Lenacapavir for HIV

Recruiting at 8 trial locations

Overseen By Gilead Clinical Study Information Center

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Gilead Sciences

Must be taking: Antiretrovirals

Disqualifiers: Tuberculosis, Hepatitis C, Hepatitis B, 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: 26 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests lenacapavir, a long-acting treatment for young people living with HIV-1. It aims to determine the safety and effectiveness of lenacapavir when combined with other HIV medicines. Participants will receive lenacapavir either as an injection or a pill. The trial seeks individuals whose current HIV treatment is no longer effective and who have limited options due to resistance or side effects. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not require you to stop your current medications. Participants must continue their existing antiretroviral regimen until the start of the study.

Is there any evidence suggesting that lenacapavir is likely to be safe for humans?

Research has shown that lenacapavir is generally safe and well-tolerated for people with HIV. Studies have found that both the pill and injection forms of lenacapavir are effective and have manageable side effects. Most participants in these studies did not experience serious side effects.

Lenacapavir was also tested in large trials for HIV prevention and proved to be very safe, with few participants encountering major issues. These findings suggest that lenacapavir is a promising treatment option with a strong safety record for people living with HIV. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HIV?

Lenacapavir is unique because it offers a new way to manage HIV with less frequent dosing. Unlike standard HIV treatments that often require daily pills, Lenacapavir uses a novel delivery method with subcutaneous injections every six months. This extended dosing schedule could make it easier for people to stick to their treatment plan, potentially improving outcomes. Researchers are excited about Lenacapavir because it targets the HIV capsid, a different mechanism of action compared to most existing therapies, which could provide a powerful new tool in the fight against HIV.

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

Research has shown that lenacapavir effectively treats HIV. In this trial, participants will receive lenacapavir alongside their optimized background regimen (OBR). When combined with other HIV treatments, lenacapavir has maintained the virus at very low levels in the body, achieving virological suppression. Taken only twice a year, lenacapavir offers a convenient option for many. Most patients have tolerated it well, experiencing no serious side effects. This treatment has shown promising results in controlling the virus over an extended period. ^{6 7 8 9 10}

Who Is on the Research Team?

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

This trial is for adolescents and children over 35 kg with HIV-1 who have been previously treated but are on a failing regimen. They must have an eGFR ≥ 60 mL/min/1.73 m^2, hemoglobin ≥ 8.5 g/dL, neutrophil count > 500 cells/mm^3, platelets ≥ 50,000/mm^3, and a plasma HIV-1 RNA level of at least 400 copies/mL.

Inclusion Criteria

My platelet count is at least 50,000 per mm3.

My white blood cell count is above 500.

My HIV viral load has been over 400 copies/mL for at least 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral LEN 600 mg on Days 1 and 2, and 2 doses of LEN 927 mg as subcutaneous injection on Day 1 and Week 26 along with their optimized background regimen

26 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants have the option to receive SC LEN every 6 months while continuing their OBR for at least another 2 SC LEN doses

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Lenacapavir

Trial Overview The study tests the safety and effectiveness of Lenacapavir (LEN), taken as an injection or pill in combination with other drugs for treating HIV-1 in treatment-experienced kids. It will also assess how LEN affects the body when used with optimized background regimen (OBR).

How Is the Trial Designed?

Group I: LEN Experimental Treatment 3 Interventions

Participants will receive oral LEN 600 mg on Days 1 and 2. Participants will also receive 2 doses of LEN 927 mg as subcutaneous (SC) injection on Day 1 and Week 26 along with their OBR per clinical practice. At the Week 52, participants will be given the option to receive SC LEN every 6 months while continuing their OBR for at least another 2 SC LEN doses in the extension phase.

Who Is Running the Clinical Trial?

Gilead Sciences

Lead 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

Published Research Related to This Trial

Lenacapavir (LEN) is a novel capsid inhibitor that offers a unique treatment option for heavily treatment-experienced (HTE) HIV-1 patients, demonstrating efficacy in achieving viral suppression and immune restoration when combined with other antiretrovirals.

