A Phase 3 interventional study of DOR/ISL and ART in HIV Infection, sponsored by Merck Sharp & Dohme LLC. Completed at 78 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.
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Exclusion Criteria:
Participants who were previously treated with continuous baseline antiretroviral therapy (ART) will receive DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.
Drug: DOR/ISL
Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Drug: DOR/ISL · Drug: ART
A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily
Also known as: MK-8591A
Baseline ART regimen will be administered as per approved label. ART medication will not be provided by the Sponsor; participants will provide their own ART medications. Allowed drug classes include nucleoside analog reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transferase inhibitors (InSTIs), fusion inhibitors, chemokine receptor 5 (CCR5) antagonists, post-attachment inhibitor, and pharmacokinetic (PK) boosters.
Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) ≥50 Copies/mL at Week 48
HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 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.
Time frame: Week 48
Percentage of Participants With One or More Adverse Events (AEs) 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 was reported.
Time frame: Up to ~48 Weeks
Percentage of Participants Who Discontinued Study Intervention Due to an AE 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 was reported.
Time frame: Up to ~48 Weeks
Percentage of Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 48
HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA \<40 copies/mL or \<50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Time frame: Week 48
Group 2 (Switch-Over): Percentage of Participants With HIV-1 RNA ≥50 Copies/mL, <40 Copies/mL or <50 Copies/mL at Week 96
HIV-1 RNA levels in blood samples taken at each visit was measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL, \<40 copies/mL, or \<50 copies/mL at Week 96 is reported for Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96. Per protocol, the percentage of participants with HIV-1 RNA ≥50 copies/mL, \<40 copies/mL, or \<50 copies/mL at Week 96 for Group 1 participants is a separate outcome measure and is presented later in the record.
Time frame: Week 96
Group 1: Percentage of Participants With HIV-1 RNA ≥50 Copies/mL, <40 Copies/mL or <50 Copies/mL at Week 96
HIV-1 RNA levels in blood samples taken at each visit was measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL, \<40 copies/mL, or \<50 copies/mL at Week 96 is reported for Group 1 participants. Per protocol, the percentage of participants with HIV-1 RNA ≥50 copies/mL, \<40 copies/mL, or \<50 copies/mL at Week 96 for Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96 is a separate outcome measure and is presented earlier in the record.
Time frame: Week 96
Percentage Change From Baseline in 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 percentage change from baseline to Week 48 is presented.
Time frame: Baseline and Week 48
Group 1: Percentage Change From Baseline in CD4+ T-cell Count at Week 96
Plasma CD4+ T-Cell Count was measured in cells/mm\^3 for baseline and 96 weeks. Baseline measurements were defined as the Day 1 value of each participant. The mean percent change from baseline to Week 96 in CD4+ T-cell count is reported for Group 1 participants. Per protocol, the mean percentage change from baseline in CD4+ T-cell count at Week 96 for Group 2 participants was not planned or conducted.
Time frame: Baseline and Week 96
Group 1 & Group 2 (Switch-Over): Percentage Change From Week 48 in CD4+ T-cell Count at Week 96
Plasma CD4+ T-Cell Count was measured in cells/mm\^3 for Week 48 and Week 96. The mean percent change from Week 48 to Week 96 is reported for Group 1 and Group 2 participants who delayed switch over from baseline ART to DOR/ISL Week 48 to Week 96.
Time frame: Week 48 and Week 96
Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 48
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The percentage of participants who demonstrated drug resistance at Week 48 is presented.
Time frame: Week 48
Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96
Viral drug resistance was defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The percentage of participants who demonstrate drug resistance at Week 96 is presented for Group 1 and Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96. Per protocol, the percentage of participants with evidence of viral drug resistance-associated substitutions from week 0 to week 48 for Group 1 and Group 2 participants is a separate outcome measure and is presented earlier in the record.
Time frame: Week 96
Change From Baseline to Week 24 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens)
Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on PI-containing regimens (including PI- and InSTI-containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens)
Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on InSTI-based regimens (non-PI containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens
Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on all other non-PI- and non-InSTI containing regimens, excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.
