HIV-1 InfectionPhase 2NCT05729568
A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
A Phase 2 study testing Teropavimab, Zinlirvimab and Lenacapavir Tablet in people with HIV-1 Infection, run by Gilead Sciences at 34 sites in 4 countries.
Trial summary
The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (TAB; GS-5423) and zinlirvimab (ZAB; GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Teropavimab, Zinlirvimab and Lenacapavir Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 34 sitesin 4 countries
- Study dates
- 15 May 2023to Dec 2030
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On stable oral antiretroviral therapy (ART) consisting of no more than 2 drug classes (with the exception of pharmacologic boosters cobicistat or ritonavir) for ≥ 1 year prior to screening visit 2. A change in ART regimen ≥ 28 days prior to screening visit 2 for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed.
- No clinically significant documented historical resistance to the current ART regimen with the exception of isolated nucleoside reverse transcriptase inhibitor mutations including M184V or ≤ 2 thymidine analog mutations (TAMs: M41L, D67N, K70R, L210W, T215Y, and/or K219Q).
- Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL at screening visit 2.
- Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 12 months preceding screening visit 2 (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Virologic elevations of ≥ 50 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable.
- Proviral phenotypic sensitivity to both teropavimab and zinlirvimab by the PhenoSense Assay (Monogram Biosciences).
- Screening clusters of differentiation 4 (CD4)+ T-cell count ≥ 200 cells/μL at screening visit 2.
Who cannot join
- Comorbid condition requiring ongoing immunosuppression.
- Hepatitis C virus (HCV) antibody positive and HCV RNA detectable.
- Evidence of current hepatitis B virus (HBV) infection regardless of HBV surface antigen status, at the screening visit 2.
- History of opportunistic infection or illness indicative of Stage 3 HIV disease.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
34 sites in 4 countries.
34 sites in 4 countries
United States29 sites
AXCES Research Group, LLC
Albuquerque, New Mexico, 87109
Clinical Alliance for Research & Education, Infectious Diseases LLC (CARE-ID)
Annandale, Virginia, 22003
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, 30308
University of Colorado Clinical and Translational Research Center
Aurora, Colorado, 80045
Central Texas Clinical Research
Austin, Texas, 78705
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Prisma Health - Clinical Research Unit
Columbia, South Carolina, 29203
AIDS Arms, Inc. DBA Prism Health North Texas
Dallas, Texas, 75208
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 32720
Duke University Health Center
Durham, North Carolina, 27710
AXCES Research Group, LLC
El Paso, Texas, 79902
Can Community Health Care
Fort Lauderdale, Florida, 33316
Midway Immunology and Research Center
Ft. Pierce, Florida, 34982
Regional Center for Infectious Disease Research
Greensboro, North Carolina, 27401
The Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27858
The Crofoot Research Center, INC
Houston, Texas, 77098
Rosedale Health and Wellness
Huntersville, North Carolina, 28078
Ruane Clinical Research Group, Inc.
Los Angeles, California, 90036
Mills Clinical Research
Los Angeles, California, 90069
St Jude Children's Research Hospital
Memphis, Tennessee, 38105
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, 06510
Orlando Immunology Center
Orlando, Florida, 32803
UC San Diego (UCSD) AntiViral Research Center (AVRC)
San Diego, California, 92103
Optimus Medical Group
San Francisco, California, 94102
Southhampton Healthcare, Inc
St Louis, Missouri, 63139
Montefiore Medical Center
The Bronx, New York, 10467
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Triple O Research Institute, P.A.
West Palm Beach, Florida, 33407
Australia3 sites
East Sydney Doctors
Darlinghurst, New South Wales, 2010
Alfred Hospital
Melbourne, Victoria, 3004
Holdsworth House Medical Practice
Sydney, New South Wales, 2010 NSW
About this study
Official title: A Phase 2 Randomized, Open-label Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With the Capsid Inhibitor Lenacapavir as Long-Acting Treatment Dosed Every 6 Months in Virologically Suppressed Adults With HIV-1 Infection
The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (TAB; GS-5423) and zinlirvimab (ZAB; GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection.
The purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, TAB and ZAB, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 50 copies/mL at Week 26.
Read the detailed description
Participants will be randomized in Treatment Groups 1 and 2 to receive LEN, TAB, and ZAB, with differing doses of TAB and ZAB between the 2 groups and in Treatment Group 3 to continue their baseline oral ART for 52 weeks. Eligible participants in Treatment Groups 1 through 3 will have the option of participating in the study extension phase to receive LEN, TAB and ZAB after completing study follow-up through Week 52.
Treatment Group 2 was removed prior to dosing of all groups during Protocol Amendment 2.
