83 Participants Needed

Combination Antiretroviral Therapy for HIV

Recruiting at 38 trial locations
GC
Overseen ByGilead Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Gilead Sciences
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination treatment for adults with HIV-1 who are already keeping the virus under control. The treatment uses special proteins to block the virus and a new medication to stop it from making more copies. Researchers want to see if this new approach works better than current treatments.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications, but it evaluates switching from your current antiretroviral therapy to a new regimen. It's best to discuss with the trial coordinators to understand if you need to stop or adjust your current medications.

Is the combination antiretroviral therapy including Lenacapavir safe for humans?

Lenacapavir has been shown to be safe and well-tolerated in clinical trials for people with multidrug-resistant HIV, with studies demonstrating its safety when used in combination with other antiretroviral agents.12345

How is 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, and is especially useful for people with HIV who have limited treatment options due to resistance to other medications.13467

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

Research shows that Lenacapavir, a new type of HIV drug, is effective for people with HIV who have limited treatment options due to resistance to other drugs. It works by targeting a part of the virus called the capsid, and it can be given as an injection every six months, which helps people stick to their treatment plan.12347

Who Is on the Research Team?

GS

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

This trial is for adults with HIV-1 who've had a stable viral load under 50 copies/mL for at least a year, no significant resistance to their current ART regimen, and CD4+ T-cell count over 200 cells/μL. They shouldn't have hepatitis B or C infections, require ongoing immunosuppression, or have had Stage 3 HIV illnesses.

Inclusion Criteria

My virus is sensitive to teropavimab and zinlirvimab based on recent tests.
I changed my HIV medication more than 28 days ago, not due to treatment failure.
I have been on a stable HIV medication regimen of up to 2 drug classes for over a year.
See 4 more

Exclusion Criteria

I currently have hepatitis B.
Evidence of hepatitis C virus (HCV) infection (prior infection cleared spontaneously or with treatment is acceptable)
I am on continuous medication to suppress my immune system due to another health condition.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomized Treatment

Participants receive either the combination of LEN, teropavimab, and zinlirvimab or continue their baseline oral ART

52 weeks
Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension Phase

Participants with HIV-1 RNA < 50 copies/mL at Week 52 can opt into an extension phase to continue receiving the study drugs

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Lenacapavir Injection
  • Lenacapavir Tablet
  • Teropavimab
  • Zinlirvimab
Trial Overview The study tests the effectiveness of switching from standard oral ART to a new regimen combining lenacapavir (LEN) with two antibodies, teropavimab and zinlirvimab. It measures if participants maintain low HIV RNA levels (<50 copies/mL) after this switch.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Randomized Phase: Lenacapavir (LEN) + Teropavimab Dose A + Zinlirvimab Dose BExperimental Treatment4 Interventions
Group II: Randomized Phase: Antiretroviral Therapy (ART)Experimental Treatment1 Intervention
Group III: Extension Phase: LEN + Teropavimab Dose A + Zinlirvimab Dose BExperimental Treatment3 Interventions
Group IV: Extension Phase: ARTExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

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

Citations

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]
Lenacapavir: A Novel Long-Acting Capsid Inhibitor for HIV. [2023]
Lenacapavir: a twice-yearly treatment for adults with multidrug-resistant HIV infection and limited treatment options. [2023]
Lenacapavir: A first-in-class capsid inhibitor for the treatment of highly treatment-resistant HIV. [2023]
Lenacapavir: A novel injectable HIV-1 capsid inhibitor. [2023]
Efficacy and safety of the novel capsid inhibitor lenacapavir to treat multidrug-resistant HIV: week 52 results of a phase 2/3 trial. [2023]
Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. [2022]
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