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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1439-007 | Other Identifier | Merck | |
| 2012-001573-93 | EudraCT Number |
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The hypothesis tested in this study is that doravirine (MK-1439) at the final dose selected is superior to efavirenz, each given in combination with TRUVADA®, as measured by the percentage of participants with CNS events by Week 8. If superiority is established at Week 8, the same hypothesis will be tested for Week 24.
Part I - Dose-Ranging. Part I will evaluate the (1) safety and tolerability and (2) efficacy (antiretroviral activity) of 4 doses of doravirine compared with efavirenz, when each is given in combination with TRUVADA® for at least 24 weeks in approximately 200 participants. A single dose of doravirine will be selected for further study after all participants complete the Week 24 visit in Part I. Participants receiving any dose of doravirine in Part I will be switched to the selected doravirine dose and continue in the study for up to 96 weeks, but will not be randomized to Part II.
Part II - Selected Dose. Part II will be initiated after the doravirine dose has been selected as indicated above for Part 1. Approximately 120 additional participants will be randomized in 1:1 ratio to the selected dose of doravirine or efavirenz, each in combination with TRUVADA® for 96 weeks of blinded treatment. Part II will evaluate the safety of the selected dose compared with efavirenz, particularly with regard to central nervous system (CNS) adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doravirine 25 mg | Experimental | Doravirine 25 mg + TRUVADA® Participants in this arm will receive doravirine 25 mg in Part I and the selected doravirine dose (either 25 mg, 50 mg, 100 mg, or 200 mg) in Part II. These participants also receive placebo that matches efavirenz. |
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| Doravirine 50 mg | Experimental | Doravirine 50 mg + TRUVADA® Participants in this arm will receive doravirine 50 mg in Part I and the selected doravirine dose (either 25 mg, 50 mg, 100 mg, or 200 mg) in Part II. These participants also receive placebo that matches efavirenz. |
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| Doravirine 100 mg | Experimental | Doravirine 100 mg + TRUVADA® Participants in this arm will receive doravirine 100 mg in Part I and the selected doravirine dose (either 25 mg, 50 mg, 100 mg, or 200 mg) in Part II. These participants also receive placebo that matches efavirenz. |
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| Doravirine 200 mg | Experimental | Doravirine 200 mg + TRUVADA® Participants in this arm will receive doravirine 200 mg in Part I and the selected doravirine dose (either 25 mg, 50 mg, 100 mg, or 200 mg) in Part II. These participants also receive placebo that matches efavirenz. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doravirine | Drug | Part I: Doravirine 25 mg, 50 mg (25 mg X 2), 100 mg, or 200 mg (100 mg X 2) depending upon randomization, taken orally every morning with or without food for at least 24 weeks. Part II: Selected dose of doravirine depending upon randomization (either 25 mg, 50 mg, 100 mg, or 200 mg) tablet orally every morning with or without food for 96 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With At Least 1 AE in Weeks 0-24: Doravirine (All Doses) vs Efavirenz (Part I) | Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-24. | Up to Week 24 |
| Percentage of Participants Who Discontinued Study Therapy Due to AEs in Weeks 0-24: Doravirine (All Doses) vs Efavirenz (Part I) | Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who discontinued therapy due to an AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Weeks 0-24. | Up to Week 24 |
| Percentage of Participants With At Least 1 AE in Weeks 0-24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was assessed for Weeks 0-24. | Up to Week 24 |
| Percentage of Participants With CNS Events by Week 8: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 48. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined. |
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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 |
|---|---|---|---|
| 31355775 | Derived | Gatell JM, Morales-Ramirez JO, Hagins DP, Thompson M, Arasteh K, Hoffmann C, Raffi F, Osiyemi O, Dretler R, Harvey C, Xu X, Plettenberg A, Smith DE, Portilla J, Rugina S, Kumar S, Frobose C, Wan H, Rodgers A, Hwang C, Teppler H. Doravirine dose selection and 96-week safety and efficacy versus efavirenz in antiretroviral therapy-naive adults with HIV-1 infection in a Phase IIb trial. Antivir Ther. 2019;24(6):425-435. doi: 10.3851/IMP3323. | |
| 31121013 |
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210 participants were randomized to Part I and 132 participants were randomized to Part II.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part I: Doravirine 25 mg | Doravirine 25 mg once daily plus TRUVADA once daily in Part I |
| FG001 | Part I: Doravirine 50 mg | Doravirine 50 mg once daily plus TRUVADA once daily in Part I |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized Participants |
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| Efavirenz | Active Comparator | Efavirenz + TRUVADA® Participants in this arm will receive efavirenz in Part I and in Part II. These participants also receive placebo that matches doravirine. |
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| Efavirenz | Drug | Efavirenz 600 mg tablet orally at bedtime taken without food on an empty stomach for 96 weeks |
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| TRUVADA® | Drug | Open-label TRUVADA® (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablet taken orally with food in the morning for 96 weeks |
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| Placebo for Doravirine | Drug | Placebo tablets matching doravirine |
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| Placebo for Efavirenz | Drug | Placebo tablets matching efavirenz |
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Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had CNS events over 8 weeks of treatment. CNS events were pooled and evaluated as pre-specified by the protocol (depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, hallucination auditory, hallucination visual, completed suicide, suicidal behavior, major depression, depressed mood, depressive symptom, insomnia, disturbance in attention, somnolence, dizziness, or concentration impaired). The percentage of participants in either treatment group with CNS events was assessed over Weeks 0-8. |
