Cabotegravir + Lenacapavir for Injection Tolerability

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ViiV Healthcare

Must not be taking: Glucocorticoids, Immune suppressants

Disqualifiers: Cardiovascular disease, Liver disease, Cancer, 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: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two long-acting injectable treatments, Cabotegravir and Lenacapavir, to assess tolerance, particularly at the injection site. Researchers aim to determine if these injections cause any reactions and whether they are safe. Individuals who are generally healthy and have no history of serious illnesses may be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not clearly specify if you must stop taking your current medications. However, it mentions that participants receiving any protocol-prohibited medication who are unwilling or unable to switch to an alternate medication are excluded. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cabotegravir and lenacapavir, both long-lasting treatments, are generally safe and well-tolerated when given as single doses. Early results from the CLARITY study indicate that these drugs are well-tolerated when used alone. Cabotegravir, an integrase inhibitor, has been taken daily by some individuals without major issues.

Lenacapavir, a capsid inhibitor, works differently. Although it hasn't been widely studied with other long-lasting drugs, using it every six months has been mostly safe. In summary, current research suggests that both cabotegravir and lenacapavir are safe when used individually. However, their safety in new combinations is still under investigation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Cabotegravir and Lenacapavir because these treatments offer a long-acting approach to managing HIV. Unlike current daily antiretroviral pills, these injections are designed to be administered just once every few months, which could significantly improve adherence for patients. Cabotegravir and Lenacapavir also represent a new delivery method, potentially reducing the burden of daily medication and improving quality of life for individuals living with HIV. This shift from daily pills to periodic injections is a game-changer, as it addresses one of the biggest challenges in HIV treatment: ensuring patients consistently take their medication.

What evidence suggests that this trial's treatments could be effective for injection site reactions?

Research has shown that cabotegravir and lenacapavir effectively treat HIV. In this trial, participants will receive either the CAB LA injection followed by LEN LA injections or LEN LA injections followed by the CAB LA injection. Cabotegravir, administered as a long-lasting injection, is more acceptable to patients compared to similar treatments, offering a good option for those who prefer fewer doses. Lenacapavir is highly effective in preventing HIV, especially in women, when used as pre-exposure prophylaxis (PrEP). These long-lasting injections can significantly reduce the frequency of medication, enhancing convenience. Early studies suggest that using these two treatments together could increase their effectiveness and appeal. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults without HIV. It's designed to test the tolerability and acceptability of long-acting injections aimed at preventing HIV infection. Specific eligibility criteria are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

Participants must be overtly healthy as determined by medical evaluation

Participants with significant clinical abnormalities or laboratory parameters outside the reference range may be included after investigator evaluation

Contraceptive use consistent with local regulations

Exclusion Criteria

Positive Treponeme Specific Serologic testing

ALT greater than or equal to 1.5x ULN

Presence of HBsAg or positive hepatitis C antibody test result

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CAB LA injection at Day 1 and LEN LA injection at Day 15, or vice versa

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cabotegravir long-acting
• Lenacapavir long-acting

Trial Overview The study is testing two long-acting injectable drugs: Cabotegravir (CAB) and Lenacapavir (LEN). The focus is on how people tolerate the injections and their reactions at the injection site, along with overall safety outcomes.

How Is the Trial Designed?

Group I: LEN LA/CAB LA Group Experimental Treatment 2 Interventions

Participants receive the LEN LA injections at Day 1 followed by the CAB LA injection at Day 15.

Group II: CAB LA/LEN LA Group Experimental Treatment 2 Interventions

Participants receive the CAB LA injection at Day 1 followed by the LEN LA injections at Day 15.

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

Citations

1. viivhealthcare.com viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/october/viiv-healthcare-clarity-study/

ViiV Healthcare's CLARITY study shows long-acting ... Cabotegravir Injections Are More Acceptable Than Lenacapavir Injections Following a Single Dose: Results From CLARITY, a Randomized Crossover ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12474475/

Real-World Experience with Long-Acting Injectable ... Long-acting (LA) injectables like cabotegravir/rilpivirine (CAB/RPV) offer a promising solution by reducing dosing frequency from daily pills to ...

3. who.int who.int/news/item/26-07-2024-long-acting-injectable-lenacapavir-proves-effective-in-hiv-prevention-for-women

Long-acting injectable lenacapavir proves effective in HIV ... Long-acting injectable lenacapavir as pre-exposure prophylaxis (PrEP) is highly effective in preventing HIV acquisition in women.

4. nature.com nature.com/articles/s41467-025-60752-y

Potential impact and cost-effectiveness of long-acting ... We evaluate the potential effectiveness and cost-effectiveness of introduction of a new combination of long-acting injectable drugs of lenacapavir + ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06970223

NCT06970223 | A Study to Investigate if Long Acting ... ... Long Acting Cabotegravir Intramuscular and Lenacapavir Subcutaneous Injections Over Time in Healthy Adults Without HIV. Conditions. HIV Infections. HIV ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10415942/

Safety and Efficacy of Long-Acting Injectable Agents for HIV-1 Cabotegravir is a novel integrase inhibitor with acceptable safety and tolerability when administered orally once daily [18]. The nonnucleoside reverse ...

7. natap.org natap.org/2025/EACS/GLOBAL_ViiVHealthcare_EACSandIDWeek_CurtainRaiser_FINAL_091025.pdf

Press Release acceptability and tolerability of cabotegravir long-acting (CAB LA) and lenacapavir (LEN) injections after a single dose.1 New effectiveness ...

8. academic.oup.com academic.oup.com/ofid/article/11/4/ofae125/7646382

Case Series of People With HIV on the Long-Acting ... Lenacapavir (LEN) is an LA capsid inhibitor given every 6 months, but has not been studied in combination with other LA agents.