HIV-1 InfectionPhase 4ARTISTRY-3NCT07908446
Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV
A Phase 4 study testing BIC/LEN FDC, Lenacapavir and SBR in people with HIV-1 Infection, run by Gilead Sciences.
Trial summary
The goal of this clinical trial is to assess the effectiveness and safety of switching to bictegravir/lenacapavir (BIC/LEN) fixed-dose combination (FDC) compared with continuing stable baseline regimens (SBR) in virologically suppressed people with HIV. 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?
- BIC/LEN FDC, Lenacapavir and SBR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2028
- Phase
- Phase 4
- 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
- Currently receiving a SBR defined as (1) integrase strand-transfer inhibitor (INSTI) + 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) (excluding bictegravir/emtricitabine/tenofovir alafenamide (BIC/emtricitabine (FTC)/tenofovir alafenamide (TAF)), (2) boosted-protease inhibitor (PI) + 2 NRTIs, (3) nonnucleoside reverse transcriptase inhibitor (NNRTI) + 2 NRTIs, (4) dolutegravir (DTG)/RPV or (5) cabotegravir (CAB)/rilpivirine (RPV) for at least 3 months without switch prior to screening, and willing to continue their SBR through at least Week 24.
- HIV-1 RNA < 50 copies/mL for ≥ 3 months before screening
- Estimated creatinine clearance (eCLcr) rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) at screening
- Plasma HIV-1 RNA levels < 50 copies/mL at screening
Who cannot join
- Actively pregnant or breastfeeding (nursing)
- Chronic hepatitis B virus (HBV)
- Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
- Currently receiving renal replacement therapy (eg, hemodialysis)
- Documented or suspected resistance to BIC
- History of, or current severe decompensated cirrhosis
Show all 10Show fewer
- Requirement for ongoing therapy with any prohibited medications listed for BIC/LEN FDC
- Prior use of, or exposure to, LEN
- Ongoing treatment with BIC/FTC/TAF
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
About this study
Official title: Phase 4, Randomized, Open-label, Non-inferiority Trial of Bictegravir/Lenacapavir Fixed-dose Combination (BIC/LEN FDC) Versus Stable Baseline Regimens (SBR) in Virologically Suppressed (VS) People With HIV (PWH)
The goal of this clinical trial is to assess the effectiveness and safety of switching to bictegravir/lenacapavir (BIC/LEN) fixed-dose combination (FDC) compared with continuing stable baseline regimens (SBR) in virologically suppressed people with HIV.
The primary objective of this study is to evaluate the efficacy of switching to BIC/LEN (75/50 mg) fixed-dose combination (FDC) tablets versus continuing their stable baseline regimen (SBR) in virologically suppressed people with HIV.
- Conditions
- HIV-1 Infection
- Being tested
- BIC/LEN FDC, Lenacapavir, SBR
- Keywords
- Bictegravir, Lenacapavir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIC/LEN FDCDrug
Also called Bixlenvo™
Tablet administered orally
LenacapavirDrug
Also called LEN
Tablet administered orally
SBRDrug
SBR will include approved ARTs like: integrase strand-transfer inhibitor (INSTI) + 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs), excluding bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), boosted-protease inhibitor (PI) + 2 NRTIs, nonnucleoside reverse transcriptase inhibitor (NNRTI) + 2 NRTIs, or dolutegravir (DTG)/rilpivirine (RPV) or cabotegravir (CAB) + RPV
| Study group | Role | What they receive |
|---|---|---|
| Immediate Switch Arm: BIC/LEN FDC | Experimental | Participants will switch to BIC/LEN (75 mg/50mg) FDC tablets once daily starting on Day 1. Participants will receive a 2-day oral loading dose regimen of LEN 600 mg on Days 1 and 2, in addition to the once-daily doses of BIC/LEN FDC starting on Day 1, up to Week 48. Receives: Drug: BIC/LEN FDC; Drug: Lenacapavir |
| Delayed Switch Arm: Stable Baseline Regimen (SBR) | Active comparator | Participants will remain on their existing SBR antiretroviral therapy (ART) regimen from Day 1 through Week 24.
