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

NCT06273943 | Not Yet Recruiting Phase 3

• 2 other identifiers: ANRS 0410s CABOPrEP2024-510678-25
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 8

Brief 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 behaviors.

Conditions

Prevention

Keywords

HIV pre-exposure prophylaxis; PrEP; MSM; Long-acting injectable; cabotegravir; TDF/FTC; Persistence

Outcome Measures

Primary Outcomes (1)

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

  At Month 12

Secondary Outcomes (19)

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

  At Month 24

• 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.

  At 12 and 24 Months.

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

  At each study visits.

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

  At each study visits.

• Number of sexual partners in the last 3 months.

  At baseline, 6, 12, 18 and 24 months

Study Arms (2)

Oral PrEP with daily or on-demand TDF/FTC

ACTIVE COMPARATOR

Participants 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.

Drug: Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use; Procedure: Rectal Biopsies

Long-acting injectable PrEP with cabotegavir

EXPERIMENTAL

Participants 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.

Drug: Cabotegravir Tablets, for oral use.; Drug: Cabotegravir Extended-Release Injectable Suspension, for intramuscular use.; Procedure: Rectal Biopsies

Interventions

Cabotegravir Tablets, for oral use. DRUG

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.

Also known as: VOCABRIA

Long-acting injectable PrEP with cabotegavir

Cabotegravir Extended-Release Injectable Suspension, for intramuscular use. DRUG

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.

Also known as: APRETUDE

Long-acting injectable PrEP with cabotegavir

Tenofovir disoproxil/Emtricitabine 300mg/200mg fixed-dose combination tablets, for oral use DRUG

* 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.

Also known as: TRUVADA

Oral PrEP with daily or on-demand TDF/FTC

Rectal Biopsies PROCEDURE

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.

Long-acting injectable PrEP with cabotegavir; Oral PrEP with daily or on-demand TDF/FTC

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender Men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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).

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (8)

Hôpital Hôtel Dieu

Paris, Île-de-France Region, 75004, France

Location

Hôpital Lariboisière

Paris, Île-de-France Region, 75010, France

Location

Hôpital Saint Louis

Paris, Île-de-France Region, 75010, France

Location

Hôpital Saint Antoine

Paris, Île-de-France Region, 75012, France

Location

Hôpital La Pitié Salpêtrière

Paris, Île-de-France Region, 75013, France

Location

Hôpital Necker

Paris, Île-de-France Region, 75015, France

Location

Hôpital Bichat

Paris, Île-de-France Region, 75018, France

Location

Hôpital Tenon

Paris, Île-de-France Region, 75020, France

Location

MeSH Terms

Interventions

cabotegravir; Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Jean-Michel Molina, Professor

  Saint-Louis Hospital, Paris, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoffroy LIEGEON, Dr

CONTACT

312-483-6988; geoffroy.liegeon@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 23, 2024
• Study Start: April 1, 2024
• Primary Completion: October 30, 2025
• Study Completion (Estimated): October 30, 2026
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)