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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1439-018 | Other Identifier | MSD Protocol Number | |
| 2014-001127-69 | EudraCT Number |
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To establish a new treatment option for treatment-naïve participants with HIV-1, the efficacy and safety of doravirine will be determined relative to a protease inhibitor (PI). Participants will receive double-blind treatment during the 96-week Base Study. Eligible participants in either of the Base Study groups will continue to receive the doravirine-containing regimen open label for an additional 96 weeks in the Study Extension 1. Eligible participants who are deriving benefit will continue in Study Extension 2 to receive the doravirine-containing regimen open label until doravirine becomes locally available or for an additional 96 weeks, whichever comes first. The primary hypothesis is that doravirine 100 mg once a day (q.d.) is non-inferior to darunavir/ritonavir (800 mg/100 mg) q.d., each in combination with TRUVADA™ or EPZICOM™/KIVEXA™, as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48. If non-inferiority is established, then the superiority of doravirine 100 mg q.d. compared to darunavir/ ritonavir (800 mg/100 mg) q.d. will be assessed.
Participants in Australia, Russia, and South Africa who are deriving benefit from MK-1439A are also eligible to continue receiving study drug during Study Extension 3, which will last for 2 years or until drug is available locally, whichever comes first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doravirine 100 mg | Experimental | Double-blind Doravirine 100 mg administered orally (p.o.) once daily (q.d.) + investigator selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o. q.d. for 96 weeks in the Base Study. Eligible participants may continue in Study Extension 1 with open-label Doravirine 100 mg administered p.o. q.d. + investigator selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o., q.d. for an additional 96 weeks. Eligible participants may continue to receive the Doravirine regimen in Study Extension 2 until Doravirine becomes locally available, or for an additional 96 weeks, whichever comes first. Eligible participants may continue to receive the Doravirine regimen in Study Extension 3 until Doravirine becomes locally available, or for an additional 96 weeks, whichever comes first. |
|
| Darunavir 800 mg and Ritonavir 100 mg | Active Comparator | Double-blind Darunavir 800 mg and Ritonavir 100 mg administered p.o. q.d. + investigator selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o. q.d. for 96 weeks. Eligible participants may continue in Study Extension 1 with open-label Doravirine 100 mg administered p.o. q.d. + investigator selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o. q.d. for an additional 96 weeks. Eligible participants may continue to receive the Doravirine regimen in Study Extension 2 until Doravirine becomes locally available, or for an additional 96 weeks, whichever comes first. Eligible participants may continue to receive the Doravirine regimen in Study Extension 3 until Doravirine becomes locally available, or for an additional 96 weeks, whichever comes first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doravirine | Drug | Doravirine 100 mg tablet administered p.o. q.d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 48 | The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 96 | The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL at Week 96 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42281892 | Derived | Molina JM, Orkin C, Paredes R, Xu ZJ, Su FH, Asante-Appiah E, Plank RM, Lahoulou R. Analysis of Viral Blips Through Week 192 of the DRIVE-FORWARD and DRIVE-AHEAD Phase 3 Studies of Doravirine-Based Regimens in Adults Living With Previously Untreated HIV-1. Open Forum Infect Dis. 2026 Jun 10;13(6):ofag258. doi: 10.1093/ofid/ofag258. eCollection 2026 Jun. | |
| 41280318 |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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A total of 1027 participants were screened and 769 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Doravirine 100 mg | Double-blind Doravirine 100 mg administered orally (p.o.) once daily (q.d.) + investigator-selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o. q.d. for 96 weeks in the Base Study. Eligible participants continued in Study Extension 1 with open-label Doravirine 100 mg administered p.o. q.d. + investigator-selected TRUVADA™ or EPZICOM™/ KIVEXA™ administered p.o. q.d. for an additional 96 weeks. Eligible participants continued to receive the Doravirine regimen in Study Extension 2 for an additional 96 weeks, and in Study Extension 3 for an additional 96 weeks. |
