Lenacapavir for HIV

Overseen By Chuen-Yen C Lau, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must be taking: ART

Must not be taking: Anticoagulants, Anticonvulsants, Antiretrovirals, others

Disqualifiers: AIDS, Hepatitis B/C, Pregnancy, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 12

Duration: 48 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications, including specific antiarrhythmics, anticoagulants, anticonvulsants, antiretroviral agents, antimycobacterials, systemic corticosteroids, ergot derivatives, herbal products like St. John's wort, certain cholesterol medications, some narcotic analgesics, opioid dependence treatments, opioid antagonists, PDE-5 inhibitors, and certain sedatives. If you are on any of these, you may need to stop them to participate in the trial.

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

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. ^{1 5 6 7 8}

What makes the drug Lenacapavir unique for treating HIV?

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 4 6 8 9}

What is the purpose of this trial?

Pending...

Research Team

Chuen-Yen C Lau, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria

This trial is for adults aged 18-75 with HIV who are in good health, have been on antiretroviral therapy (ART) for over 3 years with a suppressed viral load, and have a CD4+ T cell count above 200. They must not be pregnant or breastfeeding and agree to use contraception. Exclusions include recent illness, drug abuse, certain medication use, other infections like hepatitis B/C, and inability to undergo leukapheresis.

Inclusion Criteria

Able to provide informed consent

In generally good health with an identified primary health care provider for medical management of HIV infection and willing to maintain a relationship with a primary health care provider while participating in the study

Confirmed HIV-1 infection

Exclusion Criteria

Laboratory abnormalities in specified parameters

I have not had an AIDS-defining illness in the last 3 years.

Pregnancy or lactation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lenacapavir intensification or continue ART alone

48 weeks

Injections at weeks 0, 24, and 48; oral doses on days 0 and 1

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

Visits at weeks 12, 24, 48, 72, and 96

Treatment Details

Interventions

• Lenacapavir

Trial Overview The trial is testing Lenacapavir's ability to disrupt HIV reservoirs in people whose virus is already under control with ART. Participants will receive Lenacapavir intensification alongside their current treatment regimen to assess its impact on the size of the HIV reservoir.

Participant Groups

Group I: Interventional Experimental Treatment 1 Intervention

Participants will receive lenacapavir at 927 mg by subcutaneous injection (2x1.5 mL injections) on day 0 and 600 mg orally (2x300 mg tablets) on days 0 and 1, followed by 927 mg by subcutaneous injection (2x1.5 mL injections) at weeks 24 and 48.

Group II: Standard of Care Active Control 1 Intervention

Participants who are not randomized to lenacapavir will remain on their current ART regimens.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

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

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

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

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

3. 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]

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

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