Time frame: Baseline and Week 24
Change From Baseline to Week 48 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens)
Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on PI-containing regimens (including PI- and InSTI-containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.
Time frame: Baseline and Week 48
Change From Baseline to Week 48 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens)
Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on InSTI-based regimens (non-PI containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.
Time frame: Baseline and Week 48
Change From Baseline to Week 48 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens
Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on all other non-PI- and non-InSTI containing regimens, excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.
Time frame: Baseline and Week 48
Change From Baseline in Body Weight at Week 48 for InSTI-based Regimens (Non-PI-containing Regimens)
Baseline measurements were defined as the Day 1 value of each participant. The change from baseline in body weight to Week 48 is presented for participants who received InSTI- based regimens.
Time frame: Baseline and Week 48
Group 1: Percentage of Participants With One or More AEs up to Week 96
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 up to Week 96 is reported for Group 1 participants. Per protocol, the percentage of participants with one or more AEs for Group 2 participants is a separate outcome measure and is presented later in the record.
Time frame: Up to ~96 Weeks
Group 1: Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 96
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 up to Week 96 is reported for Group 1 participants. Per protocol, the percentage of participants who discontinued study intervention for Group 2 participants is a separate outcome measure and is presented later in the record.
Time frame: Up to ~96 Weeks
Group 1 & Group 2 (Switch-Over): Percentage of Participants With One or More AEs From Week 48 to Week 96
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 from Week 48 up to Week 96 is reported for Group 1 participants and Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96.
Time frame: Weeks 48-96 (up to ~48 weeks)
Group 1 & Group 2 (Switch-Over): Percentage of Participants Who Discontinued Study Intervention Due to an AE From Week 48 to Week 96
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 from Week 48 up to Week 96 is reported for Group 1 participants and Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96.
Time frame: Weeks 48-96 (up to ~48 weeks)
| Milestone | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Started | 336 | 336 |
| Group 1 participants who received dor/isl from 0-48 weeks | 336 | 0 |
| Group 1 participants who received dor/isl from 48-96 weeks | 322 | 0 |
| Group 2 participants who received baseline art from weeks 0-48 | 0 | 336 |
| Group 2 participants who delayed switch over to dor/isl weeks 48-96 | 0 | 326 |
| Completed | 279 | 299 |
| Not completed | 57 | 37 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Lost to follow-up | 4 | 5 |
| Withdrew: Physician decision | 10 | 6 |
| Withdrew: Withdrawal by subject | 35 | 17 |
| Withdrew: Not reported | 7 | 8 |
HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 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 | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) ≥50 Copies/mL at Week 48 | 0.0 | 1.5 |
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 was reported.
| Percentage of Participants | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Percentage of Participants With One or More Adverse Events (AEs) up to Week 48 | 80.1 | 70.2 |
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 was reported.
| Percentage of Participants | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48 | 2.1 | 0.3 |
HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA \<40 copies/mL or \<50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
| Percentage of Participants | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| HIV-1 RNA <40 copies/mL | 94.6 | 94.3 |
| HIV-1 RNA <50 copies/mL | 95.2 | 94.3 |
HIV-1 RNA levels in blood samples taken at each visit was measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL, \<40 copies/mL, or \<50 copies/mL at Week 96 is reported for Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96. Per protocol, the percentage of participants with HIV-1 RNA ≥50 copies/mL, \<40 copies/mL, or \<50 copies/mL at Week 96 for Group 1 participants is a separate outcome measure and is presented later in the record.
| Percentage of Participants | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| HIV-1 RNA ≥50 copies/mL | — | 0.9 (0.2 to 2.7) |
| HIV-1 RNA <50 copies/mL | — | 89.6 (85.7 to 92.7) |
| HIV-1 RNA <40 copies/mL | — | 89.6 (85.7 to 92.7) |
HIV-1 RNA levels in blood samples taken at each visit was measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL, \<40 copies/mL, or \<50 copies/mL at Week 96 is reported for Group 1 participants. Per protocol, the percentage of participants with HIV-1 RNA ≥50 copies/mL, \<40 copies/mL, or \<50 copies/mL at Week 96 for Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96 is a separate outcome measure and is presented earlier in the record.
