APRETUDE for HIV Prevention

(EBONI Trial)

No longer recruiting at 18 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: ViiV Healthcare

Must be taking: PrEP

Disqualifiers: HIV positive, Male, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 13 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of Cabotegravir (CAB) in preventing HIV. It tests various support methods for patients and healthcare providers to use this medication effectively. The study includes HIV-negative participants who are African American/Black females at birth or self-identified transgender females. Participants will receive CAB as an injection, with an option for tablets, and will be divided into groups to determine which support methods are most effective. The trial aims to identify factors that help or hinder the successful use of CAB for HIV prevention. As a Phase 4 trial, it involves an FDA-approved treatment, focusing on how CAB can benefit more patients effectively.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your healthcare provider for guidance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your healthcare provider.

What is the safety track record for these treatments?

Research has shown that APRETUDE, an injectable form of cabotegravir, is generally well tolerated. In studies with over 2,000 participants, the most common side effects were mild, including pain or redness at the injection site, headaches, diarrhea, and tiredness. These effects were usually not serious enough to stop treatment.

The cabotegravir tablets, used as a first step before starting injections, have similar safety data, exhibiting the same mild side effects as the injections.

Extensive studies have established the safety of both the injections and tablets. The FDA has approved APRETUDE to help prevent HIV in people at risk, which adds confidence in its safety when used as directed. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Cabotegravir for HIV prevention because it offers a new approach compared to traditional daily oral PrEP options like Truvada and Descovy. Unlike these standard treatments, Cabotegravir can be administered as a long-acting injection, potentially every two months, which could greatly improve adherence and convenience for users. Additionally, Cabotegravir tablets can be used as an oral lead-in before transitioning to the injectable form, allowing for a smoother adaptation and monitoring of any side effects. This flexibility and the reduced frequency of dosing make it a promising alternative for those at risk of HIV.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

Research has shown that Cabotegravir, administered as APRETUDE injections, effectively prevents HIV. Studies involving nearly 4,000 people found it to be more than 99% effective in real-world situations, making it a reliable choice for HIV prevention. In this trial, participants in the various treatment arms will receive APRETUDE injections and may also receive optional Cabotegravir tablets as an oral lead-in. Cabotegravir stops the virus from multiplying, preventing it from spreading in the body. This long-lasting treatment offers an alternative to daily pills, providing more convenience and peace of mind for users. ^{6 7 8 9 10}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

ViiV Healthcare

Are You a Good Fit for This Trial?

This trial is for Black cisgender and transgender women over 18 years old who are HIV negative, have never taken Cabotegravir (CAB) before, and can consent to the study. They must be considered appropriate candidates for CAB pre-exposure prophylaxis (PrEP) by their healthcare provider.

Inclusion Criteria

I am a female by birth or identify as a transgender female.

HIV negative at screening (Type of HIV-1 test is per standard of care)

I have never taken oral CAB or received CAB LA injections.

Exclusion Criteria

A participant of concurrent interventional clinical or implementation science study at any time during the study

I identify as a cisgender or transgender male.

HIV indeterminate or positive test result during screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive APRETUDE injection and could receive optional Cabotegravir tablets as oral lead-in (OLI). Implementation strategies are evaluated.

13 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• APRETUDE
• Cabotegravir tablet

Trial Overview

The study tests how well strategies work for delivering APRETUDE (Cabotegravir tablet), a medication used to prevent HIV infection. It looks at how suitable, adoptable, feasible, faithful to plan, and acceptable these strategies are in real-world settings.

How Is the Trial Designed?

Group I: Enhanced Implementation (EI) Experimental Treatment 2 Interventions

PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as OLI. The EI arm will receive all components of SI arm and additional provider-focused implementation strategies. Provider-focused strategies will include a patient-provider communication tool, Provider Education, and enhanced tool kit materials.

Group II: Enhanced Collaborative Implementation (ECI) Experimental Treatment 2 Interventions

PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as OLI. The ECI arm will involve implementation strategies to support patient activation and provider awareness. Clinics randomized to ECI will receive all components of SI and additional implementation strategies to support patient activation and ensure provider awareness. ECI strategies will include a patient information and product resources and peer support.

Group III: Standard Implementation (SI) Active Control 2 Interventions

PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as oral lead in (OLI). The SI arm receives the standard toolkits that are anticipated to be available for APRETUDE that includes information resource for PSPs and SSPs.

Cabotegravir tablet is already approved in European Union, United States for the following indications:

Approved in European Union as Vocabria for:

• HIV-1 infection in combination with rilpivirine injection

Approved in United States as Apretude for:

• Pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV

Who Is Running the Clinical Trial?

ViiV Healthcare

Lead Sponsor

Trials

379

Recruited

479,000+

Founded

2009

Headquarters

London, England, UK

Known For

HIV Research

Top Products

- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

Published Research Related to This Trial

Cabotegravir (Apretude) is an effective extended-release injectable medication used as pre-exposure prophylaxis (PrEP) to significantly reduce the risk of acquiring HIV-1 in HIV-negative individuals at risk.

