Clinical trials
GS-US-536-5939
Identifier
NCT05729568
Link
https://clinicaltrials.gov/study/NCT05729568
Phase
Phase II
Status
Active, not recruiting
Sponsor
Gilead Sciences
More details
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.
Purpose
A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
Interventions
Intervention 1
Teropavimab
Intervention 2
Zinlirvimab
Intervention 3
Lenacapavir Tablet
Intervention 4
Lenacapavir Injection
Intervention 5
Antiretroviral Therapy
Countries
United States of America
Australia
Canada
Puerto Rico
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-05-15
Anticipated Date of Last Follow-up
2026-04-02
Estimated Primary Completion Date
Not provided
Estimated Completion Date
2030-12-01
Actual Primary Completion Date
2024-07-02
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Key Inclusion Criteria:
* 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.
* Doc
Health status
Negative to
: HCV, HBV
Positive to
: HIV
Study type
Interventional (clinical trial)
Enrollment
83
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Every 6 months
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Intravenous
Use case
Treatment
Key resources
|
Type
|
Title |
Content |
Link |
|
Link
|
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
|
|
https://www.askgileadmedical.com/docs/conference/Ogbuagu_CROI2025_oral_LEN+TAB+ZAB%20Ph2%20W26@pdf
|
|
Link
|
Positive Proof-of-Concept Data for Investigational Combination Regimen of Lenacapavir with Broadly Neutralizing Antibodies as a Potential Twice-Yearly Approach for the Treatment of HIV
|
|
https://www.gilead.com/news/news-details/2023/gilead-presents-positive-proof-of-concept-data-for-investigational-combination-regimen-of-lenacapavir-with-broadly-neutralizing-antibodies-as-a-potential-twice-yearly-approach-for-the-treatm
|
|
Link
|
Gilead Presents New HIV Treatment and Cure Research Data at CROI 2025, Including an Investigational Long-Acting, Twice-Yearly Therapy Option
|
|
https://www.gilead.com/news/news-details/2025/gilead-presents-new-hiv-treatment-and-cure-research-data-at-croi-2025-including-an-investigational-long-acting-twice-yearly-therapy-option
|
GS-US-536-5816
Identifier
NCT04811040
Link
https://clinicaltrials.gov/ct2/show/NCT04811040
Phase
Phase I
Status
Completed
Sponsor
Gilead Sciences
More details
Not provided
Purpose
Evaluate the safety and tolerability of a combination of the broadly neutralizing antibodies (bNAbs) teropavimab (formerly GS-5423) and GS-2872 in combination with the HIV capsid inhibitor lenacapavir
Interventions
Intervention 1
Drug: Oral Lenacapavir
Intervention 2
Drug: Subcutaneous Lenacapavir
Intervention 3
Biological: Teropavimab
Intervention 4
Biological: Zinlirvimab
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-04-08
Anticipated Date of Last Follow-up
2024-12-19
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-06-09
Actual Completion Date
2023-10-26
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
On first-line antiretroviral therapy (ART) for ≥ 2 years prior to screening. A change in ART regimen ≥ 28 days prior to screening for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed.
Health status
Positive to
: HIV
Negative to
: HCV, HBV
Other health status: No history of opportunistic infection or illness indicative of Stage 3 HIV disease; No comorbid condition(s) requiring ongoing immunosuppression.
Study type
Interventional (clinical trial)
Enrollment
32
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Double (Participant, Investigator). Clinical pharmacologist and sponsor are not masked to treatment assignment.
Frequency of administration
Other/Variable/Unknown
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Oral
Subcutaneous
Use case
Treatment
Key resources
Not provided
DAYBREAK-1 (GS-US-536-5938)
Identifier
NCT07682961
Link
https://clinicaltrials.gov/study/NCT07682961
Phase
Phase III
Status
Recruiting
Sponsor
Gilead Sciences
More details
The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment.
The primary objective of this study are to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV 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.
Purpose
Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
Interventions
Intervention 1
Lenacapavir(LEN)+ Teropavimab(TAB)+ Zinlirvimab (ZAB)
Dosage: oral LEN 600 mg, SC LEN 927 mg, and IV infusions of TAB & ZAB on D1. Participants will self-administer oral LEN 600 mg on D2. Every 26 weeks, participants receive SC LEN + IV inf. of TAB & ZAB til W92
Intervention 2
Active Comparator: Treatment Group 2: Cabotegravir (CAB) + Rilpivirine (RPV)
Dosage: 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.
