HIV-1 InfectionPhase 3NCT05630755
A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)
A Phase 3 study testing DOR/ISL and BIC/FTC/TAF in people with HIV-1 Infection, run by Merck Sharp & Dohme LLC at 49 sites in 6 countries.
Trial summary
The primary objectives of this study are to evaluate the antiretroviral activity of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued… 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?
- DOR/ISL and BIC/FTC/TAF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 514 participants
- Where
- 49 sitesin 6 countries
- Study dates
- 17 Feb 2023to 4 Aug 2028
- 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
- Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL
- Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen
- Female is not a participant of childbearing potential (POCBP); or if a participant of childbearing potential, not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration
Who cannot join
- Has HIV-2 infection
- Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
- Has active hepatitis B virus (HBV) infection
- Has chronic hepatitis C virus (HCV) infection with laboratory values consistent with cirrhosis
- Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers
Show all 9Show fewer
- Has a documented or known virologic resistance to DOR
- Has taken long-acting HIV therapy at any time (e.g., cabotegravir, lenacapavir)
- Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period except those currently enrolled in the comparator arm of an ongoing DOR/ISL study
Trial locations and contacts
49 sites in 6 countries.
49 sites in 6 countries
United States24 sites
Central Texas Clinical Research ( Site 1413)
Austin, Texas, 78705
St Hope Foundation ( Site 1410)
Bellaire, Texas, 77401
Be Well Medical Center ( Site 1408)
Berkley, Michigan, 48072
Pacific Oaks Medical Group ( Site 1400)
Beverly Hills, California, 90211
AccessHealth MA ( Site 1419)
Boston, Massachusetts, 02129
Prism Health North Texas, Oak Cliff Health Center ( Site 1409)
Dallas, Texas, 75205
North Texas Infectious Diseases Consultants, P.A ( Site 1404)
Dallas, Texas, 75246
Infectious Disease Specialists of Atlanta ( Site 1403)
Decatur, Georgia, 30033
Therafirst Medical Center ( Site 1402)
Fort Lauderdale, Florida, 33308
Texas Centers for Infectious Disease Associates ( Site 1406)
Fort Worth, Texas, 76104
Midway Immunology and Research Center ( Site 1401)
Ft. Pierce, Florida, 34982
Regional Center for Infectious Disease Research ( Site 1435)
Greensboro, North Carolina, 27401
The Crofoot Research Center ( Site 1424)
Houston, Texas, 77098
KC CARE Health Center-Clinical Trials ( Site 1422)
Kansas City, Missouri, 64111
Las Vegas Research Center ( Site 1436)
Las Vegas, Nevada, 89106
DCOL Center for Clinical Research ( Site 1415)
Longview, Texas, 75605
Ruane Clinical Research Group, Inc ( Site 1414)
Los Angeles, California, 90036
Mills Clinical Research ( Site 1433)
Los Angeles, California, 90069
Mercer University, Department of Internal Medicine ( Site 1411)
Macon, Georgia, 31201
AHF The Kinder Medical Group ( Site 1426)
Miami, Florida, 33133
Orlando Immunology Center ( Site 1407)
Orlando, Florida, 32803
Pueblo Family Physicians ( Site 1425)
Phoenix, Arizona, 85015
Whitman-Walker Institute ( Site 1431)
Washington D.C., District of Columbia, 20005
Triple O Research Institute, P.A ( Site 1417)
West Palm Beach, Florida, 33407
United Kingdom9 sites
Queen Elizabeth Hospital Birmingham ( Site 5809)
Birmingham, England, B15 2TH
Southmead Hospital ( Site 5805)
Bristol, Bristol, City of, BS10 5NB
University Hospital of Wales ( Site 5803)
Cardiff, Wales, CF14 4XW
Royal Liverpool University Hospital ( Site 5812)
Liverpool, England, L7 8XP
Royal London Hospital ( Site 5800)
London, England, E1 1BB
Royal Free Hospital ( Site 5801)
London, England, NW32QG
Guy's & St Thomas' NHS Foundation Trust ( Site 5808)
London, London, City of, SE1 9RT
The Mortimer Market Centre for Sexual Health and HIV Research ( Site 5810)
London, London, City of, WC1E 6JB
Royal Berkshire Hospital ( Site 5813)
Reading, RG1 5AN
Australia5 sites
Holdsworth House Medical Practice - Brisbane ( Site 6201)
Brisbane, Queensland, 4006
Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 6204)
