Lenacapavir + Teropavimab + Zinlirvimab for HIV Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new long-acting injection treatment for people with HIV-1. Researchers aim to determine if the combination of lenacapavir (an experimental treatment), teropavimab, and zinlirvimab is as effective as the current standard injections, cabotegravir and rilpivirine, in keeping the virus suppressed. The trial targets individuals whose HIV is well-controlled on daily oral medication. Participants must have maintained an undetectable HIV-1 viral load (very low virus levels in the blood) for at least six months and have no history of certain drug resistances. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies found that the combination of lenacapavir, teropavimab, and zinlirvimab was well tolerated, indicating general safety for people. Research has shown no serious side effects were reported. Over a year, patients managed this treatment well.
This treatment aims to control HIV with fewer doses. As a long-acting injection, it may require fewer shots compared to daily pills. This combination could be a promising option for managing HIV.
Overall, the safety data is positive, with participants maintaining viral control and experiencing only minor side effects. This could lead to a safer and more convenient treatment option in the future.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination treatment of Lenacapavir, Teropavimab, and Zinlirvimab for HIV because it introduces a unique mix of mechanisms and delivery methods. Unlike the standard oral antiretroviral therapies, this treatment involves both subcutaneous and intravenous administration, potentially offering longer-lasting effects with dosing every 26 weeks. Lenacapavir targets a different part of the HIV lifecycle compared to most traditional therapies, which could help overcome resistance issues with current drugs. Meanwhile, the combination of monoclonal antibodies Teropavimab and Zinlirvimab adds an innovative layer of defense by directly neutralizing the virus. This multi-faceted approach could lead to more effective and manageable HIV treatment options.
What evidence suggests that this trial's treatments could be effective for HIV?
Research has shown that the combination of the drugs lenacapavir, teropavimab, and zinlirvimab, which participants in Treatment Group 1 of this trial will receive, shows promise for treating HIV. In earlier studies, this combination matched the effectiveness of daily HIV pills for up to 26 weeks. Specifically, more than 80% of participants maintained viral control during a 104-week follow-up. Participants generally tolerated the treatment well. These results suggest that this long-lasting injectable treatment could be an effective option for people with HIV-1.12356
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 adults with HIV-1 whose virus has been well controlled (undetectable levels) on daily oral HIV medication for at least 6 months. Participants must have no recent treatment failures and meet specific lab criteria showing their virus can be treated by the study drugs.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either LEN, TAB, and ZAB or CAB and RPV injections. LEN, TAB, and ZAB are administered every 26 weeks, while CAB and RPV are administered every 8 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Eligible participants may continue LEN + TAB + ZAB in the extension phase until completion or discontinuation.
What Are the Treatments Tested in This Trial?
Interventions
- Cabotegravir
- Lenacapavir
- Rilpivirine
- Teropavimab
- Zinlirvimab
Trial Overview
The study compares two long-acting injectable treatments: one group gets lenacapavir, teropavimab, and zinlirvimab; the other gets cabotegravir and rilpivirine. Injections are given every 8 weeks to see which keeps HIV suppressed better after switching from daily pills.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive oral LEN 600 mg, subcutaneous (SC) LEN 927 mg, and intravenously (IV) infusions of TAB and ZAB on Day 1. Participants will self-administer oral LEN 600 mg on Day 2. Every 26 weeks, participants will receive SC LEN and IV infusions of TAB and ZAB up to Week 92. After Week 92, eligible participants will have an option to continue LEN + TAB + ZAB in the extension phase, until completion of the extension phase, permanently discontinuing the extension phase or the extension is discontinued at the sponsor's sole discretion, whichever occurs first.
Participants will discontinue their baseline oral antiretroviral therapy (ART) and will receive intramuscular (IM) CAB 600 mg + RPV 900 mg on Day 1, Week 4 and then every 8 weeks for up to 92 weeks. After Week 92, eligible participants will have an option to continue LEN + TAB + ZAB in the extension phase, until completion of the extension phase, permanently discounting the extension phase or the extension is discontinued at the sponsor's sole discretion, whichever occurs first.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gilead Sciences
Lead Sponsor
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
Citations
Efficacy and safety of lenacapavir, teropavimab, and ...
A single administration of lenacapavir, teropavimab, and zinlirvimab in the study population demonstrated similar efficacy to daily oral ART through to week 26.
2.
askgileadmedical.com
askgileadmedical.com/docs/conference/Ogbuagu_EACS%202025%20Presentation_LTZ%20Ph2%20W52%20Efficacy_Safety_16Oct25_Final@pdfPhase 2 Week 52 Results
HIV Dependent Quality of Life Questionnaire scores in the LEN, TAB, and ZAB group improved from baseline to Week 52. ART, antiretroviral therapy ...
EACS 2025: Novel HIV combo therapy of lenacapavir and ...
LEN, when administered with teropavimab zinlirvimab (ZAB, Gilead), produced only a slightly lower average increase in CD4+ counts than a stable
NCT05729568 | A Study of Teropavimab and Zinlirvimab in ...
Efficacy and safety of lenacapavir, teropavimab, and zinlirvimab: week-26 primary outcome results from a multicentre, open-label, randomised, active-controlled ...
Efficacy and safety of lenacapavir, teropavimab ...
During 104 weeks of follow-up, viral suppression was maintained in 82% of participants still on treatment and with HIV-1 RNA measurements ...
Safety of teropavimab and zinlirvimab with lenacapavir ...
Lenacapavir with teropavimab and zinlirvimab 10 mg/kg or 30 mg/kg was generally well tolerated with no serious adverse events. HIV-1 suppression for at least 26 ...
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