Lenacapavir for HIV Prevention
(L4PinPharm Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how Lenacapavir can help prevent HIV when managed by pharmacists in a community setting. Researchers aim to determine the effectiveness of pharmacist-led visits either twice a year or every three months. The trial will also assess how these visit schedules impact sexually transmitted infection (STI) rates. It suits individuals who are HIV-negative and not taking other medications that interfere with Lenacapavir. Participants should be comfortable with regular pharmacy visits and providing feedback about their experience. As a Phase 4 trial, Lenacapavir has already received FDA approval and proven effective, and this research seeks to understand how it benefits more patients.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot take drugs that significantly decrease lenacapavir concentrations.
What is the safety track record for Lenacapavir?
Research has shown that lenacapavir is safe for people. In studies, it proved very effective at preventing HIV. Importantly, trials found no major safety issues. Among more than 2,000 people who took lenacapavir, only about 1.2% experienced side effects, mostly mild reactions at the injection site. The FDA has approved lenacapavir for preventing HIV, indicating that the treatment is generally safe and well-tolerated.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about lenacapavir for HIV prevention because it offers a new approach to pre-exposure prophylaxis (PrEP). Unlike the standard of care options, which typically involve daily oral pills, lenacapavir is a long-acting injectable that could potentially be administered less frequently, such as every six months. This reduced dosing schedule could greatly improve adherence and convenience for users. Additionally, lenacapavir targets a unique site on the HIV capsid, potentially offering an effective alternative for those who may not respond well to current PrEP methods.
What evidence suggests that lenacapavir might be an effective treatment for HIV prevention?
Research has shown that lenacapavir is highly effective in preventing HIV. Studies have found it to be almost 100% effective, surpassing the daily pill Truvada®. Large trials demonstrated that lenacapavir is safe and effective as a long-lasting option for HIV prevention. This trial will explore lenacapavir's use in different settings, including a pharmacist-managed program and varying visit frequencies. The strong evidence makes lenacapavir a promising choice for those seeking to prevent HIV.16789
Are You a Good Fit for This Trial?
This trial is for adults over 18 who weigh at least 35kg and are HIV-negative. They must be willing to consent to study procedures. People with unknown or positive HIV status, those taking drugs that affect Lenacapavir levels, or not suitable for management under the CDTA can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initiation
Participants start or switch to commercially available L4P, with administration on Day 1 and Day 2 (oral loading dose only)
Treatment
Participants receive L4P administered every six months, managed by a pharmacist provider
Follow-up
Participants are monitored for safety and effectiveness after treatment, with surveys conducted at 4-6 weeks and study end
Open-label extension (optional)
Participants may opt to continue commercially available L4P after the study
What Are the Treatments Tested in This Trial?
Interventions
- Lenacapavir
Trial Overview
The study tests how well a pharmacist-managed delivery of Lenacapavir works in a community pharmacy setting for HIV prevention (PrEP). It also looks at the effects of having PrEP visits twice yearly versus quarterly on STI rates.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
The 75 subjects who provided informed consent will be retrospectively case control matched to a cohort of people for age, gender identity, insurance status, postal code, predictors of STI risk, number of partners, genders of partners, condomless sex, receptive anal sex. Adjustments will be made to matching ratio if all matches are not found.
prospective observational study enrolling 75 subjects into the cohort to report on the feasibility and acceptability of a pharmacist-managed L4P in a community pharmacy setting. This will be done as a longitudinal, observational, mixed methods study to report on experiences of operating this service for 1 year.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kelley-Ross & Associates, Inc.
Lead Sponsor
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
Citations
Gileads Twice Yearly Lenacapavir Demonstrated 100 ...
Gilead's Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention.
Injectable Lenacapavir for PrEP
Effectiveness. Shown to be highly effective at preventing HIV in two large Phase III clinical trials, PURPOSE 1 and PURPOSE 2. Early results ...
3.
niaid.nih.gov
niaid.nih.gov/news-events/nih-statement-preliminary-efficacy-results-twice-yearly-lenacapavir-hiv-preventionNIH Statement on Preliminary Efficacy Results of Twice-Yearly ...
The injectable antiretroviral drug lenacapavir was safe and 100% effective as long-acting HIV pre-exposure prophylaxis (PrEP) among cisgender women in a Phase ...
Twice-Yearly Lenacapavir or Daily F/TAF for HIV ...
HIV incidence with lenacapavir was significantly lower than background HIV incidence (incidence rate ratio, 0.00; 95% CI, 0.00 to 0.04; P<0.001) ...
Lenacapavir: a potential game changer for HIV prevention ...
Lenacapavir, a first in class long-acting capsid inhibitor has near 100% efficacy in preventing HIV. As such, it has the potential to curb the rising HIV ...
Yeztugo® (Lenacapavir) Is Now the First and Only FDA ...
Yeztugo® (Lenacapavir) Is Now the First and Only FDA Approved HIV Prevention Option Offering 6 Months of Protection.
Clinical Recommendation for the Use of Injectable ...
In June 2025, FDA approved injectable lenacapavir (LEN) administered every 6 months as HIV PrEP, based on results from two randomized controlled ...
Twice-Yearly Lenacapavir for HIV Prevention in Men and ...
No safety concerns were identified. A total of 26 of 2183 participants (1.2%) in the lenacapavir group and 3 of 1088 (0.3%) in the F/TDF ...
Safety and efficacy of long-acting injectable lenacapavir as ...
Conclusion: LEN is an effective means of HIV prevention and appears to have few safety risks beyond injection site reactions. LEN may lead to an increased risk ...
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