| FG001 | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | Double-blind Darunavir 800 mg and Ritonavir 100 mg administered p.o. q.d. + investigator-selected TRUVADA™ or EPZICOM™/ KIVEXA™ administered p.o. q.d. for 96 weeks in the Base Study. Eligible participants continued in Study Extension 1 with open-label Doravirine 100 mg administered p.o. q.d. + investigator-selected TRUVADA™ or EPZICOM™/ KIVEXA™ administered p.o. q.d. for an additional 96 weeks. Eligible participants continued to receive the Doravirine regimen in Study Extension 2 for an additional 96 weeks, and in Study Extension 3 for an additional 96 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Base Study: 96 Weeks |
|
| ||||||||||||||||||||||||
| Study Extension 1: Week 96 to Week 192 |
| |||||||||||||||||||||||||
| Study Extension 2: Week 192 to Week 288 |
| |||||||||||||||||||||||||
| Study Extension 3: Week 288 to Week 384 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Doravirine 100 mg | Double-blind Doravirine 100 mg administered p.o. q.d. + investigator-selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o. q.d. for 96 weeks in the Base Study. |
| BG001 | Daurunavir 800 mg + Ritonavir 100 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 48 | The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason. | All randomized participants who received at least 1 dose of study drug | Posted | Number | Percentage of participants | Week 48 |
|
Up to Week 386
The analysis population for All-Cause Mortality included all randomized participants. The analysis population for Serious and Other Adverse Events included all participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Doravirine 100 mg | Double-blind Doravirine 100 mg administered p.o. q.d. + investigator-selected TRUVADA™ or EPZICOM™/KIVEXA™ administered p.o. q.d. for 96 weeks in the Base Study. Eligible participants continued in Study Extension 1 with open-label Doravirine 100 mg administered p.o. q.d. + investigator-selected TRUVADA™ or EPZICOM™/ KIVEXA™ administered p.o. q.d. for an additional 96 weeks. Eligible participants continued to receive the Doravirine regimen in Study Extension 2 for an additional 96 weeks, and in Study Extension 3 for an additional 96 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
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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 23, 2022 | Feb 22, 2024 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C000592662 | doravirine |
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 |
Not provided
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| Darunavir | Drug | Darunavir 800 mg tablet administered p.o. q.d. |
|
| Ritonavir | Drug | Ritonavir 100 mg tablet administered p.o. q.d. |
|
| TRUVADA™ or EPZICOM™/KIVEXA™ | Drug | The investigator selects either TRUVADA™, a tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate p.o. q.d. or EPZICOM™/KIVEXA™, a tablet containing 600 mg abacavir sulfate and 300 mg lamivudine, p.o. q.d. |
|
| Week 96 |
| Change From Baseline in Mean CD4+ T-cell Count at Week 48 | CD4+ T-cell counts were quantified by a central laboratory using a commercially available assay. | Baseline and Week 48 |
| Change From Baseline in Mean CD4+ T-cell Count at Week 96 | CD4+ T-cell counts were quantified by a central laboratory using a commercially available assay. | Baseline and Week 96 |
| Mean Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 48 | Serum LDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The Last Observation Carry Forward (LOCF) approach was applied for missing data or data collected after modifying lipid-lowering therapy. | Baseline and Week 48 |
| Mean Change From Baseline in Fasting Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 48 | Serum non-HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. | Baseline and Week 48 |
| Mean Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 48 | Serum HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. | Baseline and Week 48 |
| Mean Change From Baseline in Fasting Total Cholesterol at Week 48 | Serum total cholesterol was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. | Baseline and Week 48 |
| Mean Change From Baseline in Fasting Triglyceride at Week 48 | Serum triglyceride was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. | Baseline and Week 48 |
| Percentage of Participants With Any Adverse Event | An adverse event (AE) is defined as any untoward medical occurrence in a study participant and which does not necessarily have to have a causal relationship to treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the study treatment or protocol-specified procedure, whether or not considered related to study treatment or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study treatment is also an AE. The percentage of participants with any AE was assessed. | Up to 98 weeks |