Countries
United States of America
Australia
Japan
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
2026-07-01
Actual Start Date
2026-07-14
Anticipated Date of Last Follow-up
2026-08-13
Estimated Primary Completion Date
2029-03-01
Estimated Completion Date
2033-03-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Key Inclusion Criteria:
* 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.
* 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
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
590
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Every 6 months
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
NCT05612178
Identifier
NCT05612178
Link
https://clinicaltrials.gov/study/NCT05612178
Phase
Phase I
Status
Active, not recruiting
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
More details
Not provided
Purpose
Evaluate the safety and effects of repeated doses of 3BNC117-LS and 10-1074-LS on persistent viral reservoirs in people living with HIV who are currently receiving suppressive antiretroviral therapy.
Interventions
Intervention 1
Biological: 3BNC117-LS
Intervention 2
Biological: 10-1074-LS
Intervention 3
Other: Sterile Saline
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2023-07-26
Anticipated Date of Last Follow-up
2026-06-03
Estimated Primary Completion Date
2027-03-31
Estimated Completion Date
2027-03-31
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
No
Comments about the studied
populations
Adult persons of any sex or gender, aged 18 years to 70; with confirmed HIV-1 infection and receiving antiretroviral therapy with plasma HIV-1 RNA levels of < 50 copies/mL and no reported interruption of ART for 7 consecutive days or longer for at least 96 weeks.
Health status
Positive to
: HIV
Negative to
: HBV, HCV
Study type
Interventional (clinical trial)
Enrollment
105
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Triple (Participant, Care Provider, Investigator)
Frequency of administration
Other/Variable/Unknown
:
"Administered 3 times at 20-week intervals.
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
YCO-0971
Identifier
NCT03554408
Link
https://clinicaltrials.gov/study/NCT03554408
Phase
Phase I
Status
Completed
Sponsor
Rockefeller University
More details
Not provided
Purpose
Evaluate the pharmacokinetic profile, tolerability and safety of 10-1074-LS in the first clinical study administered individually or in combination with 3BNC117-LS to individuals with and without HIV.
Interventions
Intervention 1
Drug: Subcutaneous 10-1074-LS
Intervention 2
Drug: Subcutaneous 3BNC117-LS
Intervention 3
Drug: Intravenous 10-1074-LS
Intervention 4
Drug: Intravenous 3BNC117-LS
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2018-06-20
Anticipated Date of Last Follow-up
Not provided
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2021-02-04
Actual Completion Date
2021-02-04
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
Yes
Comments about the studied
populations
Study participants placed into groups of HIV-infected and HIV-uninfected individuals.
Inclusion criteria for HIV positive groups:
Males and females aged 18-65 who have documented HIV-1 infection and are currently receiving antiretroviral therapy with < 50 copies/ml plasma HIV-1 RNA levels and CD4+ T cell count of > 300 cells/μL.
Inclusion criteria for HIV negative groups:
Males and females aged 18-65 who have low risk for HIV infection and agree to implement two methods of effective contraception if sexually active.
Health status
Positive to
: HIV
Considered at low risk of
: HIV
Negative to
: HIV, HBV, HCV
Study type
Interventional (clinical trial)
Enrollment
77
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Double (Participant, Investigator)
Frequency of administration
Other/Variable/Unknown
:
"Dose escalation study
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Intravenous
Use case
Treatment
Key resources
Not provided
MCA-0994
Identifier
NCT04250636
Link
https://clinicaltrials.gov/study/NCT04250636
Phase
Phase I
Status
Completed
Sponsor
Rockefeller University
More details
Not provided
Purpose
Evaluate the antiviral activity, pharmacokinetics and safety of single intravenous infusions of the bNAbs 3BNC117-LS and 10-1074-LS in HIV-infected individuals who are not currently receiving ART.
Interventions
Intervention 1
Drug: 3BNC117-LS
Intervention 2
Drug: 10-1074-LS
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2020-10-13
Anticipated Date of Last Follow-up
Not provided
Estimated Primary Completion Date
Not provided
Estimated Completion Date
Not provided
Actual Primary Completion Date
2022-01-21
Actual Completion Date
2022-02-11
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
No
Comments about the studied
populations
Study participants are individuals with HIV-1 infection who have not received antiretroviral therapy (either by choice, intolerance or ART-naïvety) for at least 28 days prior to study enrolment with plasma HIV-1 RNA levels between 500 - 100,000 copies/mL and CD4+ T cell counts > 300 cells/μl.
