New CAB LA Formulation for HIV Prevention

Recruiting at 22 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: ViiV Healthcare

Must not be taking: Antiretrovirals, Interferon

Disqualifiers: HIV, Hepatitis B, Liver disease, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.

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.

What data supports the effectiveness of the drug Cabotegravir Long-Acting for HIV prevention?

Clinical trials have shown that long-acting injectable cabotegravir (CAB-LA) is safe, highly effective, and well-accepted for preventing HIV, with its effectiveness surpassing other HIV prevention methods like condoms and oral medications. ^{1 2 3 4 5}

Is the new CAB LA formulation for HIV prevention safe for humans?

Long-acting injectable cabotegravir (CAB-LA) has been shown to be safe in clinical trials for HIV prevention, with participants generally tolerating it well. ^{1 2 3 4 6}

How is the drug Cabotegravir Long-Acting (CAB-LA) unique for HIV prevention?

Cabotegravir Long-Acting (CAB-LA) is unique because it is an injectable form of HIV prevention that is administered less frequently than daily oral pills, making it easier for people who struggle with daily medication adherence. It provides a long-acting option for pre-exposure prophylaxis (PrEP), which can help fill gaps in current HIV prevention strategies. ^{1 2 3 4 6}

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Cabotegravir Long-Acting (Anti-retroviral)

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.

Participant Groups

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

Findings from Research

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]

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) 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]

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]

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]

References

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

Long-acting injectable cabotegravir for the prevention of HIV infection. [2023]

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

Cabotegravir: The First Long-Acting Injectable for HIV Preexposure Prophylaxis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of long-acting injectable cabotegravir as preexposure prophylaxis to prevent HIV acquisition. [2023]

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

Long-acting injectable cabotegravir for PrEP: A game-changer in HIV prevention? [2023]

5. Switzerland 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. [2023]

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

The Potential Impact of Long-Acting Cabotegravir for HIV Prevention in South Africa: A Mathematical Modeling Study. [2022]