| Percentage of Participants With Any Serious Adverse Event | A serious adverse event is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants with any SAE was assessed. | Up to 98 weeks |
| Percentage of Participants With Any Drug-related Adverse Event | The investigator was to determine if an AE had a reasonable possibility of a relationship to the study drug. The percentage of participants with any drug-related AE was assessed. | Up to 98 weeks |
| Percentage of Participants With Any Drug-related Serious Adverse Event | The percentage of participants with any drug-related SAE was assessed. | Up to 98 weeks |
| Percentage of Participants Who Discontinued Study Treatment Due to an Adverse Event | The percentage of participants who discontinued study treatment due to an AE was assessed. | Up to 96 weeks |
| Percentage of Participants Achieving Plasma HIV-1 RNA <40 Copies/mL at Week 48 | The percentage of participants in each arm achieving HIV-1 RNA levels <40 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason. | Week 48 |
| Percentage of Participants Achieving Plasma HIV-1 RNA <40 Copies/mL at Week 96 | The percentage of participants in each arm achieving HIV-1 RNA levels <40 copies/mL at Week 96 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason. | Week 96 |
| Orkin C, Koethe JR, Kumar PN, Sklar P, Xu ZJ, Plank RM, Greaves W, Lahoulou R. Factors Associated With Weight Change After Continuing or Switching to a Doravirine-based Regimen. Open Forum Infect Dis. 2025 Nov 20;12(11):ofaf639. doi: 10.1093/ofid/ofaf639. eCollection 2025 Nov. |
| 41081774 | Derived | Hsue PY, Behrens GMN, Xu ZJ, Zhao Y, Cmar J, Lahoulou R, Campo RE, Plank RM. Cardiovascular Risk Assessment Using the Atherosclerotic Cardiovascular Disease Risk Score Model after Continuing or Switching to a Doravirine-Based HIV Treatment Regimen. J Acquir Immune Defic Syndr. 2026 Feb 1;101(2):208-213. doi: 10.1097/QAI.0000000000003778. |
| 40672760 | Derived | Walmsley SL, Kumar PN, Orkin C, Thompson M, Squires K, Xu ZJ, Greaves W, Plank RM, Whiteside Y, Lahoulou R. Efficacy and Safety of Doravirine-based Regimens by Sex and Race: Long-term Results From Three Phase 3 Clinical Trials. Open Forum Infect Dis. 2025 Jul 16;12(7):ofaf356. doi: 10.1093/ofid/ofaf356. eCollection 2025 Jul. |
| 39748155 | Derived | Moyle G, Meng F, Wan H, Sklar P, Plank RM, Lahoulou R. Brief Report: Resolution of Neuropsychiatric Adverse Events After Switching to a Doravirine-Based Regimen in the Open-Label Extensions of the DRIVE-AHEAD and DRIVE-FORWARD Trials. J Acquir Immune Defic Syndr. 2025 May 1;99(1):81-86. doi: 10.1097/QAI.0000000000003599. |
| 38141637 | Derived | Orkin C, Molina JM, Cahn P, Lombaard J, Supparatpinyo K, Kumar S, Campbell H, Wan H, Teal V, Jin Xu Z, Asante-Appiah E, Sklar P, Teppler H, Lahoulou R; DRIVE-FORWARD and DRIVE-AHEAD collaborators. Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials. Lancet HIV. 2024 Feb;11(2):e75-e85. doi: 10.1016/S2352-3018(23)00258-8. Epub 2023 Dec 20. |
| 31740348 | Derived | Molina JM, Squires K, Sax PE, Cahn P, Lombaard J, DeJesus E, Lai MT, Rodgers A, Lupinacci L, Kumar S, Sklar P, Hanna GJ, Hwang C, Martin EA; DRIVE-FORWARD trial group. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomised, double-blind, non-inferiority, phase 3 trial. Lancet HIV. 2020 Jan;7(1):e16-e26. doi: 10.1016/S2352-3018(19)30336-4. Epub 2019 Nov 15. |
| 31121015 | Derived | Orkin C, Molina JM, Lombaard J, DeJesus E, Rodgers A, Kumar S, Martin E, Hanna G, Hwang C. Once-daily Doravirine in Human Immunodeficiency Virus Type 1-Infected, Antiretroviral-naive Adults: An Integrated Efficacy Analysis. Clin Infect Dis. 2020 Mar 17;70(7):1344-1352. doi: 10.1093/cid/ciz424. |
| 31121013 | Derived | Thompson M, Orkin C, Molina JM, Sax P, Cahn P, Squires K, Xu X, Rodgers A, Kumar S, Teppler H, Martin E, Hanna G, Hwang C. Once-daily Doravirine for Initial Treatment of Adults Living With Human Immunodeficiency Virus-1: An Integrated Safety Analysis. Clin Infect Dis. 2020 Mar 17;70(7):1336-1343. doi: 10.1093/cid/ciz423. |
| 29592840 | Derived | Molina JM, Squires K, Sax PE, Cahn P, Lombaard J, DeJesus E, Lai MT, Xu X, Rodgers A, Lupinacci L, Kumar S, Sklar P, Nguyen BY, Hanna GJ, Hwang C; DRIVE-FORWARD Study Group. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial. Lancet HIV. 2018 May;5(5):e211-e220. doi: 10.1016/S2352-3018(18)30021-3. Epub 2018 Mar 25. |
| Plain Language Summary | View source |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Noncompliance with drug |
|
| Physician Decision |
|
| Pregnancy |
|
| Randomized not treated |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
