Lenacapavir for HIV

Recruiting at 6 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

Trial Summary

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.

What data supports the effectiveness of the drug Lenacapavir for treating HIV?

Lenacapavir has been shown to be effective in treating HIV, especially in people with multidrug-resistant HIV who have limited treatment options. Clinical trials demonstrated its ability to work well when combined with other HIV medications, and it was approved by the U.S. Food and Drug Administration for this purpose. ^{1 2 3 4 5}

Is lenacapavir safe for humans?

Lenacapavir has been tested in clinical trials for people with multidrug-resistant HIV and was generally well tolerated. The most common side effects were mild to moderate reactions at the injection site, stomach issues, and headaches. ^{2 3 6 7 8}

How is the drug Lenacapavir different from other HIV treatments?

Lenacapavir is unique because it is a first-in-class capsid inhibitor, which means it targets a different part of the HIV virus than other drugs. It can be given as an injection every six months, reducing the need for daily pills, which is especially helpful for people with multidrug-resistant HIV. ^{1 2 6 8 9}

What is the purpose of this trial?

The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1. The study will also see how easy it is for participants to take LEN as injection or an oral pill. The primary objectives are to evaluate the pharmacokinetics and safety of LEN in combination with optimized background regimen (OBR) in TE pediatric participants with HIV-1.

Research Team

Gilead Study Director

Principal Investigator

Gilead Sciences

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Lenacapavir administered every 26 weeks or daily in combination with oral daily antiretroviral therapy for initial treatment of HIV: a randomised, open-label, active-controlled, phase 2 trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Lenacapavir: A Novel Long-Acting Capsid Inhibitor for HIV. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Lenacapavir: a twice-yearly treatment for adults with multidrug-resistant HIV infection and limited treatment options. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Lenacapavir: a first-in-class HIV-1 capsid inhibitor. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Lenacapavir and the novel HIV-1 capsid inhibitors: an emerging therapy in the management of multidrug-resistant HIV-1 virus. [2023]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the novel capsid inhibitor lenacapavir to treat multidrug-resistant HIV: week 52 results of a phase 2/3 trial. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Lenacapavir: A novel injectable HIV-1 capsid inhibitor. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Antiviral Activity of Lenacapavir Against HIV-2 Isolates and Drug-resistant HIV-2 Mutants. [2023]