Health status
Positive to
: HIV
Negative to
: HBV, HCV
Study type
Interventional (clinical trial)
Enrollment
6
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
None (Open Label)
Frequency of administration
Other/Variable/Unknown
:
"Single intravenous infusions of the long-acting bNAbs 10-1074-LS and 3BNC117-LS dosed at 30mg/kg.
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
RIO
Identifier
NCT04319367
Link
https://clinicaltrials.gov/study/NCT04319367
Phase
Phase II
Status
Recruiting
Sponsor
Imperial College London
More details
Not provided
Purpose
Evaluate whether the combination of 3BNC117-LS and 10-1074-LS can prevent HIV viral rebound after discontinuing early-initiation antiretroviral treatment in adults during primary HIV infection.
Interventions
Intervention 1
Drug: Investigational Medicinal Product (3BNC117-LS and 10-1074-LS)
Intervention 2
Drug: Placebo
Countries
United Kingdom
Denmark
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2021-05-17
Anticipated Date of Last Follow-up
2024-04-16
Estimated Primary Completion Date
2027-07-31
Estimated Completion Date
2027-07-31
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
No
Comments about the studied
populations
Individuals aged 18-60 who are currently receiving a stable antiretroviral therapy (ART) regimen resulting in an undetectable HIV viral load for a time period of at least one year, which commenced within three months of documented primary HIV infection.
Current CD+ T cell counts > 500 cells/µL with a nadir of CD4+ > 350 cells/µL are required.
Study participants were required to be vaccinated against COVID-19 at least 28 days before enrolment.
Health status
Positive to
: HIV
Negative to
: HBV, HCV, COVID 19
Study type
Interventional (clinical trial)
Enrollment
72
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Triple (Participant, Investigator, Outcomes Assessor)
Frequency of administration
Other/Variable/Unknown
:
"Single infusions of the long-acting bNAbs 10-1074-LS and 3BNC117-LS
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
RHIVIERA-02
Identifier
NCT05300035
Link
https://clinicaltrials.gov/study/NCT05300035
Phase
Phase II
Status
Recruiting
Sponsor
ANRS, Emerging Infectious Diseases
More details
Not provided
Purpose
Evaluate the efficacy of an intervention consisting of the long-acting broadly neutralising antibodies 3BNC117-LS and 10-1074-LS + ART in reducing HIV-1 replication during primary HIV-1 infection.
Interventions
Intervention 1
Drug: Recombinant human monoclonal antibodies (3BNC117-LS and 10-1074-LS)
Intervention 2
Drug: Placebo
Countries
France
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2024-04-11
Anticipated Date of Last Follow-up
2024-12-23
Estimated Primary Completion Date
2026-12-10
Estimated Completion Date
2028-12-10
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
No
Comments about the studied
populations
Study participants are individuals with confirmed HIV-1 infection aged 18-70 at screening and no prior history of hypersensitivity or contraindication to 10-1074-LS or 3BNC117-LS intravenous infusions.
Health status
Positive to
: HIV
Negative to
: HCV, HBV, TB, COVID 19
Study type
Interventional (clinical trial)
Enrollment
69
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Triple-blind masking
Masking description
Triple (Participant, Care Provider, Investigator)
Frequency of administration
Other/Variable/Unknown
:
"Dual intravenous infusion of the long-acting bNAbs 10-1074LS & 3BNC117LS between day 7 and 10.
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
IAVI C100
Identifier
NCT04173819
Link
https://clinicaltrials.gov/study/NCT04173819
Phase
Phase I/II
Status
Completed
Sponsor
International AIDS Vaccine Initiative
More details
Not provided
Purpose
Evaluate the safety and pharmacokinetics of the combination broadly neutralizing antibodies, 3BNC117-LS-J and 10-1074-LS-J, in healthy American and African Adults.