| Up to Week 8 |
| Percentage of Participants With CNS Events by Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had CNS events over 24 weeks of treatment. CNS events were pooled and evaluated as pre-specified by the protocol (depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, hallucination auditory, hallucination visual, completed suicide, suicidal behavior, major depression, depressed mood, depressive symptom, insomnia, disturbance in attention, somnolence, dizziness, or concentration impaired). The percentage of participants in either treatment group with CNS events was assessed over Weeks 0-24. | Up to Week 24 |
| Percentage of Participants With Virologic Response (HIV-1 RNA) < 40 Copies/mL) at Week 24: Doravirine (All Doses) vs Efavirenz (Part I) | Assessment of the virologic response to doravirine at all studied doses (25 mg, 50 mg, 100 mg, and 200 mg), compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <40 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification of 40 copies/mL. The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The Non-Completer = Failure (NC=F) approach, in which participants who prematurely discontinued assigned treatment for any reason and were considered as failures thereafter, was used as the primary approach to handle missing data this analysis of efficacy.This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I. | Week 24 |
| Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification of 40 copies/mL. The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined. | Week 24 |
| Week 48 |
| Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 96. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined. | Week 96 |
| Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 24: Doravirine (All Doses) vs Efavirenz (Part I) | Assessment of the virologic response to doravirine at all studied doses (25 mg, 50 mg, 100 mg, and 200 mg), compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay.The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The NC=F approach was used as the primary approach to handle missing data for this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I. | Week 24 |
| Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data for this analysis of efficacy. This secondary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I & Part II combined. | Week 24 |
| Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Evaluation of the antiretroviral activity of doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA for 24 weeks, as measured by the percentage of participants with HIV-1 RNA <200 copies/mL at Week 48. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. This primary outcome was analyzed for RNA <200 copies/mL in Part I & Part II combined. | Week 48 |
| Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 96. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-96. The Non-Completer = Failure (NC=F) approach, in which participants who prematurely discontinued assigned treatment for any reason and were considered as failures thereafter, was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I & Part II combined. | Week 96 |
| Change From Baseline in CD4 T Lymphocyte Cell Count at Week 24: Doravirine (All Doses) vs Efavirenz (Part I) | Evaluation of the change from baseline in the CD4 cell count at Week 24 in participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, and 200 mg), compared with participants receiving efavirenz 600 mg. The Observed Failure (OF) approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for participants who discontinued assigned treatment due to lack of efficacy. | Baseline, Week 24 |
| Change From Baseline in CD4 Cell Count at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the change from baseline in the CD4 cell count at Week 24 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for participants who discontinued assigned treatment due to lack of efficacy. | Baseline, Week 24 |
| Change From Baseline in CD4 Cell Count at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the change from baseline in the CD4 count at Week 48 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for subjects who discontinued assigned treatment due to lack of efficacy. | Baseline, Week 48 |
| Change From Baseline in CD4 Cell Count at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | A secondary endpoint in Part I/II combined was the change from baseline in the CD4 count at Week 96 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for subjects who discontinued assigned treatment due to lack of efficacy. | Baseline, Week 96 |
| Percentage of Participants With At Least 1 AE in Weeks 0-48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | A secondary outcome in Part I/II combined was the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 48 weeks of treatment. The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-48. | Up to Week 48 |
| Percentage of Participants With At Least 1 AE in Weeks 0-96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | A secondary outcome in Part I/II combined was the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 96 weeks of treatment. The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-96. | Up to Week 96 |
| 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. |
| FG002 | Part I: Doravirine 100 mg | Doravirine 100 mg once daily plus TRUVADA once daily in Part I |
| FG003 | Part I: Doravirine 200 mg | Doravirine 200 mg once daily plus TRUVADA once daily in Part I |
| FG004 | Part I: Efavirenz 600 mg | Efavirenz 600 mg once daily plus TRUVADA once daily in Part I |
| FG005 | Part II: Doravirine 100 mg | Doravirine 100 mg once daily plus TRUVADA once daily in Part II |
| FG006 | Part II: Efavirenz 600 mg | Efavirenz 600 mg once daily plus TRUVADA once daily in Part II |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment: Part I |
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| Treatment: Part II |
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All Treated participants randomized to doravirine or efavirenz using an interactive voice response system (IVRS)
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| ID | Title | Description |
|---|---|---|
| BG000 | Doravirine 25 mg: Part I/II Combined | Doravirine 25 mg once daily plus TRUVADA once daily |
