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AzTrials

HIV-1-infectionPhase 3ARTISTRY-2NCT06333808

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

A Phase 3 study testing Bictegravir/Lenacapavir (BIC/LEN) FDC, Lenacapavir and B/F/TAF in people with HIV-1-infection, run by Gilead Sciences at 104 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH) who are successfully treated with… 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?
Bictegravir/Lenacapavir (BIC/LEN) FDC, Lenacapavir and B/F/TAF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
577 participants
Where
104 sitesin 14 countries
Study dates
25 Mar 2024to Dec 2029
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Currently receiving B/F/TAF for at least 6 months prior to screening.
  • If plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) measurements in the last 6 months prior to screening are available, all levels must be < 50 copies/mL.
  • At least one documented HIV-1 RNA level measured between 6 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.
  • Plasma HIV-1 RNA levels < 50 copies/mL at screening.
  • No documented or suspected resistance to BIC (including integrase strand-transfer inhibitor resistant (INSTI-R) mutations T66A/I/K, E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene).
  • No documented or suspected resistance to tenofovir alafenamide (TAF) (TAF; mutations K65R, K65N, K70E, Q151M or T69 insertion, or ≥ 3 of the following thymidine analog mutations [M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R] in the reverse transcriptase gene).
  • Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance.

Who cannot join

  • Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization.
  • Breastfeeding (nursing).
  • Prior use of, or exposure to, LEN.
  • Active, serious infections (other than HIV-1) requiring parenteral therapy < 30 days prior to randomization.
  • Active tuberculosis infection.
  • Acute hepatitis < 30 days before randomization.
Show all 22Show fewer
  • 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.
  • Known hypersensitivity to the study drug, its metabolites, or any formulation excipient.
  • History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
  • Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator.
  • Active malignancy requiring acute systemic therapy.
  • 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.
  • Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol.
  • Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor.
  • Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

104 sites in 14 countries.

104 sites in 14 countries

United States51 sites

  • Clinical Alliance For Research & Education - Infectious Diseases. LLC (CARE-ID)

    Annandale, Virginia, 22003

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • St Hope Foundation, Inc.

    Bellaire, Texas, 77401

  • Be Well Medical Center

    Berkeley, California, 48072

  • Pacific Oaks Medical Group

    Beverly Hills, California, 90211

  • Medical University of South Carolina (MUSC) Research Nexus

    Charleston, South Carolina, 29425

  • AIDS Arms, Inc. DBA Prism Health North Texas

    Dallas, Texas, 75208

  • North Texas Infectious Diseases Consultants, PA

    Dallas, Texas, 75246

  • Infectious Disease Specialists of Atlanta

    Decatur, Georgia, 30033

  • Midland Florida Infectious Diseases Specialists, PL - Orange City

    DeLand, Florida, 32720

  • Public Health Institute at Denver Health

    Denver, Colorado, 80204

  • Henry Ford Health

    Detroit, Michigan, 48202

  • AXCES Research Group, LLC

    El Paso, Texas, 79902

  • New York-Presbyterian Queens

    Flushing, New York, 11355

  • Therafirst Medical Center

    Fort Lauderdale, Florida, 33308

  • CAN Community Health

    Fort Lauderdale, Florida, 33316

  • Texas Centers for Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • The Brody School of Medicine at East Carolina University , ECU Adult Specialty Care

    Greenville, North Carolina, 27858

  • ID Care, LLC

    Hillsborough, New Jersey, 08844

  • The Crofoot research Center, INC.

    Houston, Texas, 77098

  • Rosedale Health and Wellness

    Huntersville, North Carolina, 28078

  • KC Care health Center

    Kansas City, Missouri, 64111

  • Ruane Clinical Research Group Inc.

    Los Angeles, California, 90036

  • Mercer University, Department of Internal Medicine

    Macon, Georgia, 31201

  • AIDS Healthcare Foundation - The Kinder Medical Group

    Miami, Florida, 33133

  • Schiff Center for liver Diseases/University of Miami

    Miami, Florida, 33136

  • Floridian Clinical Research

    Miami Lakes, Florida, 33016

  • Yale University School of Medicine (study visits)

    New Haven, Connecticut, 06510

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • New Jersey Medical School - Clinical Research Center