Brisbane, Queensland, 4029
Holdsworth House Medical Practice ( Site 6200)
Darlinghurst, New South Wales, 2010
Prahran Market Clinic ( Site 6202)
Melbourne, Victoria, 3181
St Vincent's Hospital-IBAC ( Site 6203)
Sydney, New South Wales, 2010
Chile4 sites
Clínica Universidad de Los Andes ( Site 2206)
Santiago, Region M. de Santiago, 7620001
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 2200)
Santiago, Region M. de Santiago, 8380420
Clinica Universidad Catolica del Maule ( Site 2204)
Talca, Maule Region, 3465584
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 2205)
Temuco, Araucania, 4781151
Israel4 sites
Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 4801)
Haifa, 3109601
Hadassah Medical Center-Infecious Disease ( Site 4802)
Jerusalem, 9120
Sheba Medical Center-HIV unit ( Site 4803)
Ramat Gan, 5262100
Sourasky Medical Center ( Site 4804)
Tel Aviv, 64239
Japan3 sites
National Hospital Organization Nagoya Medical Center ( Site 6603)
Nagoya, Aichi-ken, 460-0001
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 66
Osaka, 540-0006
Center Hospital of the National Center for Global Health and Medicine ( Site 6601)
Shinjyuku-ku, Tokyo, 162-8655
About this study
Official title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
The primary objectives of this study are to evaluate the antiretroviral activity of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF, through Week 48. The primary hypotheses are that (1) DOR/ISL is non-inferior to continued BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority; and (2) DOR/ISL is superior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.
- Conditions
- HIV-1 Infection
- Being tested
- DOR/ISL, BIC/FTC/TAF, Placebo to BIC/FTC/TAF, Placebo to DOR/ISL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOR/ISLDrug
Also called MK-8591A, Doravirine/Islatravir
DOR/ISL 100 mg/0.25 mg oral tablets once daily
BIC/FTC/TAFDrug
Also called Bictegravir/Emtricitabine/Tenofovir Alafenamide
BIC/FTC/TAF 50 mg/200 mg/25 mg oral tablets once daily
Placebo to BIC/FTC/TAFDrug
0 mg oral tablets once daily
Placebo to DOR/ISLDrug
0 mg oral tablets once daily
| Study group | Role | What they receive |
|---|---|---|
| DOR/ISL and Placebo to BIC/FTC/TAF | Experimental | Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first). Receives: Drug: DOR/ISL; Drug: Placebo to BIC/FTC/TAF |
| BIC/FTC/TAF and Placebo to DOR/ISL | Active comparator | Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first). Receives: Drug: BIC/FTC/TAF; Drug: Placebo to DOR/ISL |
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 48
HIV-1 RNA levels in blood samples taken at each visit were measured with a reliable lower limit of quantification of <50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Measured: Week 48
Percentage of Participants Who Experience Adverse Events (AEs) Through Week 48
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE is reported.
Measured: Up to Week 48
Percentage of Participants Who Discontinue Study Intervention Due to AEs Through Week 48
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE is reported.
Measured: Up to Week 48
Secondary outcomes (16)
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
HIV-1 RNA levels in blood samples taken at each visit were measured with a reliable lower limit of quantification of <50 copies/mL. The percentage of participants with HIV-1 RNA <200 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Measured: Week 48
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
HIV-1 RNA levels in blood samples taken at each visit were measured with a reliable lower limit of quantification of <50 copies/mL. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Measured: Week 48
Change From Baseline in Cluster of Differentiation 4-positive (CD4+) T-cell Count at Week 48
Plasma CD4+ T-Cell Count was measured in cells/mm^3 for baseline and 48 weeks. Baseline measurements were defined as the Day 1 value of each participant. The change from baseline to Week 48 and corresponding 2-sided 95% confidence intervals were calculated based on cLDA models adjusted by treatment group, time, and the interaction of time-by-treatment group.
