AzTrials
AzTrials

PreventionPhase 3CABOPrEPNCT06273943

Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France.

A Phase 3 study testing Cabotegravir Tablets, for oral use., Cabotegravir Extended-Release Injectable Suspension, for intramuscular use. and Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use in people with Prevention, run by ANRS, Emerging Infectious Diseases at 8 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate if offering long-acting injectable cabotegravir (CAB-LA) as an additional HIV prevention choice among oral PrEP-experienced men who have sex with men (MSM) in France can significantly increase the sustained PrEP use over time and the PrEP coverage of at-risk sexual risk… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prevention
What is being tested?
Cabotegravir Tablets, for oral use., Cabotegravir Extended-Release Injectable Suspension, for intramuscular use. and Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use
Could I receive a placebo?
No, everyone receives an active treatment
How many people
322 participants
Where
8 sitesFrance
Study dates
1 Apr 2024to 30 Oct 2026
Phase
Phase 3
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years.
  • Cisgender men who have sex with men.
  • Have taken oral TDF/FTC based PrEP during the past 6 months, either daily or on-demand, with a documented PrEP prescription.
  • Agreeing to be contacted personally by telephone (call, SMS) or e-mail.
  • Person affiliated with or a beneficiary of a social security scheme (article L1121-11 of the Public Health Code).
  • Informed and written consent, signed by the person and the investigator on the day of inclusion, at the latest, and before any examination carried out within the setting of the study (article L1122-1-1 of the Public Health Code).
Show all 28Show fewer
  • Non-inclusion criteria
  • Positive HIV test result at screening or enrollment visit, even if HIV infection is not confirmed.
  • Symptoms and/or clinical signs consistent with an acute HIV infection.
  • History of seizure disorder.
  • Ongoing Post-Exposure Prophylaxis (PEP) for HIV.
  • Last titer of hepatitis B surface antibody (anti-HBs) < 10 mIU/mL.
  • Concomitant use of antimycobacterial (rifampin, rifapentine) or enzyme-inducing anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin, etc.).
  • Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
  • Participants having a non-treated chronic HCV infection.
  • Current or chronic history of liver disease or known hepatic or biliary abnormalities.
  • Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 5-fold the upper normal limit (UNL).
  • Creatinine clearance lower than 50mL/min.
  • History of chronic renal disease, osteoporosis or osteopenia.
  • Inflammatory skin conditions which compromise the safety of intramuscular (IM) injections.
  • Known thrombocytopenia or any other known bleeding disorder, which would contraindicate IM injection.
  • Treatment with oral anticoagulant (antiplatelet agents are allowed).
  • Known or suspected allergy to study product components.
  • Surgically placed buttock implants.
  • Planned trip abroad of more than 2 consecutive months or planned move outside the Ile de France region.
  • Individuals who, upon the investigator's judgement, will not be likely to comply the clinical trial procedures, or with any condition incompatible with study participation.
  • Person participating in another research study with an exclusion period still in progress at inclusion. Participants in the ANRS PREVENIR study are authorized to participate in the ANRS CABOPrEP trial.
  • Person under guardianship or curatorship or deprived of liberty by judicial or administrative decision.

Who cannot join

None listed.

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Geoffroy LIEGEON, Dr contact

312-483-6988 ext. +1

geoffroy.liegeon@aphp.fr

8 sites in 1 country

France8 sites

  • Hôpital Hôtel Dieu

    Paris, Île-de-France Region, 75004

  • Hôpital Lariboisière

    Paris, Île-de-France Region, 75010

  • Hôpital Saint Louis

    Paris, Île-de-France Region, 75010

  • Hôpital Saint Antoine

    Paris, Île-de-France Region, 75012

  • Hôpital La Pitié Salpêtrière

    Paris, Île-de-France Region, 75013

  • Hôpital Necker

    Paris, Île-de-France Region, 75015

  • Hôpital Bichat

    Paris, Île-de-France Region, 75018

  • Hôpital Tenon

    Paris, Île-de-France Region, 75020

Other trials in France

About this study

Official title: Impact of Long-acting Injectable Cabotegravir for HIV Pre-exposure Prophylaxis Persistence and Coverage in Men Who Have Sex With Men in France: a Randomized Controlled Clinical Trial.

