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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8591A-052 | Other Identifier | MSD | |
| 2022-502079-49-00 | Registry Identifier | EU CT | |
| jRCT2051230003 | Registry Identifier | jRCT | |
| U1111-1283-0949 | Registry Identifier | UTN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DOR/ISL | Drug | DOR/ISL 100 mg/0.25 mg oral tablets once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Up to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 48 |
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The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pueblo Family Physicians ( Site 1425) | Phoenix | Arizona | 85015 | United States | ||
| Pacific Oaks Medical Group ( Site 1400) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42213454 | Derived | 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. | |
| 41654375 |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | DOR/ISL and Placebo to BIC/FTC/TAF | Participants will receive doravirine/islatravir (DOR/ISL) 100 mg/0.25 mg and Placebo to bictegravir/emtricitabine/tenofovir alafenamide (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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2024 |
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| BIC/FTC/TAF | Drug | BIC/FTC/TAF 50 mg/200 mg/25 mg oral tablets once daily |
|
|
| Placebo to BIC/FTC/TAF | Drug | 0 mg oral tablets once daily |
|
| Placebo to DOR/ISL | Drug | 0 mg oral tablets once daily |
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to Week 144 |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Ruane Clinical Research Group, Inc ( Site 1414) | Los Angeles | California | 90036 | United States |
| Mills Clinical Research ( Site 1433) | Los Angeles | California | 90069 | United States |
| Whitman-Walker Institute ( Site 1431) | Washington D.C. | District of Columbia | 20005 | United States |
| Therafirst Medical Center ( Site 1402) | Fort Lauderdale | Florida | 33308 | United States |
| Midway Immunology and Research Center ( Site 1401) | Ft. Pierce | Florida | 34982 | United States |
| AHF The Kinder Medical Group ( Site 1426) | Miami | Florida | 33133 | United States |
| Orlando Immunology Center ( Site 1407) | Orlando | Florida | 32803 | United States |
| Triple O Research Institute, P.A ( Site 1417) | West Palm Beach | Florida | 33407 | United States |
| Infectious Disease Specialists of Atlanta ( Site 1403) | Decatur | Georgia | 30033 | United States |
| Mercer University, Department of Internal Medicine ( Site 1411) | Macon | Georgia | 31201 | United States |
| AccessHealth MA ( Site 1419) | Boston | Massachusetts | 02129 | United States |
| Be Well Medical Center ( Site 1408) | Berkley | Michigan | 48072 | United States |
| KC CARE Health Center-Clinical Trials ( Site 1422) | Kansas City | Missouri | 64111 | United States |
| Las Vegas Research Center ( Site 1436) | Las Vegas | Nevada | 89106 | United States |
| Regional Center for Infectious Disease Research ( Site 1435) | Greensboro | North Carolina | 27401 | United States |
| Central Texas Clinical Research ( Site 1413) | Austin | Texas | 78705 | United States |
| St Hope Foundation ( Site 1410) | Bellaire | Texas | 77401 | United States |
| Prism Health North Texas, Oak Cliff Health Center ( Site 1409) | Dallas | Texas | 75205 | United States |
| North Texas Infectious Diseases Consultants, P.A ( Site 1404) | Dallas | Texas | 75246 | United States |
| Texas Centers for Infectious Disease Associates ( Site 1406) | Fort Worth | Texas | 76104 | United States |
| The Crofoot Research Center ( Site 1424) | Houston | Texas | 77098 | United States |
| DCOL Center for Clinical Research ( Site 1415) | Longview | Texas | 75605 | United States |
| Holdsworth House Medical Practice ( Site 6200) | Darlinghurst | New South Wales | 2010 | Australia |
| St Vincent's Hospital-IBAC ( Site 6203) | Sydney | New South Wales | 2010 | Australia |
| Holdsworth House Medical Practice - Brisbane ( Site 6201) | Brisbane | Queensland | 4006 | Australia |
| Royal Brisbane and Women's Hospital-Infectious Diseases Research ( Site 6204) | Brisbane | Queensland | 4029 | Australia |
| Prahran Market Clinic ( Site 6202) | Melbourne | Victoria | 3181 | Australia |
| Hospital hernan henriquez aravena de temuco-Unidad de Investigación ClÃnica ( Site 2205) | Temuco | Araucania | 4781151 | Chile |
| Clinica Universidad Catolica del Maule ( Site 2204) | Talca | Maule Region | 3465584 | Chile |
| ClÃnica Universidad de Los Andes ( Site 2206) | Santiago | Region M. de Santiago | 7620001 | Chile |
| Universidad de Chile - Hospital ClÃnico Universidad de Chile-Inmunologia Alergia y VIH ( Site 2200) | Santiago | Region M. de Santiago | 8380420 | Chile |
| Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 4801) | Haifa | 3109601 | Israel |
| Hadassah Medical Center-Infecious Disease ( Site 4802) | Jerusalem | 9120 | Israel |
| Sheba Medical Center-HIV unit ( Site 4803) | Ramat Gan | 5262100 | Israel |
| Sourasky Medical Center ( Site 4804) | Tel Aviv | 64239 | Israel |
| National Hospital Organization Nagoya Medical Center ( Site 6603) | Nagoya | Aichi-ken | 460-0001 | Japan |
| Center Hospital of the National Center for Global Health and Medicine ( Site 6601) | Shinjyuku-ku | Tokyo | 162-8655 | Japan |
| National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 66 | Osaka | 540-0006 | Japan |
| Southmead Hospital ( Site 5805) | Bristol | Bristol, City of | BS10 5NB | United Kingdom |