- Conditions
- HIV-1 Infection
- Being tested
- Teropavimab, Zinlirvimab, Lenacapavir Tablet, Lenacapavir Injection, Antiretroviral Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeropavimabDrug
Also called GS-5423, 3BNC117-LS
Administered intravenously
ZinlirvimabDrug
Also called GS-2872, 10-1074-LS
Administered intravenously
Lenacapavir TabletDrug
Also called GS-6207
Administered orally
Lenacapavir InjectionDrug
Also called GS-6207, Sunlenca®
Administered subcutaneously
Antiretroviral TherapyDrug
Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide.
| Study group | Role | What they receive |
|---|---|---|
| Randomized Phase Treatment Group 1: LEN + TAB + ZAB | Experimental | Participants will receive loading dose of lenacapavir (LEN) 600 mg tablets, orally, on Day 1 and Day 2. They will receive LEN 927 mg subcutaneous (SC) injection along with teropavimab (TAB) 2550 mg intravenous (IV) infusion and zinlirvimab (ZAB) 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL will be given the option to participate in the study extension phase. In the study extension phase, participants will continue to receive their randomized study drugs every 26 weeks. Receives: Drug: Teropavimab; Drug: Zinlirvimab; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection |
| Randomized Phase Treatment Group 3: SBR | Experimental | Participants in Stay on Baseline Regimen (SBR) group will continue their baseline oral antiretroviral therapy (ART) up to Week 52. Antiretroviral therapy will include drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study will switch from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants will switch to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52. Receives: Drug: Antiretroviral Therapy |
| Extension Phase: Treatment Group 1: LEN + TAB + ZAB | Experimental | At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL will be given the option to participate in the study extension phase. In the study extension phase, participants will receive LEN 927 mg SC, TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion. Receives: Drug: Teropavimab; Drug: Zinlirvimab; Drug: Lenacapavir Injection |
| Extension Phase Treatment Group 3: SBR | Experimental | At Week 52, participants in this group will be given the option to participate in the Extension Phase to switch from oral ART to LEN 927 mg SC, TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion, every 26 weeks at the dose specified for Treatment Group 1. Receives: Drug: Teropavimab; Drug: Zinlirvimab; Drug: Lenacapavir Tablet; Drug: Lenacapavir Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; or b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 26 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 26 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL.
Clopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off.
Measured: Week 26
Secondary outcomes (16)
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm
Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 52 analysis window; or b) who did not have on-treatment HIV-1 RNA data in the Week 52 analysis window and i) discontinued study drug prior to or in the Week 52 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 52 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 52 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL.
Clopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off.
Measured: Week 52
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm
Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 26 was analyzed using the US FDA-defined snapshot algorithm, which defined a participant's virologic outcome and included participants who had the last available on-treatment HIV-1 RNA < 50 copies/mL in the Week 26 analysis window.
The Clopper-Pearson exact method was used to calculate the 95% CI for the outcome measure of each treatment. Percentages were rounded off.
Measured: Week 26
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm
Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 52 was analyzed using the US FDA-defined snapshot algorithm, which defined a participant's virologic outcome and included participants who had the last available on-treatment HIV-1 RNA < 50 copies/mL in the Week 52 analysis window. The Clopper-Pearson exact method was used to calculate the 95% CI for the outcome measure of each treatment. Percentages were rounded off.
Measured: Week 52
Change From Baseline in Clusters of Differentiation 4 (CD4) + T-cell Counts at Week 26
Measured: Baseline, Week 26
Change From Baseline in CD4+ T-cell Counts at Week 52
Measured: Baseline, Week 52
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Measured: Up to approximately 6 years
Trough Concentration at Week 26 Predose for TAB and ZAB
Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
Measured: Week 26 predose
Trough Concentration at Week 26 Predose for LEN
Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
Measured: Week 26 predose
Trough Concentration at Week 52 Predose for TAB and ZAB
Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
Measured: Week 52 predose
Trough Concentration at Week 52 Predose for LEN
Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.
Measured: Week 52 predose
Pharmacokinetic (PK) Parameter: AUC0-tau for TAB and ZAB
AUC0-tau is defined as the partial area under the concentration versus time curve from time "0" to time "t".
Measured: Up to approximately 6 years
PK Parameter: t1/2 for TAB and ZAB
t1/2 is defined as the terminal elimination half-life.
Measured: Up to approximately 6 years
PK Parameter: Cmax for TAB and ZAB
Cmax is defined as the maximum observed concentration of drug.
Measured: Up to approximately 6 years
PK Parameter: Cmax for LEN
Cmax is defined as the maximum observed concentration of drug.
Measured: Up to approximately 6 years
PK Parameter: Tmax for TAB, ZAB, and LEN
Tmax is defined as the time (observed time point) of Cmax.
