Lenacapavir for PrEP
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of lenacapavir, an injectable medication, as a long-term option to prevent HIV. Researchers aim to determine if allowing participants to choose their follow-up care location—at home, in the community, or in a clinic—improves adherence compared to clinic-only visits. They also assess the safety, acceptability, and costs for participants. This trial suits HIV-negative individuals in Massachusetts who qualify for HIV prevention treatment and are willing to try the injectable medication and follow the study's procedures. As an unphased trial, it offers a unique opportunity to contribute to innovative HIV prevention strategies.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have a significant drug interaction with lenacapavir, you may not be eligible to participate.
Is there any evidence suggesting that lenacapavir is likely to be safe for humans?
Research has shown that lenacapavir, an injectable treatment to prevent HIV, is generally safe. Earlier studies found that both adults and teenagers using lenacapavir for PrEP (pre-exposure prophylaxis) experienced similar safety outcomes, indicating that lenacapavir is usually well-tolerated across different age groups.
Only a few safety concerns exist, mainly mild reactions at the injection site, which are common with shots. Overall, lenacapavir has been used effectively to prevent HIV without major safety issues. This information supports its safety for those considering participation in a clinical trial for lenacapavir.12345Why are researchers excited about this trial?
Lenacapavir is unique because it offers a new approach to HIV prevention. Unlike current PrEP options that typically require daily oral medication, Lenacapavir is designed to be administered as a long-acting injectable, potentially every six months. This could significantly improve adherence and convenience for users. Researchers are excited about Lenacapavir because it targets a different part of the HIV life cycle, potentially offering a more robust barrier against infection.
What evidence suggests that this trial's treatments could be effective for PrEP?
Research has shown that lenacapavir is a strong option for preventing HIV. In one study, lenacapavir prevented HIV in 100% of women and 96% of mostly male participants. Another study found that only 0.1% of people using lenacapavir contracted HIV, a rate much lower than expected without it. These impressive results suggest lenacapavir can be a highly effective choice for HIV prevention. Participants in this trial will join either the PrEP Choice arm, where they can choose their follow-up location, or the PrEP Clinic arm, where follow-up occurs at the clinic.2678
Who Is on the Research Team?
Ruanne V Barnabas, MBChB, PhD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
The PrEP4U trial is for HIV-negative individuals in Massachusetts who meet CDC guidelines for HIV PrEP, can consent to participate, are willing to receive injectable lenacapavir and follow study procedures, and will be available for a 6-month follow-up.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Same-day Initiation
Participants begin lenacapavir PrEP with rapid HIV testing and choose follow-up location
Follow-up
Participants receive follow-up care at chosen location (home, community, or clinic) to improve PrEP persistence
Monitoring and Evaluation
Participants are monitored for safety, acceptability, and persistence of PrEP
What Are the Treatments Tested in This Trial?
Interventions
- Lenacapavir
Trial Overview
This trial tests the effectiveness of same-day lenacapavir initiation with a choice of follow-up location (home, community, or clinic) on maintaining use of PrEP. It aims to inform best practices for long-acting injectable PrEP implementation.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The PrEP Choice arm allows participants to choose where they receive their follow up
The PrEP Clinic arm will be randomized to receive follow up at the clinic
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Brigham and Women's Hospital
Collaborator
Citations
Clinical Recommendation for the Use of Injectable ...
This report describes a clinical recommendation to use injectable lenacapavir as an HIV preexposure prophylaxis.
Clinical Recommendation for the Use of Injectable ...
The two trials reported LEN efficacy at reducing HIV infection as 100% among females and 96% among a primarily male trial population, compared ...
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) ...
Gilead Presents Full PURPOSE 2 Data Results for Twice ...
Lenacapavir was highly effective at reducing HIV infections among trial participants: 99.9% of participants did not acquire HIV in the ...
Lenacapavir for PrEP | Dosing & Administration ...
In the 59 adolescents who received LEN for PrEP, the safety data were comparable to the safety data reported in adults receiving LEN for PrEP. Adolescents ...
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 ...
Injectable Lenacapavir for PrEP
In the first year since efficacy results were reported, LEN for PrEP has achieved critical milestones in record time compared to oral PrEP, DVR, and CAB; ...
NCT07047716 | Study of Lenacapavir as a Once-Yearly ...
The primary objective of this study is to evaluate the pharmacokinetics (PK) and the safety and tolerability of intramuscular (IM) every 12 months (Q12M) LEN ...
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