| Queen Elizabeth Hospital Birmingham ( Site 5809) | Birmingham | England | B15 2TH | United Kingdom |
| Royal Liverpool University Hospital ( Site 5812) | Liverpool | England | L7 8XP | United Kingdom |
| Royal London Hospital ( Site 5800) | London | England | E1 1BB | United Kingdom |
| Royal Free Hospital ( Site 5801) | London | England | NW32QG | United Kingdom |
| Guy's & St Thomas' NHS Foundation Trust ( Site 5808) | London | London, City of | SE1 9RT | United Kingdom |
| The Mortimer Market Centre for Sexual Health and HIV Research ( Site 5810) | London | London, City of | WC1E 6JB | United Kingdom |
| University Hospital of Wales ( Site 5803) | Cardiff | Wales | CF14 4XW | United Kingdom |
| Royal Berkshire Hospital ( Site 5813) | Reading | RG1 5AN | United Kingdom |
| Derived |
| Colson 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. |
| Plain Language Summary | View source |
| FG001 | BIC/FTC/TAF and Placebo to DOR/ISL | 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). |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DOR/ISL and Placebo to BIC/FTC/TAF | 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). |
| BG001 | BIC/FTC/TAF and Placebo to DOR/ISL | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis population includes all randomized participants who received ≥1 dose of study intervention. | Posted | Number | Percentage of Participants | Week 48 |
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| Primary | 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. | The analysis population includes all randomized participants who received ≥1 dose of study intervention. | Posted | Number | Percentage of Participants | Up to Week 48 |
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| Primary | 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. | The analysis population includes all randomized participants who received ≥1 dose of study intervention. | Posted | Number | Percentage of Participants | Up to Week 48 |
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| Secondary | 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. | The analysis population includes all randomized participants who received ≥1 dose of study intervention. | Posted | Number | Percentage of Participants | Week 48 |
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| Secondary | 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. | The analysis population includes all randomized participants who received ≥1 dose of study intervention. | Posted | Number | Percentage of Participants | Week 48 |
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| Secondary | 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. | The analysis population includes all randomized participants who received ≥1 dose of study intervention and who had baseline data for CD4+ T-cell count. | Posted | Mean | 95% Confidence Interval | Cells/mm^3 | Baseline at Day 1 and Week 48 |
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| Secondary | 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. | 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. Participants without available assay results were not included. | Posted | Number | Percentage of Participants | Up to Week 48 |
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| Secondary | 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. | Not Posted | Aug 2029 | Week 96 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Aug 2029 | Week 96 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Aug 2029 | Week 96 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Aug 2029 | Baseline at Day 1 and Week 96 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Aug 2029 | Week 96 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Aug 2029 | Week 144 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Aug 2029 | Week 144 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Aug 2029 | Week 144 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Aug 2029 | Baseline at Day 1 and Week 144 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Aug 2029 | Week 144 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Aug 2029 | Up to Week 144 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Aug 2029 | Up to Week 144 | Participants |
Up to 84 weeks
All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DOR/ISL and Placebo to BIC/FTC/TAF | 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). | 0 | 343 | 15 | 342 | 94 | 342 |
| EG001 | BIC/FTC/TAF and Placebo to DOR/ISL | 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). | 0 | 171 | 11 | 171 | 52 | 171 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute hepatitis C | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Tonsil cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intracranial hypotension | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Oct 13, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| C000592662 | doravirine |
| C558823 | islatravir |
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Miettinen and Nurminen method |
Unstratified Miettinen and Nurminen method was used |
| 0.192 |
| Risk Difference (RD) |
| 0.88 |
| 2-Sided |
| 95 |
| -1.86 |
| 2.90 |
| Superiority |
The estimated difference was calculated using the unstratified Miettinen and Nurminen method. |
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
| OG001 | BIC/FTC/TAF and Placebo to DOR/ISL | 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). |
|
|