Cabotegravir + Lenacapavir for Injection Tolerability
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.12345Why 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.13678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CAB LA injection at Day 1 and LEN LA injection at Day 15, or vice versa
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Participants receive the LEN LA injections at Day 1 followed by the CAB LA injection at Day 15.
Participants receive the CAB LA injection at Day 1 followed by the LEN LA injections at Day 15.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ViiV Healthcare
Lead Sponsor
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 ...
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 ...
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.
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 + ...
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 ...
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 ...
Press Release
acceptability and tolerability of cabotegravir long-acting (CAB LA) and lenacapavir (LEN) injections after a single dose.1 New effectiveness ...
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.
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