Study of Lenacapavir, Teropavimab, and Zinlirvimab for HIV-1
This study is for adults with HIV-1 whose virus is well controlled on their current daily oral medication. It aims to see how effective a new long-acting injectable treatment, made up of lenacapavir, teropavimab, and zinlirvimab, is compared to another injectable treatment, cabotegravir and rilpivirine. Both treatments are given every 8 weeks. The main goal is to see if your HIV-1 virus remains suppressed (meaning the amount of virus in your blood, called HIV-1 RNA, stays below 50 copies/mL) after 52 weeks (1 year) of treatment. To join, you must be at least 18 years old and have specific HIV-1 test results showing your virus is susceptible to certain study medications.
- Study design
- This is an interventional study planning to enroll 590 participants. It compares two different injectable HIV-1 treatments.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at Week 52, indicating participants will be followed for at least one year.
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NCT07682961
Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
Recruiting
PHASE3Ages 18+InterventionalTreatmentGilead Sciences
~590 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:LenacapavirLenacapavir TabletTeropavimabZinlirvimabCabotegravirRilpivirine
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants With HIV-1 ribonucleic acid (RNA) ≥ 50 Copies/mL at Week 52 as Defined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm.
Measured over Week 52
Conditions
Where it's being run
3 sites across 2 statesFlorida2
Michigan1
Study leadership
- Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria:
At least 1 documented HIV-1 RNA level measured between 6 months and 12 months (+2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be \< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). A single virologic elevation of ≥ 50 copies/mL and \< 400 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable if the subsequent plasma HIV-1 RNA level is \< 50 copies/mL.
A plasma HIV-1 RNA test \< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) within the last 6 months prior to screening.
On a stable oral ARV therapy (ART) for ≥ 6 months prior to screening.
Exclusion
History of an opportunistic infection or illness indicative of Stage 3 HIV disease.
History of treatment failure.
Known or suspected resistance to either CAB or RPV.
Individuals with a dermatologic condition or implanted prothesis overlying the gluteal injection site for CAB + RPV.
Known hypersensitivity to the study intervention, its metabolites, or formulation excipients.
Active, serious infections (other than HIV-1) requiring therapy \< 30 days prior to randomization.
Active tuberculosis infection.
Acute hepatitis of any cause \< 30 days before randomization.
History of, or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or severe hepatic impairment (Child-Pugh Class C).
Active malignancy requiring acute systemic therapy.
Have poor venous access that would limit phlebotomy or intravenous (IV) infusion of study drugs.
Prior use of, or exposure to, LEN or a broadly neutralizing antibody (bNAb) for HIV-1.
Prior use of, or exposure to, long-acting (LA) injectable CAB or LA injectable RPV.
Prior use of, or exposure to, ibalizumab, fostemsavir, or maraviroc.
Baseline regimen consisting of monotherapy with any single antiretroviral (ARV).
Treatment with immunosuppressant therapies (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) within 4 weeks of screening (with the exception of a single short course of corticosteroids lasting ≤ 7 days) or have a comorbid condition with an anticipated need ongoing immunosuppressive treatment during the study.
Hepatitis C virus (HCV) antibody positive and HCV RNA detectable.
Chronic hepatitis B virus (HBV) infection, as determined by either:
Severe renal impairment-estimated glomerular filtration rate \< 30 mL/min according to the Cockcroft-Gault formula.
Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant, as determined by the investigator.
Any of the following laboratory values at screening:
What this trial measures
- Proportion of Participants With HIV-1 ribonucleic acid (RNA) ≥ 50 Copies/mL at Week 52 as Defined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm.Week 52