Interventions
Intervention 1
Biological: 3BNC117-LS-J
Intervention 2
Biological: 10-1074-LS-J
Intervention 3
Biological: Combination 3BNC117-LS-J and 10-1074-LS-J
Intervention 4
Biological: Placebo
Countries
United States of America
Kenya
Rwanda
South Africa
Uganda
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2019-01-25
Anticipated Date of Last Follow-up
2025-05-02
Estimated Primary Completion Date
2023-09-01
Estimated Completion Date
2023-09-01
Actual Primary Completion Date
2023-09-01
Actual Completion Date
2023-09-01
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
Unspecified
Accepts healthy individuals
Yes
Comments about the studied
populations
Healthy male and female individuals aged between 18-45 who are willing to undergo HIV testing, risk reduction counselling and receive HIV test results; in addition to maintaining low-risk behaviour for the entire trial duration.
Health status
Considered at low risk of
: HIV
Negative to
: HIV, HCV, HBV, TB
Study type
Interventional (clinical trial)
Enrollment
225
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Double-blind masking
Masking description
Double (Participant, Investigator)
Frequency of administration
Other/Variable/Unknown
:
"Single infusions of the long-acting bNAbs 10-1074-LS-J and 3BNC117-LS-J (either alone or in-combination at differing ratios).
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Subcutaneous
Intravenous
Use case
PrEP
Key resources
Not provided
MCA-1031
Identifier
NCT05245292
Link
https://clinicaltrials.gov/study/NCT05245292
Phase
Phase I
Status
Completed
Sponsor
Rockefeller University
More details
Not provided
Purpose
Evaluate the antiretroviral activity and safety of the broadly neutralising antibodies 3BNC117-LS and 10-1074-LS in combination with IL-15 superagonist complex N-803.
Interventions
Intervention 1
Drug: 3BNC117-LS
Intervention 2
Drug: 10-1074-LS
Intervention 3
Drug: N803
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2022-12-07
Anticipated Date of Last Follow-up
2026-03-30
Estimated Primary Completion Date
2025-12-31
Estimated Completion Date
2025-12-31
Actual Primary Completion Date
2025-12-09
Actual Completion Date
2025-12-31
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
No
Accepts lactating individuals
No
Accepts healthy individuals
No
Comments about the studied
populations
Study participants are males and females aged 18-70 with a confirmed HIV-1 infection who are currently receiving a stable antiretroviral treatment regimen (< 50 copies/ml plasma HIV-1 RNA) for at least 48 weeks with no reported continuous interruption of treatment greater than 7 days.
CD4+ T cell counts were required to be > 450 cells/μL at enrolment with a cell count nadir of ≥ 200 cells/μL and HIV-1 RNA plasma levels at < 20 copies/ml.
Health status
Negative to
: HBV, HCV
Positive to
: HIV
Study type
Interventional (clinical trial)
Enrollment
28
Allocation
Not provided
Intervention model
Single group assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
None (Open Label)
Frequency of administration
Other/Variable/Unknown
:
"Single intravenous infusions of the long-acting bNAbs 10-1074-LS (dosed at 10mg/kg) and 3BNC117-LS (dosed at 30mg/kg) on day zero.
"
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Use case
Treatment
Key resources
Not provided
DAYBREAK 2 (GS-US-536-6544)
Identifier
NCT07683000
Link
https://clinicaltrials.gov/study/NCT07683000
Phase
Phase III
Status
Recruiting
Sponsor
Gilead Sciences
More details
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.
Purpose
Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens
Interventions
Intervention 1
Lenacapavir
Intervention 2
Lenacapavir Tablet
Intervention 3
Teropavimab
Intervention 4
Zinlirvimab
Intervention 5
SBR
Countries
United States of America
Sites / Institutions
Not provided
Trials dates
Anticipated Start Date
Not provided
Actual Start Date
2026-07-14
Anticipated Date of Last Follow-up
2026-07-29
Estimated Primary Completion Date
2029-03-01
Estimated Completion Date
2033-03-01
Actual Primary Completion Date
Not provided
Actual Completion Date
Not provided
Studied populations
Age Cohort
Genders
Accepts pregnant individuals
Unspecified
Accepts lactating individuals
Unspecified
Accepts healthy individuals
No
Comments about the studied
populations
Key Inclusion Criteria:
* 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 plas
Health status
Not provided
Study type
Interventional (clinical trial)
Enrollment
590
Allocation
Randomized
Intervention model
Parallel Assignment
Intervention
model description
Not provided
Masking
Open label
Masking description
Not provided
Frequency of administration
Every 6 months
Studied LA-formulation(s)
Injectable
Studied route(s) of administration
Intravenous
Subcutaneous
Use case
Treatment
Key resources
Not provided