| Percentage of Participants | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| HIV-1 RNA ≥50 copies/mL | 1.2 (0.3 to 3.0) | — |
| HIV-1 RNA <40 copies/mL | 86.0 (81.8 to 89.5) | — |
| HIV-1 RNA <50 copies/mL | 85.7 (81.5 to 89.3) | — |
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 percentage change from baseline to Week 48 is presented.
| Percentage Change | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Percentage Change From Baseline in CD4+ T-cell Count at Week 48 | -0.7 (-4.0 to 2.6) | 8.7 (5.4 to 12.0) |
Plasma CD4+ T-Cell Count was measured in cells/mm\^3 for baseline and 96 weeks. Baseline measurements were defined as the Day 1 value of each participant. The mean percent change from baseline to Week 96 in CD4+ T-cell count is reported for Group 1 participants. Per protocol, the mean percentage change from baseline in CD4+ T-cell count at Week 96 for Group 2 participants was not planned or conducted.
| Percentage Change | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Group 1: Percentage Change From Baseline in CD4+ T-cell Count at Week 96 | 4.49 (0.56 to 8.43) | — |
Plasma CD4+ T-Cell Count was measured in cells/mm\^3 for Week 48 and Week 96. The mean percent change from Week 48 to Week 96 is reported for Group 1 and Group 2 participants who delayed switch over from baseline ART to DOR/ISL Week 48 to Week 96.
| Percentage Change | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Group 1 & Group 2 (Switch-Over): Percentage Change From Week 48 in CD4+ T-cell Count at Week 96 | 5.29 (1.99 to 8.58) | 0.16 (-2.96 to 3.29) |
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The percentage of participants who demonstrated drug resistance at Week 48 is presented.
| Percentage of Participants | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 48 | 0.0 | 0.9 |
Viral drug resistance was defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The percentage of participants who demonstrate drug resistance at Week 96 is presented for Group 1 and Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96. Per protocol, the percentage of participants with evidence of viral drug resistance-associated substitutions from week 0 to week 48 for Group 1 and Group 2 participants is a separate outcome measure and is presented earlier in the record.
| Percentage of Participants | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96 | 0.0 | 0.0 |
Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on PI-containing regimens (including PI- and InSTI-containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.
| mg/dL | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Fasting Cholesterol | -12.94 (-23.94 to -1.94) | 6.20 (-2.16 to 14.56) |
| Fasting HDL | -0.97 (-5.94 to 4.00) | 0.76 (-1.80 to 3.32) |
| Fasting LDL Cholesterol | -7.47 (-15.86 to 0.92) | 5.93 (-1.08 to 12.93) |
| Fasting Non-HDL Cholesterol | -11.97 (-21.83 to -2.10) | 5.44 (-2.29 to 13.16) |
| Fasting Triglycerides | -22.69 (-42.92 to -2.46) | -3.16 (-19.81 to 13.49) |
Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on InSTI-based regimens (non-PI containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.
| mg/dL | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Fasting Cholesterol | 2.98 (-2.19 to 8.14) | 8.74 (4.25 to 13.23) |
| Fasting HDL Cholesterol | 0.84 (-1.11 to 2.79) | 0.27 (-1.06 to 1.60) |
| Fasting LDL Cholesterol | 3.21 (-1.49 to 7.92) | 8.50 (4.27 to 12.73) |
| Fasting Non-HDL Cholesterol | 2.14 (-3.39 to 7.67) | 8.47 (4.05 to 12.90) |
| Fasting Triglycerides | -0.97 (-17.98 to 16.04) | -1.56 (-10.80 to 7.69) |
Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on all other non-PI- and non-InSTI containing regimens, excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.