Administered subcutaneously twice a year, lenacapavir provides a convenient dosing schedule, making it a well-tolerated and effective addition to existing HIV treatment regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenacapavir: A Novel Long-Acting Capsid Inhibitor for HIV. Tailor, MW., Chahine, EB., Koren, D., et al.[2023]

Lenacapavir is the first FDA-approved capsid inhibitor for treating multidrug-resistant HIV-1, specifically for heavily treatment-experienced adults whose current therapies are failing due to resistance or safety issues.

In a phase 3 clinical trial, lenacapavir significantly reduced viral load compared to placebo, and it is administered as a long-acting injection every 6 months, although 63% of participants experienced injection site reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenacapavir: A first-in-class capsid inhibitor for the treatment of highly treatment-resistant HIV. Prather, C., Lee, A., Yen, C.[2023]

Citations

1. gilead.com gilead.com/news/news-details/2024/full-efficacy-and-safety-results-for-gilead-investigational-twice-yearly-lenacapavir-for-hiv-prevention-presented-at-aids-2024

Full Efficacy and Safety Results for Gilead Investigational ... Additionally, compared to once-daily Truvada, lenacapavir reduced HIV incidence by 100%, a result that was statistically superior (IRR 0; 95% CI ...

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

Twice-Yearly Lenacapavir for HIV Prevention in Men and ... Twice-yearly subcutaneous lenacapavir has been shown to be efficacious for prevention of human immunodeficiency virus (HIV) infection in cisgender women.

3. who.int who.int/news/item/19-06-2025-fda-approval-of-injectable-lenacapavir-marks-progress-for-hiv-prevention

FDA approval of injectable lenacapavir marks progress for ... Administered just twice a year, lenacapavir offers sustained protection and adds to the growing range of HIV prevention options. WHO currently ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39206943/

Week 104 Results of a Phase 2/3 Trial Treatment with subcutaneous lenacapavir in combination with an OBR was well tolerated and resulted in a high rate of virological suppression over 104 weeks.

5. thelancet.com thelancet.com/journals/lanam/article/PIIS2667-193X(25)00156-5/fulltext

Lenacapavir: a potential game changer for HIV prevention ... In PURPOSE 2, lenacapavir had a 96% efficacy for PrEP compared to the background HIV incidence and was superior to F/TDF among men who have sex ...

6. askgileadmedical.com askgileadmedical.com/docs/sunlenca/sunlenca-safety-overview

For HCP's | Sunlenca® (lenacapavir) Safety Overview This document is in response to your request for information regarding the safety of Sunlenca® (lenacapavir [LEN]) in people with HIV-1 (PWH).

7. clinicalinfo.hiv.gov clinicalinfo.hiv.gov/en/guidelines/perinatal/safety-toxicity-arv-agents-capsid-inhibitors-lenacapavir-sunlenca

Appendix B: Lenacapavir - Safety and Toxicity in Pregnancy LEN is under evaluation for HIV pre-exposure prophylaxis (PrEP); LEN is not FDA approved for HIV prevention. Human Studies in Pregnancy. Pharmacokinetics. No ...

8. gilead.com gilead.com/news/news-details/2024/gilead-presents-additional-efficacy-safety-and-demographic-data-from-purpose-2-trial-at-5th-hiv-research-for-prevention-conference

October 7, 2024 Lenacapavir was highly effective at reducing infections among trial participants: 99.9% of participants did not acquire HIV in the lenacapavir ...

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

Injectable Lenacapavir for PrEP Shown to be highly effective at preventing HIV in two large Phase III clinical trials, PURPOSE 1 and PURPOSE 2. Early results from PURPOSE 1 ...

10. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)00405-2/fulltext

Pharmacokinetics and safety of once-yearly lenacapavir Both formulations were safe and well tolerated. These data show the potential for biomedical HIV prevention with a once-yearly dosing interval.