    Newark, New Jersey, 07103

  • Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care

    Oakland, California, 94609

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Bliss Healthcare

    Orlando, Florida, 32806

  • BIOS Clinical Research

    Palm Springs, California, 92262

  • AHF Pensacola

    Pensacola, Florida, 32503

  • Philadelphia FIGHT Community Health Centers

    Philadelphia, Pennsylvania, 19107

  • Pueblo Family Physicians

    Phoenix, Arizona, 85015

  • AXCES Research Group, LLC

    Salt Lake City, Utah, 84102

  • UCSD Anti Viral Research Centre (AVRC)

    San Diego, California, 92103

  • AXCES Research Group, LLC

    Santa Fe, New Mexico, 87505

  • CAN community Health

    Sarasota, Florida, 34237

  • Peter Shalit MD

    Seattle, Washington, 98104

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • Claudia T Martorell MD LLC dba The Research Institute

    Springfield, Massachusetts, 01105

  • Southampton Community Healthcare, Inc.

    St Louis, Missouri, 63139

  • Community Health care

    Tacoma, Washington, 98405

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Mills Clinical Research

    West Hollywood, California, 90046

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida, 33407

Other trials in United States

Germany7 sites

  • Praxis Dr. Knechten

    Aachen, 52062

  • Novopraxis Berlin

    Berlin, 10117

  • Praxis am Ebertplatz

    Cologne, 50668

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • Klinikum rechts der Isar der Technischen Universitaet Muenchen

    München, 81675

  • LMU Klinikum der Universität

    Munich, 80336

Other trials in Germany

Italy7 sites

  • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN

    Brescia, 25123

  • Azienda Ospedaliero Universitaria Ospedali Riuniti (Policlinico di Foggia)

    Foggia, 71122

  • IRCCS Ospedale San Raffaele

    Milan, 20127

  • Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo

    Monza, 20090

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    Pavia, 27100

  • Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS

    Roma, 00149

  • Fondazione Policlinico Universitario A Gemelli-Rome

    Roma, 00168

Other trials in Italy

Canada6 sites

  • Chronic Viral Illness Service/McGill University Health Centre (MUHC)

    Decarie Montreal, H4A 3J1

  • Clinique Médicale l'Actuel

    Montreal, H2L 4P9

  • The Ottawa Hospital - General Campus

    Ottawa, K1H 8L6

  • Regina General Hospital

    Regina, S4P 0W5

  • St. Paul's Hospital, John Ruedy Clinic-Immunodeficiency Clinic (JRC-IDC)

    Vancouver, V6Z1Y6

  • Cool Aid Community Health Centre

    Victoria, V8W 1M8

Other trials in Canada

Spain6 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona Barcelona, 8916

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 4103

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

United Kingdom5 sites

  • Liverpool University Hospitals NHS Foundation Trust, Royal Liverpool Hospital

    Liverpool, L7 8XP

  • King's College Hospital, Weston Education Centre

    London, SE5 9RS

  • Chelsea and Westminster Hospital NHS Foundation Trust, St Stephen's Centre, Chelsea and Westminster Hospital

    London, SW109NH

  • St Mary's Hospital - PPDS

    London, W2 1NY

  • Mortimer Market Centre

    London, WC1E 6JB

Other trials in United Kingdom

South Korea4 sites

  • Kyungpook National University Hospital

    Daegu, 41944

  • National Medical Center

    Seoul, *04564

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 137-701

Other trials in South Korea

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • National Taiwan University Hospital

    Taipei, 100

  • Taoyuan General Hospital, Ministry of Health and Welfare

    Taoyuan City, 33004

Other trials in Taiwan

Argentina3 sites

  • Helios Salud S.A.

    Buenos Aires, C1141ACG

  • Fundacion Huesped

    Buenos Aires, C1202ABB

  • Instituto CAICI SRL

    Santa Fe, S2000PBJ,

Other trials in Argentina

Australia3 sites

  • Taylor Square Private Clinic

    Darlinghurst, New South Wales, 2011

  • Alfred Hospital(Alfred Health)

    Melbourne, Victoria, 3004

  • Prahran Market Clinic

    South Yarra, Victoria, 3141

Other trials in Australia

Japan3 sites

  • National Hospital Organization Nagoya Medical Center

    Aichi, 460-0001

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Center Hospital of the National Center for Global Health and Medicine

    Tokyo, 162-0052

Other trials in Japan

Mexico2 sites

  • Unidad de Atencion Medica e Investigacion en Salud

    Mérida, 97070

  • ProcliniQ Investigacion Clinica Toriello Guerra, Tlalpan

    Mexico City, 6170

Other trials in Mexico

Puerto Rico2 sites

  • HOPE Clinical Research

    San Juan, PR, 00909

  • Proyecto ACTU

    San Juan, PR, 00935

Other trials in Puerto Rico

Dominican Republic1 site

  • Instituto Dominicano de Estudios Virologicos - IDEV

    Santo Domingo

Other trials in Dominican Republic

About this study

Official title: Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH) who are successfully treated with B/F/TAF (virologically suppressed).

