New CAB LA Formulation for HIV Prevention

Not currently recruiting at 24 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: ViiV Healthcare

Must not be taking: Antiretrovirals, Interferon

Disqualifiers: HIV, Hepatitis B, Liver disease, 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

Compensation: Varies

Number of Visits: 1

Duration: 29 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new long-acting form of Cabotegravir, administered every four months, to evaluate its safety and effectiveness in preventing HIV. It targets individuals at risk of HIV, such as those who have had unprotected sex in the past six months. Participants must be generally healthy and have a negative HIV test. The trial aims to offer a more convenient option for HIV prevention. Those who meet these criteria and wish to contribute to HIV prevention research may find this trial suitable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires participants who have been taking oral PrEP to stop it within 10 days before starting the study. For other medications, the protocol does not specify, but participants should discuss their current medications with the study team to ensure they are not on any protocol-prohibited medications.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Previous studies have shown that cabotegravir long-acting (CAB-LA) is safe and well-tolerated for preventing HIV. Research indicates it is effective and acceptable, particularly in stopping the spread of HIV. Reports show that CAB-LA reduces the risk of acquiring HIV by 79% in various situations.

The treatment is generally safe for diverse groups, including teenage girls and cisgender men. While side effects may occur, they are typically mild and manageable. Its approval for HIV prevention further supports its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HIV?

Unlike other treatments for HIV prevention, which often require frequent daily dosing, the new cabotegravir long-acting (CAB LA) formulation is administered through injections just every few months. This less frequent dosing schedule can significantly enhance convenience and adherence, making it a game-changer for individuals at risk of HIV. Researchers are excited about this treatment because it combines the proven efficacy of cabotegravir with a new long-acting formulation, potentially offering a more manageable and sustainable prevention option for people worldwide.

What evidence suggests that this new CAB LA formulation is effective for HIV prevention?

Research has shown that Cabotegravir Long-Acting (CAB LA) is highly effective at preventing HIV. In real-world studies, CAB LA demonstrated over 99% effectiveness, with no participants contracting HIV during the follow-up period. Another study found that CAB LA reduced HIV infections by 79% across different groups and was 89% more effective than another common HIV prevention method. These results highlight CAB LA’s strong potential as a reliable option for preventing HIV. Participants in this trial will receive a new formulation of CAB LA, with injections scheduled at specific intervals to assess its effectiveness and safety. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals at risk of HIV-1 acquisition who are interested in a new form of pre-exposure prophylaxis (PrEP). Participants should be healthy and willing to receive injections every four months. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information.

Inclusion Criteria

I use birth control methods suitable for my gender, whether I was assigned male or female at birth or am transgender.

Participants must have a nonreactive HIV test at Screening and enrollment

I weigh at least 35 kg.

Exclusion Criteria

Reactive or positive HIV test results at Screening or Enrollment

I have a history of liver cirrhosis, with or without hepatitis.

Co-enrollment in other interventional research studies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lead-in injections of cabotegravir LA during month one and injections of a new formulation of CAB LA at Month 3, Month 5, and every 4 months thereafter to Month 29

29 months

Injections at Day 1, Months 1, 3, 5, 9, 13, 17, 21, 25, 29

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Cabotegravir Long-Acting

Trial Overview The study is testing a new formulation of Cabotegravir (CAB) that is administered as an injection once every four months. The focus is on understanding how the body processes the drug (pharmacokinetics), its safety, and how well participants tolerate it over time.

How Is the Trial Designed?

Group I: CAB Group Experimental Treatment 2 Interventions

Participants receive lead-in injections comprising cabotegravir LA during month one and injections of a new formulation of CAB LA at Month 3, Month 5 and every 4 months thereafter to Month 29.

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

Long-acting injectable cabotegravir (CAB-LA) is a promising new option for HIV prevention, showing high safety and efficacy in clinical trials, particularly for individuals struggling with adherence to oral PrEP.

Despite its potential, challenges such as breakthrough infections, logistical issues, and the need for comprehensive implementation strategies must be addressed to fully integrate CAB-LA into HIV prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-acting injectable cabotegravir for PrEP: A game-changer in HIV prevention? Liegeon, G., Ghosn, J.[2023]

Long-acting cabotegravir (CAB LA) could significantly reduce new HIV infections in South Africa, potentially averting over 15% of new cases if administered to 10% of the adult population from 2023 to 2050.

Targeting CAB LA to high-risk groups, especially young women, would enhance its effectiveness, requiring fewer person-years of treatment to prevent each new infection compared to a broader population approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential Impact of Long-Acting Cabotegravir for HIV Prevention in South Africa: A Mathematical Modeling Study. Smith, JA., Garnett, GP., Hallett, TB.[2022]

Cabotegravir (CAB-LA) is the first long-acting injectable medication approved for HIV preexposure prophylaxis (PrEP), showing superior efficacy compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in preventing HIV-1 infection among high-risk individuals, as demonstrated in two phase 3 trials that were stopped early due to its effectiveness.

