage of participants with virological failure
Measured: week24 and week 48
Percentage of participants with virological failure
Measured: week24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start15 Jan 2025 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Why it stopped: No response regarding coverage of treatments by social security and the DGOS
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV1 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- Sponsor type
- University, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- Roland LANDMAN, Principal investigator, IMEA and Bichat hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657885
- Sponsor's protocol ID
- IMEA 069
- Other IDs
- 2024-516028-33-01
- Acronym
- CALENDULA
- Status last verified
- Sep 2024
- First submitted
- 22 Jun 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Pilot Study, Open Label, Multicenter, Evaluating Dual Antiretroviral Therapy With Long-acting Cabotegravir/Lenacapavir
- ClinicalTrials.gov ID
- NCT06657885
- Acronym / sponsor ID
- CALENDULA / IMEA 069
- 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
- Keywords
- CAbotégravir LENacapavir DUal Long Acting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No response regarding coverage of treatments by social security and the DGOS
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'BaUniversity, hospital or other
- Collaborators
- ANRS, Emerging Infectious Diseases
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 26 Oct 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm | Experimental | Drug: 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 lenacapavicabotegravir 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 | Drug | single-arm |
Primary outcome
Percentage of participants with virological failure
Time frame: week 48
Percentage of participants with virological failure
Time frame: Week 24
16 secondary outcomes
Percentage of participants with virological failure
Time frame: Week 24, week48
Percentage of participants achieving therapeutic success at W48 (absence of virological failure and definitive discontinuation of assigned treatment or study continuation due to intolerance). Change of residence, change of treatment due to pregnancy, for
Time frame: week 48
Percentage of participants with viruses harbouring resistance mutations to the current treatment at the time of virological failure (by Sanger) and description of the resistance mutations selected at the time of virological failure.
Time frame: at the time of virologic failure
Proportion of minority resistance variants archived in DNA at D0 and their impact on the risk of virological failure and on the selection of resistance mutations.
Time frame: D0
Describe the evolution of the proportion of intact and defective proviruses in PBMC at D0 and W48.
Time frame: day 0 and week 48
Percentage of participants with at least one "blip" (viral load greater than 50 copies/mL with a control less than or equal to 50 copies/mL) between D0 and W48.
Time frame: Between day 0 and week 48
Change in CD4 and CD8 T lymphocytes and CD4/CD8 ratio between W-2 and W48
Time frame: Week -2 and week 48
Description of plasma concentrations of antiretroviral treatments between D0 and W48
Time frame: between day0 and week 48
Incidence of clinical and laboratory grade 3 or higher adverse events
Time frame: betwwen Day 0 and week 48
Incidence of adverse events and discontinuation from study to W48
Time frame: Between day 0 and week 48
Changes in weight and BMI from D0 to W48
Time frame: Between day 0 and week 48
Metabolic parameters (total cholesterol, LDL-c, HDL-c, triglycerides and fasting plasma glucose) from D0 to W48
Time frame: Between day 0 and week 48
Change in participants' symptoms as assessed by self-report questionnaire from D0 to W48
Time frame: Between day 0 and week 48
Assessment of participant satisfaction by questionnaire between D0 and W48
Time frame: Between day 0 and week 48
Percentage of participants with virological failure
Time frame: week24 and week 48
Percentage of participants with virological failure
Time frame: week24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Roland LANDMAN principal investigator
IMEA and Bichat hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 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 in people with HIV1 Infection and Multi-treated Patients Who Have Received Multiple Lines of Antiretroviral Treatment, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 12 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?
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: withdrawn, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percentage of participants with virological failure (time frame: week 48). The study lists 2 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 14 Jan 2026.