The purpose of this study is to evaluate if offering long-acting injectable cabotegravir (CAB-LA) as an additional HIV prevention choice among oral PrEP-experienced men who have sex with men (MSM) in France can significantly increase the sustained PrEP use over time and the PrEP coverage of at-risk sexual risk behaviors.

Read the detailed description

Long-acting injectable cabotegravir (CAB-LA) is a promising agent to address the issue of uptake, adherence, and persistence among oral PrEP users who faced adherence challenges. However, the potential benefits of offering CAB-LA as an additional prevention option for MSM adherent to oral PrEP has yet to be demonstrated. We hypothesize that offering CAB-LA as an additional prevention option for MSM already using oral PrEP can mitigate PrEP fatigue over time, resulting in enhanced PrEP use and increased coverage of at-risk sexual intercourses.

This study is designed as a pragmatic, open-label, multicenter, parallel-group, randomized controlled clinical trial aiming to enroll MSM using PrEP for at least 6 months. Participants will be randomly assigned in a 1:1 ratio to remain on their current oral PrEP regimen with daily and/or on-demand TDF/FTC (Control arm) or to switch to a CAB-LA based PrEP (Intervention arm). Participants will be enrolled over 6 months and followed for two years. The trial will be conducted at 9 clinical sites in the Paris region. The primary objective of the study will be to compare the sustained PrEP use over time among participants randomized to CAB-LA vs. oral TDF/FTC based PrEP at Months 12 and 24. The main secondary objectives will aim to evaluate the PrEP coverage of at-risk sexual intercourses, the change from baseline in sexual risk behaviors, the safety of the drugs, and the HIV incidence.

The study protocol includes three ancillary studies:

  • Social science: Focus groups will be conducted among study participants to investigate their perceptions of CAB-LA, motivations for using it, adherence and persistence, changes in HIV risk perception, and impact on sexual satisfaction. Additionally, this study will assess healthcare providers' perceptions, barriers, and facilitators regarding CAB-LA implementation for PrEP.
  • Rectal tissue HIV-1 permissibility: This study aims to evaluate the protection from HIV-1 at different time points after oral and injectable CAB initiation using a model of Ex-vivo rectal tissue and PBMCs infection with HIV-1.
  • Medico-economics analysis: The main objective of this study is to establish cost-effectiveness performance benchmarks for CAB-LA in HIV PrEP.
Conditions
Prevention
Being tested
Cabotegravir Tablets, for oral use., Cabotegravir Extended-Release Injectable Suspension, for intramuscular use., Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use, Rectal Biopsies
Keywords
HIV pre-exposure prophylaxis, PrEP, MSM, Long-acting injectable, cabotegravir, TDF/FTC, Persistence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cabotegravir Tablets, for oral use.Drug

    Also called VOCABRIA

    Participants randomly assigned to the cabotegravir arm will be instructed to take by mouth a single tablet of cabotegavir 30mg once daily for four weeks.

  • Cabotegravir Extended-Release Injectable Suspension, for intramuscular use.Drug

    Also called APRETUDE

    Participants will receive 600mg (3mL) CAB LA injections intramuscularly at Month 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24. The injections will be performed in the gluteal muscle by trained healthcare providers at study sites.

  • Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral useDrug

    Also called TRUVADA

    • Daily regimen: a single tablet of TDF/FTC every 24 hours, regardless of sexual activity. If PrEP was stopped, resume with two pills of TDF/FTC followed by one pill every 24 hours.
    • On-demand regimen: a loading dose of two pills of TDF/FTC 2 to 24 hours before sexual intercourse, a third pill 24 hours after the first drug intake and a fourth pill 24 hours later. In case of daily sexual intercourse, participants will be instructed to take one pill per day until the last sexual intercourse, then to take the two post-exposure pills. If the last dose of TDF/FTC was taken less than one week prior, a leading dose with a single pill of TDF/FTC is sufficient.

  • Rectal BiopsiesProcedure or surgery

    This intervention concerns only participants involved in the rectal tissue HIV-1 permissibility sub-study.

    The proctologist collects ten rectal biopsies at different time points before and after PrEP initiation according to the randomization arm.

