A Phase 3 interventional study of Cabotegravir Tablets, for oral use. and Cabotegravir Extended-Release Injectable Suspension, for intramuscular use. in Prevention, sponsored by ANRS, Emerging Infectious Diseases. Not yet recruiting at 8 sites in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 3, Interventional, and Prevention
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.
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:
ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria
Non-inclusion criteria
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
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
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
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
* 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
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.
Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm.
Time frame: At Month 12
Number of protocol visits completed with a documented PrEP prescription aligned with the randomization arm.
Time frame: 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.
Time frame: At 12 and 24 Months.
Number of participants whose last condomless anal sexual intercourse was not covered by PrEP.
Time frame: At each study visits.
Number of condomless anal sexual intercourse in the month prior to each study visit.
Time frame: At each study visits.
Number of sexual partners in the last 3 months.
Time frame: At baseline, 6, 12, 18 and 24 months
Mean PrEP satisfaction score based on study arm.
Time frame: At baseline, 6, 12, 18 and 24 months.
Number of participants with syphilis, chlamydiae, and/or gonorrhea infection.
Time frame: From Day 1 up to end of study.
Number of participants with Grade 2 or higher clinical or laboratory drug-related adverse events at any time during the study.
Time frame: From Day 1 up to end of study.
Change from baseline in body weight (kg).
Time frame: At Months 12 and 24.
Change from baseline in lipids
Fasting total Cholesterol (mmol/L), LDL cholesterol (mmol/L), HDL cholesterol (mmol/L).
Time frame: At Months 12 and 24.
Change from baseline in the insulin resistance index (HOMA-IR).
HOMA-IR : \[fasting glucose (mmol/L) × fasting insulin (μmol/L)/22.5\]
Time frame: At Months 12 and 24.
Number and severity of injection site reaction.
Time frame: After 12 and 24 Months.
Cabotegravir concentration in plasma and tenofovir diphosphate and emtricitabine triphosphate concentration in dried blood spots.
Time frame: At baseline, 6, 12, 18 and 24 months.
Number of participants with new HIV infection.
Time frame: From Day 1 up to end of study.
Number of participants who used psychoactive drugs in the last 3 months
Time frame: At baseline, 6, 12, 18 and 24 months.
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.
Time frame: At baseline, 6, 12, 18 and 24 months.
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.
Time frame: At baseline,12, and 24 months.
Self-esteem score assessed with the Rosenberg scale.
The scale ranges from 0 to 30, with the higher score indicating a better outcome.
Time frame: At baseline,12, and 24 months.
Number and nature of uses of community peer support and therapeutic patient education.
Time frame: At baseline, 6, 12, 18 and 24 months.
Plan to share: No
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ANRS, Emerging Infectious Diseases