It is approved for use in adults and adolescents who weigh at least 35 kg (77 lb), highlighting its targeted application for those most vulnerable to sexually transmitted HIV-1.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir (Apretude) for Pre-exposure Prophylaxis for HIV Type 1 Infection. El-Haddad, A., Erlich, D.[2023]

Cabotegravir long-acting injectable (CAB LA) was found to be well tolerated among participants, with a high completion rate of injections (80% in Cohort 1 and 92% in Cohort 2), despite common injection site reactions (ISRs) that were mostly mild to moderate.

The study demonstrated that CAB LA 600 mg administered every 8 weeks successfully maintained drug levels above effective thresholds in 95% of participants, supporting its potential for HIV prevention and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial. Landovitz, RJ., Li, S., Grinsztejn, B., et al.[2023]

Long-acting cabotegravir (LA-CAB) has shown promising efficacy in preventing HIV acquisition in phase II/III studies, making it a potential key tool in HIV prevention efforts.

To successfully implement LA-CAB in low- and middle-income countries, it is crucial to address various contextual factors, optimize service delivery models, and consider the cost, which will significantly influence its accessibility and uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-acting preexposure prophylaxis in low- and middle-income countries: key considerations for implementation. Kaewpoowat, Q., Chariyalertsak, S., Phanuphak, N., et al.[2023]

Cabotegravir, a new integrase strand transfer inhibitor, shows promise as a long-acting injectable treatment for HIV, potentially improving adherence to pre-exposure prophylaxis (PrEP) and treatment due to reduced dosing frequency.

Clinical studies indicate that cabotegravir can be effectively used alone or in combination with other anti-HIV agents like rilpivirine, allowing for formulations that require administration every 4 weeks or less, which may enhance patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A literature review of the patent application publications on cabotegravir - an HIV integrase strand transfer inhibitor. Kovač, L., Časar, Z.[2020]

In the phase IIa ECLAIR study involving 115 healthy men, cabotegravir LA was found to be generally well-tolerated, with a high completion rate of 93% for the injection phase, despite some participants experiencing injection-site pain.

Most participants expressed satisfaction with cabotegravir LA, with 74% preferring it over daily oral cabotegravir, indicating its potential as a favorable alternative for HIV-1 pre-exposure prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction and acceptability of cabotegravir long-acting injectable suspension for prevention of HIV: Patient perspectives from the ECLAIR trial. Murray, MI., Markowitz, M., Frank, I., et al.[2020]

In the LATTE trial involving 243 antiretroviral-naive HIV-1-infected adults, cabotegravir combined with rilpivirine maintained viral suppression effectively, with 82% of patients achieving fewer than 50 copies of HIV-1 RNA at week 48, compared to 71% in the efavirenz group.

Cabotegravir was well tolerated, with fewer treatment-related adverse events leading to withdrawal (3%) compared to efavirenz (15%), suggesting a favorable safety profile for cabotegravir in long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir plus rilpivirine, once a day, after induction with cabotegravir plus nucleoside reverse transcriptase inhibitors in antiretroviral-naive adults with HIV-1 infection (LATTE): a randomised, phase 2b, dose-ranging trial. Margolis, DA., Brinson, CC., Smith, GHR., et al.[2020]

Cabotegravir (CAB) is a promising strand transfer integrase inhibitor being studied for both injectable and oral forms, showing potential for long-lasting treatment with injection intervals of four to eight weeks.

In clinical trials, CAB has demonstrated effective virological activity in combination with rilpivirine and has shown tolerability in humans for preexposure prophylaxis, indicating its potential as a new approach for HIV treatment and prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir: its potential for antiretroviral therapy and preexposure prophylaxis. Stellbrink, HJ., Hoffmann, C.[2020]

Cabotegravir, a new injectable pre-exposure prophylaxis for HIV, has been found to be more effective and acceptable than the oral medication tenofovir/emtricitabine, but its high annual cost of $22,200 poses a significant barrier to access, especially in middle-income countries.

Despite efforts to provide generic versions of cabotegravir in 90 countries, including all African nations, many middle-income countries with rising HIV rates are excluded from this access, affecting 2.4 billion people and highlighting the need for affordable treatment options to combat HIV effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir-Global Access to Long-Acting Pre-exposure Prophylaxis for HIV. Pepperrell, T., Cross, S., Hill, A.[2023]

Cabotegravir (CAB) combined with rilpivirine (RPV) is the first long-acting dual therapy approved for HIV-1 treatment, showing comparable maintenance of viral suppression over 160 weeks with low rates of virological failure.

This regimen offers a convenient alternative to daily oral therapy, as it is administered via intramuscular injections every 4 weeks, with minimal adverse effects and no negative impact on renal or bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir-Rilpivirine: The First Complete Long-Acting Injectable Regimen for the Treatment of HIV-1 Infection. Durham, SH., Chahine, EB.[2022]

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