Study groups in NCT06273943
Study groupRoleWhat they receive
Oral PrEP with daily or on-demand TDF/FTCActive comparatorParticipants randomly assigned to the oral PrEP regimen will be instructed to take a single dose combination of TDF 300 mg + FTC 200 mg (TDF/FTC), either daily or on-demand, according to their preferences.
Receives: Drug: Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use; Procedure: Rectal Biopsies
Long-acting injectable PrEP with cabotegavirExperimentalParticipants assigned to the cabotegravir group will initially take a 30mg oral tablet of cabotegravir daily for a four-week period. Following this initial phase, they will receive 13 intramuscular injections of 600mg (3mL) long-acting injectable cabotegravir (CAB-LA) administered every two months after an initial loading dose given one month after the last oral tablet.
Receives: Drug: Cabotegravir Tablets, for oral use.; Drug: Cabotegravir Extended-Release Injectable Suspension, for intramuscular use.; Procedure: Rectal Biopsies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm.

    Measured: At Month 12

Secondary outcomes (19)

  1. Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm.

    Measured: At Month 24

  2. Number of participants with missing follow-up visits, temporary PrEP discontinuation, permanent PrEP discontinuation, switching to another PrEP regimen, study discontinuation, lost to follow-up.

    Measured: At 12 and 24 Months.

  3. Number of participants whose last condomless anal sexual intercourse was not covered by PrEP.

    Measured: At each study visits.

  4. Number of condomless anal sexual intercourse in the month prior to each study visit.

    Measured: At each study visits.

  5. Number of sexual partners in the last 3 months.

    Measured: At baseline, 6, 12, 18 and 24 months

  6. Mean PrEP satisfaction score based on study arm.

    Measured: At baseline, 6, 12, 18 and 24 months.

  7. Number of participants with syphilis, chlamydiae, and/or gonorrhea infection.

    Measured: From Day 1 up to end of study.

  8. Number of participants with Grade 2 or higher clinical or laboratory drug-related adverse events at any time during the study.

    Measured: From Day 1 up to end of study.

  9. Change from baseline in body weight (kg).

    Measured: At Months 12 and 24.

  10. Change from baseline in lipids

    Fasting total Cholesterol (mmol/L), LDL cholesterol (mmol/L), HDL cholesterol (mmol/L).

    Measured: At Months 12 and 24.

  11. Change from baseline in the insulin resistance index (HOMA-IR).

    HOMA-IR : [fasting glucose (mmol/L) × fasting insulin (μmol/L)/22.5]

    Measured: At Months 12 and 24.

  12. Number and severity of injection site reaction.

    Measured: After 12 and 24 Months.

  13. Cabotegravir concentration in plasma and tenofovir diphosphate and emtricitabine triphosphate concentration in dried blood spots.

    Measured: At baseline, 6, 12, 18 and 24 months.

  14. Number of participants with new HIV infection.

    Measured: From Day 1 up to end of study.

  15. Number of participants who used psychoactive drugs in the last 3 months

    Measured: At baseline, 6, 12, 18 and 24 months.

  16. Score of quality of life measured by the EuroQol-5D questionnaire

    The possible range of scores is 0 to 100%, with the higher scores indicating better outcome.

    Measured: At baseline, 6, 12, 18 and 24 months.

  17. Depression score assessed with the Center for Epidemiologic Studies Depression Scale (CES-D).

    The possible range of scores is 0 to 60, with the higher scores indicating worse outcome.

    Measured: At baseline,12, and 24 months.

  18. Self-esteem score assessed with the Rosenberg scale.

    The scale ranges from 0 to 30, with the higher score indicating a better outcome.

    Measured: At baseline,12, and 24 months.

  19. Number and nature of uses of community peer support and therapeutic patient education.

    Measured: At baseline, 6, 12, 18 and 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion30 Oct 2025 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1 ratio to remain on their current oral PrEP regimen with daily and/or on-demand TDF/FTC (Control arm) or to switch to a CAB-LA based PrEP (Intervention arm).
Masking
None (open label)
Enrolment
322 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06273943
Sponsor's protocol ID
ANRS 0410s CABOPrEP
Other IDs
2024-510678-25
Acronym
CABOPrEP
Status last verified
Feb 2024
First submitted
7 Feb 2024
Last updated
23 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cabotegravir Tablets, for oral use., Cabotegravir Extended-Release Injectable Suspension, for intramuscular use. and Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use in people with Prevention, run by ANRS, Emerging Infectious Diseases at 8 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 28 inclusion and 0 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 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Geoffroy LIEGEON, Dr (312-483-6988 ext. +1, geoffroy.liegeon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm. (time frame: At Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06273943.

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 23 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in