At Week 24, they will switch to BIC/LEN (75 mg/50 mg) FDC tablets once daily. At the time of BIC/LEN FDC initiation, participants will receive a 2-day oral loading dose regimen of LEN 600 mg on Day 1 and 2, in addition to the once-daily doses of BIC/LEN FDC starting at the time of switch, up to Week 48. Receives: Drug: BIC/LEN FDC; Drug: Lenacapavir; 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 Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 24, as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm
Measured: Week 24
Secondary outcomes (11)
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 using the US FDA-defined snapshot algorithm
Measured: Week 48
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the US FDA-Defined Snapshot Algorithm
Measured: Week 24
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the US FDA-Defined Snapshot Algorithm
Measured: Week 48
Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 24
Measured: Baseline, Week 24
Change From Baseline in CD4 Cell Count at Week 48
Measured: Baseline, Week 48
Percentage of Participants Experiencing Treatment-Emergent Grade 3 or 4 Adverse Events (AEs)
Measured: First dose date up to Week 48 plus 60 days
Percentage of Participants Experiencing Treatment-Emergent Serious Adverse events (SAEs)
Measured: First dose date up to Week 48 plus 60 days
Percentage of Participants Experiencing Treatment-Emergent AEs Leading to Discontinuation of Study Drug Through Week 48
Measured: Up to week 48
Change From Baseline in Patient-Reported Experience and Satisfaction Score, as Assessed by the Questionnaire to Understand the Experience and Satisfaction in a Study in HIV-Treatment (QUEST-HIV-T) at Week 24
The QUEST-HIV-T is a patient-reported outcome (PRO) measure that evaluates experience and satisfaction in a clinical study for HIV. The measure consists of 16-item that is intended to be completed by PWH during an active treatment period using a recall period of "the past 7 days." The QUEST-HIV-T utilizes 5-point verbal descriptor scales (Not at all-Extremely, Very satisfied-Very dissatisfied).
Measured: Baseline, Week 24
Change From Baseline in Patient-Reported Experience and Satisfaction Score, as Assessed by the Questionnaire to Understand the Experience and Satisfaction in a Study in HIV-Treatment (QUEST-HIV-T) at Week 48
Measured: Baseline, Week 48
Proportion of Participants Reporting a Preference for BIC/LEN FDC Compared with Previous SBR, as Assessed by the HIV-Treatment Preference Questionnaire (HIV-TPQ) at Week 48
The HIV-Treatment Preference Questionnaire (HIV-TPQ) is a PRO measure designed to evaluate participants' preference between treatment received prior to the study entry and the clinical study intervention. The HIV-TPQ assesses preference across multiple treatment attributes. The overall preference item uses a 3-point categorical response scale (Treatment before the study, Study treatment, No preference). All remaining items use a 5-point verbal descriptor scale (Very much prefer treatment before the study-Very much prefer study intervention).
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionNov 2028 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 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
- NCT07908446
- Sponsor's protocol ID
- GS-US-621-8145
- Acronym
- ARTISTRY-3
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4, Randomized, Open-label, Non-inferiority Trial of Bictegravir/Lenacapavir Fixed-dose Combination (BIC/LEN FDC) Versus Stable Baseline Regimens (SBR) in Virologically Suppressed (VS) People With HIV (PWH)
- ClinicalTrials.gov ID
- NCT07908446
- Acronym / sponsor ID
- ARTISTRY-3 / GS-US-621-8145
- Conditions
- HIV-1 Infection
- Keywords
- Bictegravir, Lenacapavir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 2 Nov 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 trial is to assess the effectiveness and safety of switching to bictegravir/lenacapavir (BIC/LEN) fixed-dose combination (FDC) compared with continuing stable baseline regimens (SBR) in virologically suppressed people with HIV.