Measured: Baseline at Day 1 and Week 48
Percentage of Participants With Treatment-Emergent, Resistance-associated Substitutions at Week 48
Participants with clinically significant confirmed viremia [2 consecutive occurences 4 weeks (+-1 week) apart of HIV-1 RNA ≥200 copies/mL at any time during the study] or who discontinue study intervention for another reason with HIV-1 RNA ≥200 copies/mL at the time of discontinuation met the criteria for post-baseline resistance testing. Per protocol, participants with HIV-1 RNA ≥400 copies/mL or any participant for whom available genotypic or phenotypic data show evidence of resistance, irrespective of viral load were included in the resistance analysis subset. Plasma samples were collected for genotypic and phenotypic HIV-1 viral drug resistance testing and used to assess resistance-associated substitutions and virus susceptibility to study intervention. The percentage of participants in the resistance analysis subset with treatment-emergent resistance-associated substitutions to the study intervention is presented.
Measured: Up to Week 48
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 96
Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 will be reported.
Measured: Week 96
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96 will be reported.
Measured: Week 96
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 will be reported.
Measured: Week 96
Change From Baseline in CD4+ T-cell Count at Week 96
Mean change from baseline at Day 1 in CD4+ T-cell count at Week 96 will be reported.
Measured: Baseline at Day 1 and Week 96
Number of Participants With Viral Drug Resistance Mutations at Week 96
Number of participants with evidence of viral drug resistance-associated substitutions at Week 96 will be reported.
Measured: Week 96
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 144
Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 144 will be reported.
Measured: Week 144
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 144
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 144 will be reported.
Measured: Week 144
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 144
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 144 will be reported.
Measured: Week 144
Change From Baseline in CD4+ T-cell Count at Week 144
Mean change from baseline at Day 1 in CD4+ T-cell count at Week 144 will be reported.
Measured: Baseline at Day 1 and Week 144
Number of Participants With Viral Drug Resistance Mutations at Week 144
Number of participants with evidence of viral drug resistance-associated substitutions at Week 144 will be reported.
Measured: Week 144
Percentage of Participants Who Experience AEs Through Week 144
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to Week 144
Percentage of Participants Who Discontinue Study Intervention Due to AEs Through Week 144
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: 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.
- First posted30 Nov 2022
- Study start17 Feb 2023
- Primary completion25 Oct 2024
- Study completion4 Aug 2028 (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 Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630755
- Sponsor's protocol ID
- 8591A-052
- Other IDs
- MK-8591A-052, 2022-502079-49-00, jRCT2051230003, U1111-1283-0949
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2022
- Last updated
- 18 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Diamond TL, Grandhi A, Fuszard M, Xu Y, Nwoke U, Zhang Y, Klopfer SO, Eves K, Benner J, Li M, Greaves W, Lahoulou R, Kim J, Fox MC, Asante-Appiah E. Switching to Daily Doravirine/Islatravir (100/0.25 mg) Maintains Viral Suppression Through Week 48 Despite Baseline Non-Nucleoside Reverse Transcriptase Inhibitor Resistance-Associated Mutations or M184I/V in Proviral DNA. J Infect Dis. 2026 May 29:jiag257. doi: 10.1093/infdis/jiag257. Online ahead of print.
PubMed 42213454Colson AE, Mills AM, Ramgopal MN, Bettacchi C, Osiyemi OO, Hinestrosa F, Crofoot G, Katner HP, Gatanaga H, Johnson M, Diamond TL, Barninger E, Eves K, Su FH, Xu Y, Klopfer SO, Stamm LM, Fox MC, Lahoulou R. Switch to fixed-dose doravirine (100 mg) and islatravir (0.25 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, multicentre, randomised, controlled, double-blind, non-inferiority trial. Lancet. 2026 Feb 7;407(10528):611-621. doi: 10.1016/S0140-6736(25)01948-8.