Measured: Up to approximately 6 years
Percentage of Participants With Treatment-emergent Anti-TAB and Anti-ZAB Antibodies
Anti-TAB and anti-ZAB antibodies incidence referred to the percentage of participants who have treatment-emergent anti-TAB and anti-ZAB antibodies among all participants evaluable for anti-drug antibody (ADA) incidence.
Measured: Up to approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start15 May 2023
- Primary completion2 Jul 2024
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
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
- NCT05729568
- Sponsor's protocol ID
- GS-US-536-5939
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2023
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mponponsuo K, McMahon JH, Gorgos L, Morales-Ramirez J, Workowski K, Brunetta J, Ogbuagu O, Collins SE, VanderVeen LA, Huang H, Baeten JM, Eron JJ. Efficacy and Safety of Lenacapavir, Teropavimab, and Zinlirvimab: Phase II Week 26 Primary Outcome [Oral 07]. Conference on Retroviruses and Opportunistic Infections (CROI); 2025 9-12 March, San Francisco, CA.
Ogbuagu O, Gaur A, McMahon JH, Gorgos L, Morales-Ramirez JO, Workowski K, Brunetta J, Mponponsuo K, Collins SE, VanderVeen LA, Zhang N, Huang H, Baeten JM, Eron J. Efficacy and safety of lenacapavir, teropavimab, and zinlirvimab: week-26 primary outcome results from a multicentre, open-label, randomised, active-controlled, phase 2 study. Lancet Microbe. 2026 Mar;7(3):101283. doi: 10.1016/j.lanmic.2025.101283. Epub 2026 Feb 17.
PubMed 41720146
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Open-label Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With the Capsid Inhibitor Lenacapavir as Long-Acting Treatment Dosed Every 6 Months in Virologically Suppressed Adults With HIV-1 Infection
- ClinicalTrials.gov ID
- NCT05729568
- Acronym / sponsor ID
- GS-US-536-5939
- Conditions
- HIV-1 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- Dec 2030 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Posted 15 Jul 2025
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 study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (TAB; GS-5423) and zinlirvimab (ZAB; GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection.
The purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, TAB and ZAB, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 50 copies/mL at Week 26.
Detailed description
Participants will be randomized in Treatment Groups 1 and 2 to receive LEN, TAB, and ZAB, with differing doses of TAB and ZAB between the 2 groups and in Treatment Group 3 to continue their baseline oral ART for 52 weeks. Eligible participants in Treatment Groups 1 through 3 will have the option of participating in the study extension phase to receive LEN, TAB and ZAB after completing study follow-up through Week 52.
Treatment Group 2 was removed prior to dosing of all groups during Protocol Amendment 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Randomized Phase Treatment Group 1: LEN + TAB + ZAB | Experimental | Drug: Teropavimab, Drug: Zinlirvimab, Drug: Lenacapavir Tablet, Drug: Lenacapavir InjectionParticipants will receive loading dose of lenacapavir (LEN) 600 mg tablets, orally, on Day 1 and Day 2. They will receive LEN 927 mg subcutaneous (SC) injection along with teropavimab (TAB) 2550 mg intravenous (IV) infusion and zinlirvimab (ZAB) 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL will be given the option to participate in the study extension phase. In the study extension phase, participants will continue to receive their randomized study drugs every 26 weeks. |
| Randomized Phase Treatment Group 3: SBR | Experimental | Drug: Antiretroviral TherapyParticipants in Stay on Baseline Regimen (SBR) group will continue their baseline oral antiretroviral therapy (ART) up to Week 52. Antiretroviral therapy will include drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study will switch from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants will switch to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52. |
| Extension Phase: Treatment Group 1: LEN + TAB + ZAB | Experimental | Drug: Teropavimab, Drug: Zinlirvimab, Drug: Lenacapavir InjectionAt Week 52, participants in this group with HIV-1 RNA < 50 copies/mL will be given the option to participate in the study extension phase. In the study extension phase, participants will receive LEN 927 mg SC, TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion. |
| Extension Phase Treatment Group 3: SBR | Experimental | Drug: Teropavimab, Drug: Zinlirvimab, Drug: Lenacapavir Tablet, Drug: Lenacapavir InjectionAt Week 52, participants in this group will be given the option to participate in the Extension Phase to switch from oral ART to LEN 927 mg SC, TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion, every 26 weeks at the dose specified for Treatment Group 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- On stable oral antiretroviral therapy (ART) consisting of no more than 2 drug classes (with the exception of pharmacologic boosters cobicistat or ritonavir) for ≥ 1 year prior to screening visit 2. A change in ART regimen ≥ 28 days prior to screening visit 2 for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed.
- No clinically significant documented historical resistance to the current ART regimen with the exception of isolated nucleoside reverse transcriptase inhibitor mutations including M184V or ≤ 2 thymidine analog mutations (TAMs: M41L, D67N, K70R, L210W, T215Y, and/or K219Q).
- Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) < 50 copies/mL at screening visit 2.
- Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 12 months preceding screening visit 2 (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). Virologic elevations of ≥ 50 copies/mL (transient detectable viremia or "blips") prior to screening are acceptable.
- Proviral phenotypic sensitivity to both teropavimab and zinlirvimab by the PhenoSense Assay (Monogram Biosciences).
Key exclusion criteria (5 listed)
- Comorbid condition requiring ongoing immunosuppression.
- Hepatitis C virus (HCV) antibody positive and HCV RNA detectable.
- Evidence of current hepatitis B virus (HBV) infection regardless of HBV surface antigen status, at the screening visit 2.
- History of opportunistic infection or illness indicative of Stage 3 HIV disease.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| TeropavimabAlso: GS-5423, 3BNC117-LSAdministered intravenously | Drug | Extension Phase Treatment Group 3: SBR, Extension Phase: Treatment Group 1: LEN + TAB + ZAB, Randomized Phase Treatment Group 1: LEN + TAB + ZAB |
| ZinlirvimabAlso: GS-2872, 10-1074-LSAdministered intravenously | Drug | Extension Phase Treatment Group 3: SBR, Extension Phase: Treatment Group 1: LEN + TAB + ZAB, Randomized Phase Treatment Group 1: LEN + TAB + ZAB |
| Lenacapavir TabletAlso: GS-6207Administered orally | Drug | Extension Phase Treatment Group 3: SBR, Randomized Phase Treatment Group 1: LEN + TAB + ZAB |
| Lenacapavir InjectionAlso: GS-6207, Sunlenca®Administered subcutaneously | Drug | Extension Phase Treatment Group 3: SBR, Extension Phase: Treatment Group 1: LEN + TAB + ZAB, Randomized Phase Treatment Group 1: LEN + TAB + ZAB |
| Antiretroviral TherapyAntiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide. | Drug | Randomized Phase Treatment Group 3: SBR |
Primary outcome
Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
Time frame: Week 26
Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; or b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 26 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 26 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL. Clopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off.
16 secondary outcomes
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 52
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 26
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 52
Change From Baseline in Clusters of Differentiation 4 (CD4) + T-cell Counts at Week 26
Time frame: Baseline, Week 26
Change From Baseline in CD4+ T-cell Counts at Week 52
Time frame: Baseline, Week 52
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 6 years
Trough Concentration at Week 26 Predose for TAB and ZAB
Time frame: Week 26 predose
Trough Concentration at Week 26 Predose for LEN
Time frame: Week 26 predose
Trough Concentration at Week 52 Predose for TAB and ZAB
Time frame: Week 52 predose
Trough Concentration at Week 52 Predose for LEN
Time frame: Week 52 predose
Pharmacokinetic (PK) Parameter: AUC0-tau for TAB and ZAB
Time frame: Up to approximately 6 years
PK Parameter: t1/2 for TAB and ZAB
Time frame: Up to approximately 6 years
PK Parameter: Cmax for TAB and ZAB
Time frame: Up to approximately 6 years
PK Parameter: Cmax for LEN
Time frame: Up to approximately 6 years
PK Parameter: Tmax for TAB, ZAB, and LEN
Time frame: Up to approximately 6 years
Percentage of Participants With Treatment-emergent Anti-TAB and Anti-ZAB Antibodies
Time frame: Up to approximately 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundMponponsuo K, McMahon JH, Gorgos L, Morales-Ramirez J, Workowski K, Brunetta J, Ogbuagu O, Collins SE, VanderVeen LA, Huang H, Baeten JM, Eron JJ. Efficacy and Safety of Lenacapavir, Teropavimab, and Zinlirvimab: Phase II Week 26 Primary Outcome [Oral 07]. Conference on Retroviruses and Opportunistic Infections (CROI); 2025 9-12 March, San Francisco, CA.
- Derived from this study: PubMed 41720146Ogbuagu O, Gaur A, McMahon JH, Gorgos L, Morales-Ramirez JO, Workowski K, Brunetta J, Mponponsuo K, Collins SE, VanderVeen LA, Zhang N, Huang H, Baeten JM, Eron J. Efficacy and safety of lenacapavir, teropavimab, and zinlirvimab: week-26 primary outcome results from a multicentre, open-label, randomised, active-controlled, phase 2 study. Lancet Microbe. 2026 Mar;7(3):101283. doi: 10.1016/j.lanmic.2025.101283. Epub 2026 Feb 17.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
34 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Teropavimab, Zinlirvimab and Lenacapavir Tablet in people with HIV-1 Infection, run by Gilead Sciences at 34 sites in 4 countries.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Australia, Canada, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm (time frame: Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05729568, which also lists 2 linked publications.
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 27 Apr 2026.