The primary objective of this study is to evaluate the efficacy of switching to BIC/LEN (75/50 mg) FDC tablets versus continuing on B/F/TAF (50/200/25 mg) FDC tablets in virologically suppressed PWH.

Conditions
HIV-1-infection
Being tested
Bictegravir/Lenacapavir (BIC/LEN) FDC, Lenacapavir, B/F/TAF, Placebo to match B/F/TAF, Placebo to match BIC/LEN FDC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bictegravir/Lenacapavir (BIC/LEN) FDCDrug

    Also called Bixlenvo™

    Tablets administered orally without regard to food

  • LenacapavirDrug

    Also called GS-6207

    Tablets administered orally without regard to food

  • B/F/TAFDrug

    Also called Biktarvy ®

    Tablets administered orally without regard to food

  • Placebo to match B/F/TAFDrug

    Tablets administered orally without regard to food

  • Placebo to match BIC/LEN FDCDrug

    Tablets administered orally without regard to food

  • Placebo to match LenacapavirDrug

    Tablets administered orally without regard to food

Study groups in NCT06333808
Study groupRoleWhat they receive
Blinded Phase: Treatment Group 1: BIC/LEN 75/50 mgExperimentalParticipants will switch from bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg fixed-dose combination (FDC) tablets to bictegravir/lenacapavir (BIC/LEN) 75/50 mg FDC tablets + placebo-to-match (PTM) B/F/TAF tablets, administered orally, once daily up to 48 weeks. Participants will also receive a 2-day oral pharmacokinetic (PK) loading dose of LEN 600 mg on Days 1 and 2, in addition to the daily doses of BIC/LEN 75/50 mg and PTM B/F/TAF tablets starting on Day 1. At the end of blinded treatment (EBT) participants will enter the open label (OL) phase and continue to receive BIC/LEN 75 mg/50 mg FDC tablets through at least 48 weeks in the OL phase. At the OL Week 48, participants will be given an option to continue to receive BIC/LEN FDC tablets.
Receives: Drug: Bictegravir/Lenacapavir (BIC/LEN) FDC; Drug: Lenacapavir; Drug: Placebo to match B/F/TAF
Blinded Phase: Treatment Group 2: B/F/TAF 50/200/25 mgActive comparatorParticipants will continue with their B/F/TAF 50/200/25 mg tablets and start PTM BIC/LEN tablets on Day 1 administered orally, once daily up to 48 weeks. Participants will receive PTM oral LEN PK loading tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2). Participants who complete the EBT will be given an option to enter the OL phase to receive BIC/LEN FDC tablets.
Receives: Drug: B/F/TAF; Drug: Placebo to match BIC/LEN FDC; Drug: Placebo to match Lenacapavir
Open-label Phase: BIC/LEN 75/50mgExperimentalParticipants from Treatment Group 1 will receive BIC/LEN FDC tablets through at least OL Week 48. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets. Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets. Participants from Treatment Group 2 who enter the OL phase will also receive a 2-day oral loading dose of LEN 600 mg (2 × 300 mg LEN on Day 1 and on Day 2). All participants who enter the OL phase may continue to receive BIC/LEN FDC tablets daily until study drug is available or until Gilead Sciences (Gilead) elects to discontinue the study.
Receives: Drug: Bictegravir/Lenacapavir (BIC/LEN) FDC; Drug: Lenacapavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) ≥ 50 Copies/mL at Week 48 as Determined by the United States Food and Drug Administration (US FDA) Defined Snapshot Algorithm

    Participants who had the last available on-treatment HIV-1 RNA≥ 50 copies/mL in the Week 48 analysis window, or who did not have on-treatment HIV-1 RNA data in the Week 48 analysis window and participants who discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or who discontinued study drug prior to or in the Week 48 analysis window due to reasons other than adverse event (AE), death, or lack of efficacy and have the last available on-treatment HIV-1 RNA ≥ 50 copies/mL were included. The Week 48 window was between Days 295 and 378 (inclusively). Percentages were rounded off.

