APRETUDE for HIV Prevention

(EBONI Trial)

Recruiting at 16 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

66 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.

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 data supports the idea that APRETUDE for HIV Prevention is an effective drug?

The available research shows that APRETUDE, also known as Cabotegravir, is effective for preventing HIV. It is a long-acting injectable drug that reduces the risk of getting HIV when taken before exposure. Studies have shown that it is safe and well-tolerated in people who do not have HIV. One of the key benefits of APRETUDE is that it can be given as an injection every few weeks, which means people don't have to remember to take a pill every day. This can help people stick to their prevention plan better than daily pills. Compared to other treatments, APRETUDE's long-acting nature may improve adherence, making it a promising option for HIV prevention. ^{1 2 3 4 5}

What data supports the effectiveness of the drug APRETUDE for HIV prevention?

Research shows that Cabotegravir (Apretude) is effective as a long-acting injectable drug for preventing HIV-1 infection in people who are at risk but currently HIV-negative. It works by reducing the risk of sexually acquired HIV-1 infection, and studies have demonstrated its safety and potential to improve adherence due to less frequent dosing. ^{1 2 3 4 5}

What safety data is available for Cabotegravir (Apretude) in HIV prevention?

Cabotegravir (Apretude) has been evaluated in various studies for its safety as an HIV-1 integrase strand transfer inhibitor used in pre-exposure prophylaxis (PrEP). In phase 1 trials, it was well tolerated both alone and in combination with rilpivirine. The ECLAIR trial also explored patient satisfaction and acceptability of cabotegravir as a long-acting injectable suspension for HIV-1 PrEP. Additionally, its safety and efficacy have been reviewed in the context of its use with rilpivirine for HIV-1 treatment. ^{1 2 4 6 7}

Is Cabotegravir (Apretude) safe for humans?

Cabotegravir (Apretude) has been generally well tolerated in clinical trials, both alone and in combination with other medications, for HIV prevention and treatment. ^{1 2 4 6 7}

Is the drug Cabotegravir (Apretude) a promising option for preventing HIV?

Yes, Cabotegravir (Apretude) is a promising drug for preventing HIV. It is an injectable medication that can be taken less frequently than daily pills, which makes it easier for people to stick to their prevention plan. Studies have shown it to be effective in reducing the risk of getting HIV, and it is considered more effective and acceptable than some other oral medications. ^{1 4 5 8 9}

What makes the drug Apretude unique for HIV prevention?

Apretude (cabotegravir) is unique because it is a long-acting injectable drug used for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection, reducing the need for daily pills and potentially improving adherence. ^{1 4 5 8 9}

Research Team

GSK Clinical Trials

Principal Investigator

ViiV Healthcare

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 (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 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]

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]

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 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) 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cabotegravir (Apretude) for Pre-exposure Prophylaxis for HIV Type 1 Infection. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Cabotegravir: its potential for antiretroviral therapy and preexposure prophylaxis. [2020]

3. United States 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Satisfaction and acceptability of cabotegravir long-acting injectable suspension for prevention of HIV: Patient perspectives from the ECLAIR trial. [2020]

5. England pubmed.ncbi.nlm.nih.gov

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

6. United States 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. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Long-acting preexposure prophylaxis in low- and middle-income countries: key considerations for implementation. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Cabotegravir-Global Access to Long-Acting Pre-exposure Prophylaxis for HIV. [2023]