Double-blind Darunavir 800 mg and Ritonavir 100 mg administered p.o. q.d. + investigator-selected TRUVADA™ or EPZICOM™/ KIVEXA™ administered p.o. q.d. for 96 weeks in the Base Study.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Mean Cluster of Differentiation 4 (CD4+) T-cell Count | CD4+ T-cell count was quantified by a central laboratory using a commercially available assay. | Participants with baseline data | Mean | Standard Deviation | Cells/mm^3 |
|
| Plasma HIV-1 RNA | Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. | Participants with baseline data | Median | Full Range | Copies/mL |
|
| Daurunavir 800 mg + Ritonavir 100 mg |
Double-blind Darunavir 800 mg and Ritonavir 100 mg administered p.o. q.d. + investigator-selected TRUVADA™ or EPZICOM™/ KIVEXA™ administered p.o. q.d. for 96 weeks in the Base Study. |
|
|
|
| Secondary | Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 96 | The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL at Week 96 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason. | All randomized participants who received at least 1 dose of study drug and had data for the outcome measure. Participants with missing HIV-1 RNA due to an Abbott RealTime manufacturing agent recall were excluded from the analysis. | Posted | Number | Percentage of participants | Week 96 |
|
|
|
|
| Secondary | Change From Baseline in Mean CD4+ T-cell Count at Week 48 | CD4+ T-cell counts were quantified by a central laboratory using a commercially available assay. | All randomized participants who received at least 1 dose of study drug and had data for the outcome measure. Baseline values were carried forward for participants who discontinued therapy due to lack of efficacy. | Posted | Mean | 95% Confidence Interval | Cells/mm^3 | Baseline and Week 48 |
|
|
|
|
| Secondary | Change From Baseline in Mean CD4+ T-cell Count at Week 96 | CD4+ T-cell counts were quantified by a central laboratory using a commercially available assay. | All randomized participants who received at least 1 dose of study drug and had data for the outcome measure. Baseline values were carried forward for participants who discontinued therapy due to lack of efficacy. | Posted | Mean | 95% Confidence Interval | Cells/mm^3 | Baseline and Week 96 |
|
|
|
|
| Secondary | Mean Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 48 | Serum LDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The Last Observation Carry Forward (LOCF) approach was applied for missing data or data collected after modifying lipid-lowering therapy. | All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 48 |
|
|
|
|
| Secondary | Mean Change From Baseline in Fasting Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 48 | Serum non-HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. | All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 48 |
|
|
|
|
| Secondary | Mean Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 48 | Serum HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. | All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 48 |
|
|
|
| Secondary | Mean Change From Baseline in Fasting Total Cholesterol at Week 48 | Serum total cholesterol was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. | All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 48 |
|
|
|
| Secondary | Mean Change From Baseline in Fasting Triglyceride at Week 48 | Serum triglyceride was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy. | All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 48 |
|
|
|
| Secondary | Percentage of Participants With Any Adverse Event | An adverse event (AE) is defined as any untoward medical occurrence in a study participant and which does not necessarily have to have a causal relationship to treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the study treatment or protocol-specified procedure, whether or not considered related to study treatment or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study treatment is also an AE. The percentage of participants with any AE was assessed. | All randomized participants who received at least 1 dose of study drug | Posted | Number | Percentage of participants | Up to 98 weeks |
|
|
|
| Secondary | Percentage of Participants With Any Serious Adverse Event | A serious adverse event is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants with any SAE was assessed. | All randomized participants who received at least 1 dose of study drug | Posted | Number | Percentage of participants | Up to 98 weeks |
|
|
|
| Secondary | Percentage of Participants With Any Drug-related Adverse Event | The investigator was to determine if an AE had a reasonable possibility of a relationship to the study drug. The percentage of participants with any drug-related AE was assessed. | All randomized participants who received at least 1 dose of study drug | Posted | Number | Percentage of participants | Up to 98 weeks |
|
|
|