    Measured: Week 48

Secondary outcomes (11)

  1. Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm

    Participants who had the last available on-treatment HIV-1 RNA < 50 copies/mL in the Week 48 analysis window were included. The Week 48 window for snapshot algorithm was between Days 295 and 378 (inclusively). Percentages were rounded off.

    Measured: Week 48

  2. Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48

    Measured: Baseline, Week 48

  3. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) Through Week 48

    An AE was any untoward medical occurrence in a clinical study participant administered a study drug that did not necessarily had a causal relationship with the treatment. TEAEs were defined as any AE that begins on or after the date of first dose of study drug up to the date of last dose of study drug plus 60 days (for BIC/LEN FDC, Treatment Group 1) or 30 days (for B/F/TAF, Treatment Group 2) or any AE leading to study drug discontinuation. Percentages were rounded off.

    Measured: First dose date up to Week 48

  4. Treatment Group 1: Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the US FDA-Defined Snapshot Algorithm

    Measured: Week 96

  5. Treatment Group 1: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by US FDA-Defined Snapshot Algorithm

    Measured: Week 96

  6. Treatment Group 1: Change From Baseline in CD4 Cell Count at Week 96

    Measured: Week 96

  7. Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 96

    Measured: First dose date up to Week 96

  8. Treatment Group 1: Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 144 as Determined by the US FDA-Defined Snapshot Algorithm

    Measured: Week 144

  9. Treatment Group 1: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144 as Determined by US FDA-Defined Snapshot Algorithm

    Measured: Week 144

  10. Treatment Group 1: Change From Baseline in CD4 Cell Count at Week 144

    Measured: Week 144

  11. Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs Through Week 144

    Measured: First dose date up to Week 144

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2024
  2. Study start25 Mar 2024
  3. Primary completion27 Oct 2025
  4. Study completionDec 2029 (estimated)

Resources

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
Model description
Participants will be randomized in parallel in one of two treatment groups during the Blinded Phase. Participants in both treatment groups will be given the option to continue BIC/LEN FDC treatment during the Open-Label Phase.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
577 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06333808
Sponsor's protocol ID
GS-US-621-6290
Other IDs
2023-510022-33, jRCT2051240046, 2023
Acronym
ARTISTRY-2
Status last verified
Oct 2026
First submitted
20 Mar 2024
Last updated
5 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Meissner EG, Ramgopal M, Ruane PJ, Sanchez W, Crofoot G, Routy JP, Brinson C, DeJesus E, Martorell CT, Tellez M, Yokomaku Y, O'Reilly M, Lupo S, Schellberg S, Lezama-Mora JI, Chin B, Aizen K, D'Antoni ML, Huang H, Mponponsuo K, Montezuma-Rusca JM, Sklar P, Rhee M, Hung CC; ARTISTRY-2 Study Group. Safety and efficacy of switching to bictegravir-lenacapavir versus continuing bictegravir-emtricitabine-tenofovir alafenamide in virologically suppressed people with HIV-1 (ARTISTRY-2): a double-blind, multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet HIV. 2026 Aug;13(8):e538-e547. doi: 10.1016/S2352-3018(26)00078-0. Epub 2026 May 6.

    PubMed 42105781

  • Arora P, Hindman JT, West S, Ling J, Palaparthy R, Marathe DD. The effect of antacid and mineral supplements on bictegravir pharmacokinetics: results from a Phase 1, open-label, drug-drug interaction study. Antimicrob Agents Chemother. 2026 Jan 7;70(1):e0078125. doi: 10.1128/aac.00781-25. Epub 2025 Nov 28.

    PubMed 41313173

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bictegravir/Lenacapavir (BIC/LEN) FDC, Lenacapavir and B/F/TAF in people with HIV-1-infection, run by Gilead Sciences at 104 sites in 14 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 7 inclusion and 22 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in United States, Germany, Italy, Canada, Spain and 9 more countries. 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?

Yes. Results are posted in the registry (first posted 5 Nov 2026). 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-1 Ribonucleic Acid (HIV-1 RNA) ≥ 50 Copies/mL at Week 48 as Determined by the United States Food and Drug Administration (US FDA) Defined Snapshot Algorithm (time frame: Week 48). 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 NCT06333808, 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 5 Nov 2026.

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