| BG001 | Doravirine 50 mg Part I/II Combined | Doravirine 50 mg once daily plus TRUVADA once daily |
| BG002 | Doravirine 100 mg: Part I/II Combined | Doravirine 100 mg once daily plus TRUVADA once daily |
| BG003 | Doravirine 200 mg: Part I/II Combined | Doravirine 200 mg once daily plus TRUVADA once daily |
| BG004 | Efavirenz 600 mg: Part I/II Combined | Efavirenz 600 mg once daily plus TRUVADA once daily |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With At Least 1 AE in Weeks 0-24: Doravirine (All Doses) vs Efavirenz (Part I) | Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-24. | The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in Part I. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 24 |
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| Primary | Percentage of Participants Who Discontinued Study Therapy Due to AEs in Weeks 0-24: Doravirine (All Doses) vs Efavirenz (Part I) | Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who discontinued therapy due to an AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Weeks 0-24. | The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in Part I. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 24 |
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| Primary | Percentage of Participants With At Least 1 AE in Weeks 0-24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was assessed for Weeks 0-24. | The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 24 |
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| Primary | Percentage of Participants With CNS Events by Week 8: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had CNS events over 8 weeks of treatment. CNS events were pooled and evaluated as pre-specified by the protocol (depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, hallucination auditory, hallucination visual, completed suicide, suicidal behavior, major depression, depressed mood, depressive symptom, insomnia, disturbance in attention, somnolence, dizziness, or concentration impaired). The percentage of participants in either treatment group with CNS events was assessed over Weeks 0-8. | The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 8 |
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| Primary | Percentage of Participants With CNS Events by Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had CNS events over 24 weeks of treatment. CNS events were pooled and evaluated as pre-specified by the protocol (depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, hallucination auditory, hallucination visual, completed suicide, suicidal behavior, major depression, depressed mood, depressive symptom, insomnia, disturbance in attention, somnolence, dizziness, or concentration impaired). The percentage of participants in either treatment group with CNS events was assessed over Weeks 0-24. | The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 24 |
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| Primary | Percentage of Participants With Virologic Response (HIV-1 RNA) < 40 Copies/mL) at Week 24: Doravirine (All Doses) vs Efavirenz (Part I) | Assessment of the virologic response to doravirine at all studied doses (25 mg, 50 mg, 100 mg, and 200 mg), compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <40 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification of 40 copies/mL. The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The Non-Completer = Failure (NC=F) approach, in which participants who prematurely discontinued assigned treatment for any reason and were considered as failures thereafter, was used as the primary approach to handle missing data this analysis of efficacy.This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I. | The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 24 weeks of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| Primary | Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification of 40 copies/mL. The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined. | The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 24 weeks of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 48. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined. | The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 48 weeks of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 96. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined. | The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 96 weeks of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 96 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 24: Doravirine (All Doses) vs Efavirenz (Part I) | Assessment of the virologic response to doravirine at all studied doses (25 mg, 50 mg, 100 mg, and 200 mg), compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay.The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The NC=F approach was used as the primary approach to handle missing data for this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I. | The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<200 copies/mL) at 24 weeks of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data for this analysis of efficacy. This secondary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I & Part II combined. | The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<200 copies/mL) at 24 weeks of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Evaluation of the antiretroviral activity of doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA for 24 weeks, as measured by the percentage of participants with HIV-1 RNA <200 copies/mL at Week 48. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. This primary outcome was analyzed for RNA <200 copies/mL in Part I & Part II combined. | The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV RNA (<200 copies/mL) at 48 weeks of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 96. