HIV-1-infectionPhase 3NCT07683000
Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens
A Phase 3 study testing Lenacapavir, Lenacapavir Tablet and Teropavimab in people with HIV-1-infection, run by Gilead Sciences at 2 sites in United States.
Trial summary
The goal of this clinical study is to compare how effective a long-acting treatment of injectable combination of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) is versus continuing a daily oral HIV treatment in adults with HIV-1 whose virus is already well controlled, after 1 year (52 weeks) of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Lenacapavir, Lenacapavir Tablet and Teropavimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jul 2026to Mar 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria:
- 1) Proviral phenotypic susceptibility to both TAB and ZAB by the investigational protocol-defined assay at screening.
- Plasma HIV-1 RNA levels < 50 copies/mL at screening.
- 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.
- If > 1 plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all 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).
- On a stable oral antiretroviral (ARV) therapy (ART) for ≥ 6 months prior to screening.
- A change in ART regimen ≥ 3 months prior to the screening visit for reasons other than virologic failure (eg, tolerability, simplification, drug-drug interaction profile) is allowed; individuals with a change in ART regimen ≥ 3 months prior to screening must have been on the regimen for ≥ 3 months prior to screening, and all HIV-1 RNA measurements in that period must be < 50 copies/mL. There are no permitted changes to ART regimens between screening and Day 1.
Who cannot join
- History of an opportunistic infection or illness indicative of Stage 3 HIV disease.
- 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).
Show all 27Show fewer
- 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 cabotegravir (CAB) or LA injectable rilpivirine (RPV).
- Prior use of, or exposure to, ibalizumab, fostemsavir, or maraviroc.
- Current use of, or exposure to, nevirapine or zidovudine.
- Baseline regimen consisting of monotherapy with any single 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:
- Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.
- Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.
- Note: Individuals found to be susceptible to HBV infection (eg, negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive an HBV vaccination. Those who remain non-immune will receive regular testing for HBV.
- 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:
- Alanine aminotransferase > 5 × upper limit of normal (ULN).
- Direct bilirubin > 1.5 × ULN
- Platelets < 50,000/mm^3.
- Hemoglobin < 8.0 g/dL.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
United States2 sites, 2 recruiting
- Recruiting
Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, 22003
- Recruiting
Be Well Medical Center
Berkeley, Michigan, 48072
About this study
Official title: A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to a Regimen of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir Twice-Yearly in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens
The goal of this clinical study is to compare how effective a long-acting treatment of injectable combination of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) is versus continuing a daily oral HIV treatment in adults with HIV-1 whose virus is already well controlled, after 1 year (52 weeks) of treatment.
The primary objective of this study is to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus continuing an oral stable baseline regimen (SBR) in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.
- Conditions
- HIV-1-infection
- Being tested
- Lenacapavir, Lenacapavir Tablet, Teropavimab, Zinlirvimab, SBR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenacapavirDrug
Also called LEN
Administered subcutaneously
Lenacapavir TabletDrug
Also called TAB, GS-5423
Administered orally
TeropavimabDrug
Also called TAB, GS-5423
Administered intravenously (IV)
ZinlirvimabDrug
Also called GS-2872
Administered IV
SBRDrug
SBRs administered orally. SBRs include medicines like bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) or dolutegravir (DTG)+ tenofovir alafenamide (TAF)+ emtricitabine (FTC).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1: Lenacapavir(LEN)+ Teropavimab(TAB)+ Zinlirvimab (ZAB) | Experimental | 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 study 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. Receives: Drug: Lenacapavir; Drug: Lenacapavir Tablet; Drug: Teropavimab; Drug: Zinlirvimab |
| Treatment Group 2: Stable Baseline Regimen (SBR) | Experimental | Participants will continue their SBR through at least Week 92. Oral SBRs will be taken per local prescribing information.
After Week 92, eligible participants will have an option to switch to LEN + TAB + ZAB in the study 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. Receives: Drug: SBR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Defined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm.
Measured: Week 52
Secondary outcomes (12)
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 92 as Defined by the US FDA Snapshot Algorithm.
Measured: Week 92
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm.
Measured: Week 52
Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 92 as Determined by the US FDA Snapshot Algorithm.
Measured: Week 92
Changes from Baseline in Clusters of Differentiation 4 (CD4)+ T-cell Counts at Week 52
Measured: Baseline, Week 52
Changes from Baseline in CD4+ T-cell Counts at Week 92
Measured: Baseline, Week 92
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Measured: First dose up to 92 weeks
Percentage of Participants Prematurely Discontinuing Their Study Treatment due to an AE
Measured: First dose up to 92 weeks
Trough Concentrations for LEN, TAB, and ZAB at Week 26
Measured: Week 26
Trough Concentrations for LEN, TAB, and ZAB at Week 52
Measured: Week 52
Trough Concentrations for LEN, TAB, and ZAB at Week 104
Measured: Week 104
Percentages of Participants With Antidrug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to TAB
Measured: Up to 92 Weeks
Percentages of Participants With ADAs and NAbs to ZAB.
