Long-acting Cabotegravir Formulations in Healthy Adults

Overseen By EU GSK Clinical Trials Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: ViiV Healthcare

Must not be taking: Anticoagulants, Tobacco, Alcohol, others

Disqualifiers: Cardiovascular, Respiratory, Hepatic, Renal, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 52 weeks

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (PK) profiles of two different cabotegravir formulations in healthy adult participants. The study will initially start with the assessment of Cabotegravir Formulation F. Once the clinical batch of Cabotegravir Formulation G is available, this formulation will be assessed.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on chronic anti-coagulation therapy (except low-dose aspirin), you may not be eligible to participate.

Is long-acting cabotegravir safe for humans?

Long-acting cabotegravir has a manageable safety profile and is generally considered safe for use in humans, with fewer kidney-related side effects compared to some other HIV prevention medications. ^{1 2 3 4 5}

How is the drug Cabotegravir unique compared to other treatments?

Cabotegravir is unique because it is a long-acting injectable drug that can be administered every 2 months, unlike many HIV treatments that require daily oral doses. This makes it easier for people to maintain their treatment without the need for daily medication adherence. ^{3 4 5 6 7}

What data supports the effectiveness of the drug Cabotegravir Formulation F and G?

Long-acting cabotegravir has shown promise in treating and preventing HIV, as it can be administered less frequently than daily pills, making it easier for people to stick to their treatment. Studies have demonstrated its effectiveness and safety when used with another drug, rilpivirine, for HIV treatment. ^{5 8 9 10 11}

Are You a Good Fit for This Trial?

Healthy adults over 40 kg and BMI of 18-32, not pregnant or breastfeeding, with no major health issues. Must test negative for COVID-19 on admission day, agree to use effective contraception, and have no history of drug abuse or high-risk behaviors for HIV infection.

Inclusion Criteria

Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

I was assigned female at birth, am not pregnant or breastfeeding, and meet one of the required conditions.

I tested negative for COVID-19 on the day I was admitted.

Exclusion Criteria

My blood pressure is not normal.

I have a genetic blood clotting disorder like haemophilia or VWD.

History of or on-going high-risk behaviors that, in the opinion of the investigator, may put the participant at increased risk for HIV infection including, but not limited to, participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cabotegravir Formulation F initially, followed by Cabotegravir Formulation G once available

Up to 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cabotegravir Formulation F
• Cabotegravir Formulation G

Trial Overview The trial is testing two different long-acting formulations of Cabotegravir (Formulation F followed by G) in healthy participants to assess their safety, tolerability, and how the body processes them.

How Is the Trial Designed?

Group I: Part B: Participants receiving Cabotegravir Formulation G Experimental Treatment 1 Intervention

Group II: Part A: Participants receiving Cabotegravir Formulation F Experimental Treatment 1 Intervention

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 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]

In a study of 321 adults with HIV receiving the CAB + RPV LA injectable regimen, 90% of continuation injections were administered on time, indicating strong adherence to the injection schedule.

Among those who started with a viral load < 50 copies/mL, 95% remained undetectable and 99% were suppressed at their last measurement, demonstrating the high efficacy of CAB + RPV LA in maintaining virologic control in routine clinical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir + Rilpivirine Long-Acting Injections for HIV Treatment in the US: Real World Data from the OPERA Cohort. Sension, MG., Brunet, L., Hsu, RK., et al.[2023]

Long-acting cabotegravir is more effective than daily oral tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) in preventing HIV infection, with a significantly lower risk of infection (HR = 0.22).

Cabotegravir also shows a better safety profile, with less frequent decreases in kidney function (creatinine clearance) compared to TDF-FTC, although it may cause more injection site reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of long-acting cabotegravir versus oral tenofovir disoproxil fumarate-emtricitabine as HIV pre-exposure prophylaxis: A systematic review and meta-analysis. Chen, X., Li, J., Kou, L., et al.[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]

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]

In a Phase 2b study involving 97 adults living with HIV-1, the long-acting formulation of cabotegravir and rilpivirine (CAB+RPV) administered every 2 months successfully maintained virologic suppression, with no participants showing HIV-1 RNA levels above 50 copies/ml after 12 months.

The long-acting CAB+RPV treatment had a favorable safety profile, with no new safety concerns identified, and 88% of participants preferred this regimen over their previous daily oral treatment, indicating high treatment satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy. Mills, A., Richmond, GJ., Newman, C., et al.[2023]

Citations

1. 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]

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

Long-acting injectable therapy: an emerging paradigm for the treatment of HIV infection. [2021]

3. Italy pubmed.ncbi.nlm.nih.gov

Long-acting agents for HIV infection: biological aspects, role in treatment and prevention, and patient's perspective. [2017]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Cabotegravir + Rilpivirine Long-Acting Injections for HIV Treatment in the US: Real World Data from the OPERA Cohort. [2023]

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

Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With Human Immunodeficiency Virus Type 1 Infection: 5-Year Results From the LATTE-2 Study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of long-acting cabotegravir versus oral tenofovir disoproxil fumarate-emtricitabine as HIV pre-exposure prophylaxis: A systematic review and meta-analysis. [2023]

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

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

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

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

9. England pubmed.ncbi.nlm.nih.gov

Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy. [2023]

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

Formulation and pharmacology of long-acting cabotegravir. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial. [2022]