While CAB-LA is generally well-tolerated, with injection site reactions being the most common side effect, it may be particularly beneficial for individuals who struggle with adherence to daily oral medications, although it is more expensive than generic options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir: The First Long-Acting Injectable for HIV Preexposure Prophylaxis. Durham, SH., Milam, A., Waer, D., et al.[2023]

Long-acting injectable cabotegravir (CAB-LA) significantly reduces the risk of HIV acquisition by 79% compared to oral PrEP, based on a systematic review of four multisite randomized controlled trials involving diverse populations.

While CAB-LA shows high efficacy and similar rates of adverse events compared to other PrEP methods, there is a potential risk of integrase strand transfer inhibitor (INSTI) resistance in individuals who may have acute HIV infection at the start of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of long-acting injectable cabotegravir as preexposure prophylaxis to prevent HIV acquisition. Fonner, VA., Ridgeway, K., van der Straten, A., et al.[2023]

Long-acting injectable cabotegravir (CAB LA) for HIV preexposure prophylaxis (PrEP) has shown promising results in phase 2 studies, with effective dosing at 8-week intervals that maintains target drug levels in both men and women.

CAB LA has a favorable safety profile, requiring no dose adjustments for patients with liver or kidney issues and showing minimal drug-drug interactions, making it a potentially effective alternative for individuals who struggle with daily pill adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-acting injectable cabotegravir for the prevention of HIV infection. Clement, ME., Kofron, R., Landovitz, RJ.[2023]

Injectable cabotegravir (CAB-LA) has shown to be the most effective HIV prevention method compared to other interventions like condoms and oral PrEP, highlighting its potential as a game changer in HIV prevention.

For CAB-LA to be successfully rolled out, it is crucial to ensure affordability, create a guaranteed market size, and integrate it into healthcare systems, which requires collaboration among manufacturers, funders, and governments, especially in high-prevalence areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What will it take for an injectable ARV to change the face of the HIV epidemic in high-prevalence countries? Considerations regarding drug costs and operations. Meyer-Rath, G., Jamieson, L., Pillay, Y.[2023]

Citations

1. viivhealthcare.com viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/october/real-world-studies-for-apretude/

Apretude: >99% effective in real-world HIV PrEP studies Findings from the cohort showed that there were zero HIV diagnoses identified during follow-up among participants taking CAB LA for PrEP. Eighty ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10090368/

Safety and efficacy of long-acting injectable cabotegravir as ... Our review suggests that CAB-LA is safe and highly effective for HIV prevention across studied populations and settings, demonstrating a 79% reduction in ...

3. who.int who.int/news/item/09-11-2020-trial-results-reveal-that-long-acting-injectable-cabotegravir-as-prep-is-highly-effective-in-preventing-hiv-acquisition-in-women

Trial results reveal that long-acting injectable cabotegravir ... While both methods were highly effective at preventing HIV acquisition, long-acting cabotegravir was 89% (95% CI 68-96%) more effective than FTC ...

4. thelancet.com thelancet.com/journals/lanhiv/article/PIIS2352-3018(23)00261-8/fulltext

Efficacy and safety of long-acting cabotegravir compared ... HPTN 083 and 084 demonstrated 66% and 89% reductions in incident HIV infections for long-acting compared with daily oral PrEP in their ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352301825001699

Dynamic choice HIV prevention with long-acting injectable ... Offering structured PrEP and PEP choice including long-acting cabotegravir and enabling risk-informed use could reduce HIV incidence by a third ...

6. thelancet.com thelancet.com/journals/lanhiv/article/PIIS2352-3018(24)00310-2/fulltext

Safety, tolerability, and acceptability of long-acting ... Long-acting injectable cabotegravir is a safe, tolerable, and acceptable option for the prevention of HIV in adolescent girls. Our study ...

7. who.int who.int/publications/i/item/9789240054097

Guidelines on long-acting injectable cabotegravir for HIV ... CAB-LA is an injectable form of pre-exposure prophylaxis (PrEP) that has been shown to be highly effective at reducing the risk of HIV ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04692077

Study Details | NCT04692077 | Safety, Tolerability and ... This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an ...

9. prepwatch.org prepwatch.org/products/injectable-cab-for-prep/

Injectable Cabotegravir for PrEP Does not prevent any sexually transmitted infections other than HIV. Does not prevent pregnancy. Safety. Found to be safe and effective for cisgender men and ...