PubMed 41654375
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
- ClinicalTrials.gov ID
- NCT05630755
- Acronym / sponsor ID
- 8591A-052
- Conditions
- HIV-1 Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 514 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 4 Aug 2028 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Posted 18 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to evaluate the antiretroviral activity of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF, through Week 48. The primary hypotheses are that (1) DOR/ISL is non-inferior to continued BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority; and (2) DOR/ISL is superior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DOR/ISL and Placebo to BIC/FTC/TAF | Experimental | Drug: DOR/ISL, Drug: Placebo to BIC/FTC/TAFParticipants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first). |
| BIC/FTC/TAF and Placebo to DOR/ISL | Active comparator | Drug: BIC/FTC/TAF, Drug: Placebo to DOR/ISLParticipants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL
- Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen
- Female is not a participant of childbearing potential (POCBP); or if a participant of childbearing potential, not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration
Key exclusion criteria (9 listed)
- Has HIV-2 infection
- Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
- Has active hepatitis B virus (HBV) infection
- Has chronic hepatitis C virus (HCV) infection with laboratory values consistent with cirrhosis
- Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
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 |
|---|---|---|
| DOR/ISLAlso: MK-8591A, Doravirine/IslatravirDOR/ISL 100 mg/0.25 mg oral tablets once daily | Drug | DOR/ISL and Placebo to BIC/FTC/TAF |
| BIC/FTC/TAFAlso: Bictegravir/Emtricitabine/Tenofovir AlafenamideBIC/FTC/TAF 50 mg/200 mg/25 mg oral tablets once daily | Drug | BIC/FTC/TAF and Placebo to DOR/ISL |
| Placebo to BIC/FTC/TAF0 mg oral tablets once daily | Drug | DOR/ISL and Placebo to BIC/FTC/TAF |
| Placebo to DOR/ISL0 mg oral tablets once daily | Drug | BIC/FTC/TAF and Placebo to DOR/ISL |
Primary outcome
Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥50 Copies/mL at Week 48
Time frame: Week 48
HIV-1 RNA levels in blood samples taken at each visit were measured with a reliable lower limit of quantification of <50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Percentage of Participants Who Experience Adverse Events (AEs) Through Week 48
Time frame: Up to Week 48
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE is reported.
Percentage of Participants Who Discontinue Study Intervention Due to AEs Through Week 48
Time frame: Up to Week 48
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE is reported.
16 secondary outcomes
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
Time frame: Week 48
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Time frame: Week 48
Change From Baseline in Cluster of Differentiation 4-positive (CD4+) T-cell Count at Week 48
Time frame: Baseline at Day 1 and Week 48
Percentage of Participants With Treatment-Emergent, Resistance-associated Substitutions at Week 48
Time frame: Up to Week 48
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 96
Time frame: Week 96
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96
Time frame: Week 96
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
Time frame: Week 96
Change From Baseline in CD4+ T-cell Count at Week 96
Time frame: Baseline at Day 1 and Week 96
Number of Participants With Viral Drug Resistance Mutations at Week 96
Time frame: Week 96
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 144
Time frame: Week 144
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 144
Time frame: Week 144
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 144
Time frame: Week 144
Change From Baseline in CD4+ T-cell Count at Week 144
Time frame: Baseline at Day 1 and Week 144
Number of Participants With Viral Drug Resistance Mutations at Week 144
Time frame: Week 144
Percentage of Participants Who Experience AEs Through Week 144
Time frame: Up to Week 144
Percentage of Participants Who Discontinue Study Intervention Due to AEs Through Week 144
Time frame: Up to Week 144
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42213454Diamond TL, Grandhi A, Fuszard M, Xu Y, Nwoke U, Zhang Y, Klopfer SO, Eves K, Benner J, Li M, Greaves W, Lahoulou R, Kim J, Fox MC, Asante-Appiah E. Switching to Daily Doravirine/Islatravir (100/0.25 mg) Maintains Viral Suppression Through Week 48 Despite Baseline Non-Nucleoside Reverse Transcriptase Inhibitor Resistance-Associated Mutations or M184I/V in Proviral DNA. J Infect Dis. 2026 May 29:jiag257. doi: 10.1093/infdis/jiag257. Online ahead of print.
- Derived from this study: PubMed 41654375Colson AE, Mills AM, Ramgopal MN, Bettacchi C, Osiyemi OO, Hinestrosa F, Crofoot G, Katner HP, Gatanaga H, Johnson M, Diamond TL, Barninger E, Eves K, Su FH, Xu Y, Klopfer SO, Stamm LM, Fox MC, Lahoulou R. Switch to fixed-dose doravirine (100 mg) and islatravir (0.25 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, multicentre, randomised, controlled, double-blind, non-inferiority trial. Lancet. 2026 Feb 7;407(10528):611-621. doi: 10.1016/S0140-6736(25)01948-8.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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HIV-1-infection
Active, not recruitingPhase 2/3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)
HIV-1-infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
49 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DOR/ISL and BIC/FTC/TAF in people with HIV-1 Infection, run by Merck Sharp & Dohme LLC at 49 sites in 6 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 3 inclusion and 9 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 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, United Kingdom, Australia, Chile, Israel and 1 more country. 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 18 Nov 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 48 (time frame: Week 48). The study lists 3 primary outcomes in all. 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 NCT05630755, 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 18 Nov 2025.