Measured: Up to 92 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start14 Jul 2026
- Primary completionMar 2029 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683000
- Sponsor's protocol ID
- GS-US-536-6544
- Other IDs
- 2025-524336-19, 2025
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to a Regimen of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir Twice-Yearly in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens
- ClinicalTrials.gov ID
- NCT07683000
- Acronym / sponsor ID
- GS-US-536-6544
- Conditions
- HIV-1-infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2033 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to compare how effective a long-acting treatment of injectable combination of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) is versus continuing a daily oral HIV treatment in adults with HIV-1 whose virus is already well controlled, after 1 year (52 weeks) of treatment.
The primary objective of this study is to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus continuing an oral stable baseline regimen (SBR) in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1: Lenacapavir(LEN)+ Teropavimab(TAB)+ Zinlirvimab (ZAB) | Experimental | Drug: Lenacapavir, Drug: Lenacapavir Tablet, Drug: Teropavimab, Drug: ZinlirvimabParticipants 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 study 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. |
| Treatment Group 2: Stable Baseline Regimen (SBR) | Experimental | Drug: SBRParticipants will continue their SBR through at least Week 92. Oral SBRs will be taken per local prescribing information. After Week 92, eligible participants will have an option to switch to LEN + TAB + ZAB in the study 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria:
- 1) Proviral phenotypic susceptibility to both TAB and ZAB by the investigational protocol-defined assay at screening.
- Plasma HIV-1 RNA levels < 50 copies/mL at screening.
- 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.
Key exclusion criteria (27 listed)
- History of an opportunistic infection or illness indicative of Stage 3 HIV disease.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenacapavirAlso: LENAdministered subcutaneously | Drug | Treatment Group 1: Lenacapavir(LEN)+ Teropavimab(TAB)+ Zinlirvimab (ZAB) |
| Lenacapavir TabletAlso: TAB, GS-5423Administered orally | Drug | Treatment Group 1: Lenacapavir(LEN)+ Teropavimab(TAB)+ Zinlirvimab (ZAB) |
| TeropavimabAlso: TAB, GS-5423Administered intravenously (IV) | Drug | Treatment Group 1: Lenacapavir(LEN)+ Teropavimab(TAB)+ Zinlirvimab (ZAB) |
| ZinlirvimabAlso: GS-2872Administered IV | Drug | Treatment Group 1: Lenacapavir(LEN)+ Teropavimab(TAB)+ Zinlirvimab (ZAB) |
| SBRSBRs administered orally. SBRs include medicines like bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) or dolutegravir (DTG)+ tenofovir alafenamide (TAF)+ emtricitabine (FTC). | Drug | Treatment Group 2: Stable Baseline Regimen (SBR) |
Primary outcome
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Defined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm.
Time frame: Week 52
12 secondary outcomes
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 92 as Defined by the US FDA Snapshot Algorithm.
Time frame: Week 92
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm.
Time frame: Week 52
Proportion of Participants With HIV-1 RNA < 50 copies/mL at Week 92 as Determined by the US FDA Snapshot Algorithm.
Time frame: Week 92
Changes from Baseline in Clusters of Differentiation 4 (CD4)+ T-cell Counts at Week 52
Time frame: Baseline, Week 52
Changes from Baseline in CD4+ T-cell Counts at Week 92
Time frame: Baseline, Week 92
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Time frame: First dose up to 92 weeks
Percentage of Participants Prematurely Discontinuing Their Study Treatment due to an AE
Time frame: First dose up to 92 weeks
Trough Concentrations for LEN, TAB, and ZAB at Week 26
Time frame: Week 26
Trough Concentrations for LEN, TAB, and ZAB at Week 52
Time frame: Week 52
Trough Concentrations for LEN, TAB, and ZAB at Week 104
Time frame: Week 104
Percentages of Participants With Antidrug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to TAB
Time frame: Up to 92 Weeks
Percentages of Participants With ADAs and NAbs to ZAB.
Time frame: Up to 92 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for HIV-1-infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gilead Clinical Study Information Center contact
Gilead Study Director study director
Gilead Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lenacapavir, Lenacapavir Tablet and Teropavimab in people with HIV-1-infection, run by Gilead Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gilead Clinical Study Information Center (1-833-445-3230 (GILEAD-0), GileadClinicalTrials@gilead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Defined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm. (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.