| mg/dL | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Fasting Cholesterol | 7.18 (-0.49 to 14.85) | 7.35 (2.44 to 12.25) |
| Fasting HDL Cholesterol | -3.43 (-6.51 to -0.36) | -0.72 (-3.02 to 1.58) |
| Fasting LDL Cholesterol | 11.33 (5.75 to 16.92) | 7.19 (3.35 to 11.04) |
| Fasting Non-HDL Cholesterol | 11.07 (4.40 to 17.74) | 8.07 (4.10 to 12.04) |
| Fasting Triglycerides | -1.16 (-14.27 to 11.95) | 4.45 (-3.89 to 12.80) |
Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on PI-containing regimens (including PI- and InSTI-containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.
| mg/dL | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Fasting Cholesterol | -15.31 (-28.99 to -1.64) | 1.84 (-5.70 to 9.38) |
| Fasting HDL Cholesterol | -1.45 (-6.01 to 3.11) | -1.08 (-3.91 to 1.75) |
| Fasting LDL Cholesterol | -8.59 (-19.72 to 2.54) | 3.37 (-3.30 to 10.04) |
| Fasting Non-HDL Cholesterol | -13.86 (-25.28 to -2.45) | 2.81 (-4.40 to 10.01) |
| Fasting Triglycerides | -26.90 (-42.31 to -11.48) | 2.28 (-16.39 to 20.95) |
Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on InSTI-based regimens (non-PI containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.
| mg/dL | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Fasting Cholesterol | 2.23 (-2.70 to 7.17) | 4.39 (-0.19 to 8.96) |
| Fasting HDL Cholesterol | 0.23 (-1.61 to 2.08) | 0.13 (-1.24 to 1.51) |
| Fasting LDL Cholesterol | 2.74 (-1.27 to 6.76) | 3.44 (-0.88 to 7.76) |
| Fasting Non-HDL Cholesterol | 2.00 (-3.16 to 7.16) | 4.37 (-0.24 to 8.98) |
| Fasting Triglycerides | -2.29 (-15.02 to 10.44) | 4.44 (-5.60 to 14.48) |
Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on all other non-PI- and non-InSTI containing regimens, excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.
| mg/dL | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Fasting Cholesterol | 5.66 (-1.38 to 12.70) | 4.62 (0.10 to 9.15) |
| Fasting HDL Cholesterol | -3.84 (-6.72 to -0.97) | -1.98 (-4.60 to 0.63) |
| Fasting LDL Cholesterol | 9.27 (4.05 to 14.49) | 7.30 (3.97 to 10.63) |
| Fasting Non-HDL Cholesterol | 9.94 (4.16 to 15.73) | 6.61 (3.13 to 10.08) |
| Fasting Triglycerides | 3.33 (-9.54 to 16.21) | -2.97 (-12.37 to 6.43) |
Baseline measurements were defined as the Day 1 value of each participant. The change from baseline in body weight to Week 48 is presented for participants who received InSTI- based regimens.
| kg | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Change From Baseline in Body Weight at Week 48 for InSTI-based Regimens (Non-PI-containing Regimens) | 0.66 (-0.17 to 1.48) | 0.10 (-0.56 to 0.75) |
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 up to Week 96 is reported for Group 1 participants. Per protocol, the percentage of participants with one or more AEs for Group 2 participants is a separate outcome measure and is presented later in the record.
| Percentage of Participants | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Group 1: Percentage of Participants With One or More AEs up to Week 96 | 92.3 | — |
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 up to Week 96 is reported for Group 1 participants. Per protocol, the percentage of participants who discontinued study intervention for Group 2 participants is a separate outcome measure and is presented later in the record.
| Percentage of Participants | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Group 1: Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 96 | 5.7 | — |
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 from Week 48 up to Week 96 is reported for Group 1 participants and Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96.
| Percentage of Participants | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Group 1 & Group 2 (Switch-Over): Percentage of Participants With One or More AEs From Week 48 to Week 96 | 73.0 | 76.4 |
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 from Week 48 up to Week 96 is reported for Group 1 participants and Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96.
