Combination Antiretroviral Therapy for HIV

Recruiting at 38 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: Immunosuppression, 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

83 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 3 4 5 7}

Research Team

Gilead Study Director

Principal Investigator

Gilead Sciences

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Randomized Phase: Lenacapavir (LEN) + Teropavimab Dose A + Zinlirvimab Dose B Experimental Treatment 4 Interventions

Participants will receive oral LEN 600mg, subcutaneous (SC) LEN 927 mg, teropavimab Dose A, and zinlirvimab Dose B on Day 1. Participants will self-administer oral LEN 600 mg on Day 2. The last treatment regimen will include SC LEN + teropavimab Dose A + zinlirvimab Dose B.

Group II: Randomized Phase: Antiretroviral Therapy (ART) Experimental Treatment 1 Intervention

Participants will continue their baseline oral ART through Week 52.

Group III: Extension Phase: LEN + Teropavimab Dose A + Zinlirvimab Dose B Experimental Treatment 3 Interventions

At Week 52, participants who receive the study drug of LEN, teropavimab, zinlirvimab, and complete study through Week 52 with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL will be given the option to participate in the study extension phase, where they will continue to receive their randomized study drugs treatment regimen until after completion of the primary analysis (unless modified based on the data monitoring committee (DMC) analysis), up to approximately 5 years.

Group IV: Extension Phase: ART Experimental Treatment 4 Interventions

Participants who complete study through Week 52 with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound (VR) throughout the randomized phase of the study will be given the option to participate in the extension phase and receive the study drugs of LEN, teropavimab, and zinlirvimab at the dose specified for randomized phase until after completion of the primary analysis (unless modified based on the data monitoring committee (DMC) analysis), up to approximately 5 years. Treatment with study drug will begin at Week 52 and at that time the baseline oral ART will be discontinued.

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. England pubmed.ncbi.nlm.nih.gov

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. 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]

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

Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. [2022]