| Secondary | Percentage of Participants With Any Drug-related Serious Adverse Event | The percentage of participants with any drug-related SAE was assessed. | All randomized participants who received at least 1 dose of study drug | Posted | Number | Percentage of participants | Up to 98 weeks |
|
|
|
| Secondary | Percentage of Participants Who Discontinued Study Treatment Due to an Adverse Event | The percentage of participants who discontinued study treatment due to an AE was assessed. | All randomized participants who received at least 1 dose of study drug | Posted | Number | Percentage of participants | Up to 96 weeks |
|
|
|
| Secondary | Percentage of Participants Achieving Plasma HIV-1 RNA <40 Copies/mL at Week 48 | The percentage of participants in each arm achieving HIV-1 RNA levels <40 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason. | All randomized participants who received at least 1 dose of study drug | Posted | Number | Percentage of participants | Week 48 |
|
|
|
|
| Secondary | Percentage of Participants Achieving Plasma HIV-1 RNA <40 Copies/mL at Week 96 | The percentage of participants in each arm achieving HIV-1 RNA levels <40 copies/mL at Week 96 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) "snapshot" approach and all missing data were considered treatment failures, regardless of the reason. | All randomized participants who received at least 1 dose of study drug and had data for the outcome measure. Participants with missing HIV-1 RNA due to an Abbott RealTime manufacturing agent recall were excluded from the analysis. | Posted | Number | Percentage of participants | Week 96 |
|
|
|
|
| 3 |
| 385 |
| 45 |
| 383 |
| 264 |
| 383 |
| EG001 | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | Double-blind Darunavir 800 mg and Ritonavir 100 mg administered p.o. q.d. + investigator-selected TRUVADA™ or EPZICOM™/ KIVEXA™ administered p.o. q.d. for 96 weeks in the Base Study. Eligible participants continued in Study Extension 1 with open-label Doravirine 100 mg administered p.o. q.d. + investigator-selected TRUVADA™ or EPZICOM™/ KIVEXA™ administered p.o. q.d. for an additional 96 weeks. Eligible participants continued to receive the Doravirine regimen in Study Extension 2 for an additional 96 weeks, and in Study Extension 3 for an additional 96 weeks. | 3 | 384 | 49 | 383 | 247 | 383 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Anal skin tags | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pancreatitis necrotising | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Acute hepatitis C | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Cellulitis staphylococcal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Chronic hepatitis C | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Fournier's gangrene | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Gastroenteritis shigella | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Herpes oesophagitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Keratouveitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Meningitis tuberculous | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Neurosyphilis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Orchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Perirectal abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Pilonidal disease | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Rectal abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Scrotal abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Tuberculosis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Tuberculosis of central nervous system | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Exposure to toxic agent | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Rectal injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Bone lesion | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Anal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Angiosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Benign salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Bell's palsy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Osmotic demyelination syndrome | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Post abortion haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 26.0 | Systematic Assessment |
|
| Device dislocation | Product Issues | MedDRA 26.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Drug dependence | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Schizoaffective disorder depressive type | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Substance-induced mood disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Drug abuser | Social circumstances | MedDRA 26.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Femoral artery aneurysm | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Syphilis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|