| Percentage of Participants | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) |
|---|---|---|
| Group 1 & Group 2 (Switch-Over): Percentage of Participants Who Discontinued Study Intervention Due to an AE From Week 48 to Week 96 | 3.7 | 2.5 |
Collected over Up to approximately 49 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: DOR/ISL Weeks 0-48 | 0/336 (0%) | 16/336 (4.8%) | 85/336 (25.3%) |
| Group 1: DOR/ISL Weeks 48-End of Trial | 1/322 (0.3%) | 13/322 (4%) | 115/322 (35.7%) |
| Group 2: Baseline ART Weeks 0-48 | 1/336 (0.3%) | 15/336 (4.5%) | 52/336 (15.5%) |
| Group 2: DOR/ISL Weeks 48-End of Trial | 0/326 (0%) | 12/326 (3.7%) | 120/326 (36.8%) |
| Event | Group 1: DOR/ISL Weeks 0-48 | Group 1: DOR/ISL Weeks 48-End of Trial | Group 2: Baseline ART Weeks 0-48 | Group 2: DOR/ISL Weeks 48-End of Trial |
|---|---|---|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 3/336 | 0/322 | 0/336 | 0/326 |
| AppendicitisInfections and infestations | 1/336 | 1/322 | 1/336 | 0/326 |
| MalariaInfections and infestations | 0/336 | 1/322 | 0/336 | 0/326 |
| Ligament ruptureInjury, poisoning and procedural complications | 0/336 | 1/322 | 0/336 | 0/326 |
| Troponin increasedInvestigations | 0/336 | 1/322 | 0/336 | 0/326 |
| ArthritisMusculoskeletal and connective tissue disorders | 0/336 | 1/322 | 0/336 | 0/326 |
| Cervical spinal stenosisMusculoskeletal and connective tissue disorders | 0/336 | 1/322 | 0/336 | 0/326 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 1/336 | 1/322 | 0/336 | 0/326 |
| Pancreatic carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/336 | 1/322 | 0/336 | 0/326 |
| VIth nerve paralysisNervous system disorders | 0/336 | 1/322 | 0/336 | 0/326 |
| Event | Group 1: DOR/ISL Weeks 0-48 | Group 1: DOR/ISL Weeks 48-End of Trial | Group 2: Baseline ART Weeks 0-48 | Group 2: DOR/ISL Weeks 48-End of Trial |
|---|---|---|---|---|
| Lymphocyte count decreasedInvestigations | 0/336 | 65/322 | 0/336 | 44/326 |
| COVID-19Infections and infestations | 18/336 | 42/322 | 15/336 | 57/326 |
| CD4 lymphocytes decreasedInvestigations | 2/336 | 45/322 | 0/336 | 39/326 |
| HeadacheNervous system disorders | 36/336 | 12/322 | 16/336 | 14/326 |
| Accidental overdoseInjury, poisoning and procedural complications | 24/336 | 4/322 | 3/336 | 8/326 |
| OsteopeniaMusculoskeletal and connective tissue disorders | 10/336 | 2/322 | 19/336 | 7/326 |
| Age, Continuous(Years) | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) | Total |
|---|---|---|---|
| Mean | 45.5 ± 11.7 | 45.4 ± 11.7 | 45.5 ± 11.7 |
| Sex: Female, Male(Participants) | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) | Total |
|---|---|---|---|
| Female | 123 | 126 | 249 |
| Male | 213 | 210 | 423 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) | Total |
|---|---|---|---|
| Hispanic or Latino | 67 | 64 | 131 |
| Not Hispanic or Latino | 266 | 270 | 536 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Race (NIH/OMB)(Participants) | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 4 | 8 | 12 |
| Asian | 19 | 19 | 38 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 |
| Black or African American | 88 | 91 | 179 |
| White | 210 | 198 | 408 |
| More than one race | 13 | 16 | 29 |
| Unknown or Not Reported | 2 | 2 | 4 |
| ART Regimen Stratification(Participants) | Group 1: Doravirine/Islatravir (DOR/ISL) | Group 2: Baseline Antiretroviral Therapy (ART) | Total |
|---|---|---|---|
| PI-containing regimens (including PI- and InSTI-containing regimens) | 46 | 46 | 92 |
| InSTI-based regimens (non-PI containing regimens) | 174 | 174 | 348 |
| All other non-PI- and non-InSTI containing regimens | 116 | 116 | 232 |
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