Lenacapavir Long-Acting for HIV Prevention

(INCLUSION Trial)

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Duke University

Must be taking: Lenacapavir

Must not be taking: Significant interaction drugs

Disqualifiers: HIV, Female sex, Severe renal/hepatic, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new long-acting injectable medication called lenacapavir to prevent HIV. The research examines its effectiveness for Latine gay and bisexual men and transgender women, particularly in maintaining adherence over time. Suitable participants are those assigned male at birth, who identify as Hispanic or Latine, are HIV-negative, and are interested in using PrEP (a preventive HIV treatment). As a Phase 4 trial, lenacapavir has already received FDA approval and proven effective, and this research aims to understand its benefits for a broader range of patients.

Will I have to stop taking my current medications?

If you are currently taking oral PrEP, you must switch to lenacapavir for the study. Also, if you take any medication that interacts significantly with lenacapavir, you cannot participate.

What is the safety track record for lenacapavir?

Research has shown that lenacapavir is a safe option for preventing HIV. In a large study, only a small number of participants (1.2%) experienced mild side effects, mostly at the injection site. Another study found no major safety issues. The FDA has approved lenacapavir for HIV prevention, indicating it meets strict safety standards for public use. Overall, lenacapavir appears well-tolerated, making it a promising choice for those seeking long-lasting HIV prevention. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Lenacapavir is unique because it's a long-acting injectable option for HIV prevention, which sets it apart from the daily oral pills like Truvada or Descovy that are currently standard. Researchers are excited about lenacapavir because it offers a new delivery method, requiring less frequent dosing, which could significantly improve adherence for people who struggle with taking daily medication. This injectable approach is especially promising for Latine gay and bisexual men and transgender women, potentially providing a more convenient and private way to manage HIV prevention.

What evidence suggests that lenacapavir might be an effective treatment for HIV prevention?

Research has shown that lenacapavir, included in this trial's long-acting injectable PrEP program, is highly effective at preventing HIV. Studies have found it to be nearly 100% successful in stopping HIV infections. Compared to daily Truvada®, lenacapavir performs better at preventing HIV. Clinical trials confirmed its safety and effectiveness when used twice a year as a long-lasting injection for HIV prevention. This makes lenacapavir a promising choice for those seeking reliable HIV prevention. ^{1 6 7 8 9}

Who Is on the Research Team?

Tonia Poteat, PhD

Principal Investigator

Duke University Medical Center - Professor in the School of Nursing

Are You a Good Fit for This Trial?

This trial is for Latine transgender women and gay/bisexual men in the South who are interested in a new HIV prevention method. Participants should be willing to try a long-acting injectable form of PrEP (lenacapavir). Specific eligibility criteria details were not provided.

Inclusion Criteria

Identify as Hispanic and/or Latine

I can give informed consent in English or Spanish.

I am 18 years old or older.

Exclusion Criteria

Individuals living with HIV

I was assigned female at birth.

I am taking PrEP from another source and don't want to switch.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive long-acting injectable PrEP (lenacapavir) as part of a community-delivered program

up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lenacapavir

Trial Overview The study is testing lenacapavir, a long-acting injectable drug for HIV prevention. It aims to see if this culturally-tailored program increases the use and continuation of PrEP among Latine GBM and TGW compared to past results from the Duke PrEP Clinic.

How Is the Trial Designed?

Group I: Long-acting Injectable PrEP (lenacapavir) program Experimental Treatment 1 Intervention

Community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW)

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

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

1. gilead.com gilead.com/news/news-details/2024/gileads-twice-yearly-lenacapavir-demonstrated-100-efficacy-and-superiority-to-daily-truvada-for-hiv-prevention

Gileads Twice Yearly Lenacapavir Demonstrated 100 ... Gilead's Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention.

2. prepwatch.org prepwatch.org/products/lenacapavir-for-prep/

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-prevention

NIH 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 ...

4. nejm.org nejm.org/doi/10.1056/NEJMoa2407001

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) ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2667193X25001565

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 ...

6. gilead.com gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection

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.

7. cdc.gov cdc.gov/mmwr/volumes/74/wr/mm7435a1.htm

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 ...

8. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2411858

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 ...

9. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK616670/

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 ...