The primary objective of this study is to evaluate the efficacy of switching to BIC/LEN (75/50 mg) fixed-dose combination (FDC) tablets versus continuing their stable baseline regimen (SBR) in virologically suppressed people with HIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Switch Arm: BIC/LEN FDC | Experimental | Drug: BIC/LEN FDC, Drug: LenacapavirParticipants will switch to BIC/LEN (75 mg/50mg) FDC tablets once daily starting on Day 1. Participants will receive a 2-day oral loading dose regimen of LEN 600 mg on Days 1 and 2, in addition to the once-daily doses of BIC/LEN FDC starting on Day 1, up to Week 48. |
| Delayed Switch Arm: Stable Baseline Regimen (SBR) | Active comparator | Drug: BIC/LEN FDC, Drug: Lenacapavir, Drug: SBRParticipants will remain on their existing SBR antiretroviral therapy (ART) regimen from Day 1 through Week 24. At Week 24, they will switch to BIC/LEN (75 mg/50 mg) FDC tablets once daily. At the time of BIC/LEN FDC initiation, participants will receive a 2-day oral loading dose regimen of LEN 600 mg on Day 1 and 2, in addition to the once-daily doses of BIC/LEN FDC starting at the time of switch, up to Week 48. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Currently receiving a SBR defined as (1) integrase strand-transfer inhibitor (INSTI) + 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) (excluding bictegravir/emtricitabine/tenofovir alafenamide (BIC/emtricitabine (FTC)/tenofovir alafenamide (TAF)), (2) boosted-protease inhibitor (PI) + 2 NRTIs, (3) nonnucleoside reverse transcriptase inhibitor (NNRTI) + 2 NRTIs, (4) dolutegravir (DTG)/RPV or (5) cabotegravir (CAB)/rilpivirine (RPV) for at least 3 months without switch prior to screening, and willing to continue their SBR through at least Week 24.
- HIV-1 RNA < 50 copies/mL for ≥ 3 months before screening
- Estimated creatinine clearance (eCLcr) rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) at screening
- Plasma HIV-1 RNA levels < 50 copies/mL at screening
Key exclusion criteria (10 listed)
- Actively pregnant or breastfeeding (nursing)
- Chronic hepatitis B virus (HBV)
- Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
- Currently receiving renal replacement therapy (eg, hemodialysis)
- Documented or suspected resistance to BIC
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 |
|---|---|---|
| BIC/LEN FDCAlso: Bixlenvo™Tablet administered orally | Drug | Delayed Switch Arm: Stable Baseline Regimen (SBR), Immediate Switch Arm: BIC/LEN FDC |
| LenacapavirAlso: LENTablet administered orally | Drug | Delayed Switch Arm: Stable Baseline Regimen (SBR), Immediate Switch Arm: BIC/LEN FDC |
| SBRSBR will include approved ARTs like: integrase strand-transfer inhibitor (INSTI) + 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs), excluding bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), boosted-protease inhibitor (PI) + 2 NRTIs, nonnucleoside reverse transcriptase inhibitor (NNRTI) + 2 NRTIs, or dolutegravir (DTG)/rilpivirine (RPV) or cabotegravir (CAB) + RPV | Drug | Delayed Switch Arm: Stable Baseline Regimen (SBR) |
Primary outcome
Proportion of Participants With HIV-1 Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 24, as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm
Time frame: Week 24
11 secondary outcomes
Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 using the US FDA-defined snapshot algorithm
Time frame: Week 48
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the US FDA-Defined Snapshot Algorithm
Time frame: Week 24
Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the US FDA-Defined Snapshot Algorithm
Time frame: Week 48
Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 24
Time frame: Baseline, Week 24
Change From Baseline in CD4 Cell Count at Week 48
Time frame: Baseline, Week 48
Percentage of Participants Experiencing Treatment-Emergent Grade 3 or 4 Adverse Events (AEs)
Time frame: First dose date up to Week 48 plus 60 days
Percentage of Participants Experiencing Treatment-Emergent Serious Adverse events (SAEs)
Time frame: First dose date up to Week 48 plus 60 days
Percentage of Participants Experiencing Treatment-Emergent AEs Leading to Discontinuation of Study Drug Through Week 48
Time frame: Up to week 48
Change From Baseline in Patient-Reported Experience and Satisfaction Score, as Assessed by the Questionnaire to Understand the Experience and Satisfaction in a Study in HIV-Treatment (QUEST-HIV-T) at Week 24
Time frame: Baseline, Week 24
Change From Baseline in Patient-Reported Experience and Satisfaction Score, as Assessed by the Questionnaire to Understand the Experience and Satisfaction in a Study in HIV-Treatment (QUEST-HIV-T) at Week 48
Time frame: Baseline, Week 48
Proportion of Participants Reporting a Preference for BIC/LEN FDC Compared with Previous SBR, as Assessed by the HIV-Treatment Preference Questionnaire (HIV-TPQ) at Week 48
Time frame: Week 48
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 2 Nov 2026.
- 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.
Gilead Clinical Study Information Center contact
Gilead Study Director study director
Gilead Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BIC/LEN FDC, Lenacapavir and SBR in people with HIV-1 Infection, run by Gilead Sciences.
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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 24, as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm (time frame: Week 24). 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 2 Nov 2026.