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-96. The Non-Completer = Failure (NC=F) approach, in which participants who prematurely discontinued assigned treatment for any reason and were considered as failures thereafter, was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I & Part II combined. | The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<200 copies/mL) at 96 weeks of study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 96 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4 T Lymphocyte Cell Count at Week 24: Doravirine (All Doses) vs Efavirenz (Part I) | Evaluation of the change from baseline in the CD4 cell count at Week 24 in participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, and 200 mg), compared with participants receiving efavirenz 600 mg. The Observed Failure (OF) approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for participants who discontinued assigned treatment due to lack of efficacy. | The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of CD4 cell count at 24 weeks of study treatment. | Posted | Mean | 95% Confidence Interval | cells/mm^3 | Baseline, Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4 Cell Count at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the change from baseline in the CD4 cell count at Week 24 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for participants who discontinued assigned treatment due to lack of efficacy. | The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of CD4 cell count at 24 weeks of study treatment. | Posted | Mean | 95% Confidence Interval | cells/mm^3 | Baseline, Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4 Cell Count at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | Assessment of the change from baseline in the CD4 count at Week 48 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for subjects who discontinued assigned treatment due to lack of efficacy. | The analyzed population consisted of all randomized subjects who had baseline data, received at least 1 dose of blinded study medication in either Part I or Part II, and had at least 1 post-randomization observation for the analysis of CD4 cell count at 48 weeks of study treatment. | Posted | Mean | 95% Confidence Interval | cells/mm^3 | Baseline, Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4 Cell Count at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | A secondary endpoint in Part I/II combined was the change from baseline in the CD4 count at Week 96 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for subjects who discontinued assigned treatment due to lack of efficacy. | The analyzed population consisted of all randomized subjects who had baseline data, received at least 1 dose of blinded study medication in either Part I or Part II, and had at least 1 post-randomization observation for the analysis of CD4 cell count at 96 weeks of study treatment. | Posted | Mean | 95% Confidence Interval | cells/mm^3 | Baseline, Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With At Least 1 AE in Weeks 0-48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | A secondary outcome in Part I/II combined was the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 48 weeks of treatment. The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-48. | The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With At Least 1 AE in Weeks 0-96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined) | A secondary outcome in Part I/II combined was the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 96 weeks of treatment. The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-96. | The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 96 |
|
|
96 weeks
All Treated participants randomized to doravirine or efavirenz using an IVRS
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 | Doravirine 25 mg (n=40) | Doravirine 25 mg once daily plus TRUVADA once daily received in Part I | 4 | 40 | 31 | 40 | ||
| EG001 | Doravirine 50 mg (n=43) | Doravirine 50 mg once daily plus TRUVADA once daily received in Part I | 1 | 43 | 35 | 43 | ||
| EG002 | Doravirine 100 mg (n=108) | Doravirine 100 mg once daily plus TRUVADA once daily received in Part I & Part II (Combined) | 11 | 108 | 78 | 108 | ||
| EG003 | Doravirine 200 mg (n=41) | Doravirine 200 mg once daily plus TRUVADA once daily received in Part I | 3 | 41 | 36 | 41 | ||
| EG004 | Efavirenz 600 mg: Part I (n=108) | Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I & Part II (Combined) | 13 | 108 | 82 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiomyopathy | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Acute hepatitis C | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cryptosporidiosis infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis shigella | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Foreign body | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| B-cell unclassifiable lymphoma high grade | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bipolar I disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000592662 | doravirine |
| C098320 | efavirenz |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Non-Compliance with Study Drug |
|
| Physician Decision |
|
| Pregnancy |
|
| Protocol Deviation |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Non-Compliance with Study Drug |
|
| Withdrawal by Subject |
|
| Male |
|
| Difference (Doravirine - Efavirenz) |
| 9.7 |
| 2-Sided |
| 95 |
| -4.6 |
| 24.9 |
A negative value would be considered as favoring doravirine over efavirenz. |
| Superiority or Other |
| Difference (Doravirine - Efavirenz) | -11.9 | 2-Sided | 95 | -27.9 | 6.3 | A negative value would be considered as favoring doravirine over efavirenz. | Superiority or Other |
| Difference (Doravirine - Efavirenz) | 2.0 | 2-Sided | 95 | -14.5 | 18.4 | A negative value would be considered as favoring doravirine over efavirenz. | Superiority or Other |
| OG003 | Doravirine 200 mg: Part I | Doravirine 200 mg once daily plus TRUVADA once daily received in Part I |
| OG004 | Efavirenz 600 mg: Part I | Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
Doravirine 50 mg once daily plus TRUVADA once daily received in Part I
| OG002 | Doravirine 100 mg: Part I | Doravirine 100 mg once daily plus TRUVADA once daily received in Part I |
| OG003 | Doravirine 200 mg: Part I | Doravirine 200 mg once daily plus TRUVADA once daily received in Part I |
| OG004 | Efavirenz 600 mg: Part I | Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I |
|
|
|
|
|
|
|
|
|
|
|
|
| Doravirine 100 mg: Part I |
Doravirine 100 mg once daily plus TRUVADA once daily received in Part I |
| OG003 | Doravirine 200 mg: Part I | Doravirine 200 mg once daily plus TRUVADA once daily received in Part I |
| OG004 | Efavirenz 600 mg: Part I | Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
Efavirenz 600 mg once daily plus TRUVADA once daily received in either Part I or Part II
|
|
|
| OG003 | Doravirine 200 mg: Part I | Doravirine 200 mg once daily plus TRUVADA once daily received in Part I |
| OG004 | Efavirenz 600 mg: Part I | Efavirenz 600 mg once daily plus TRUVADA once daily received in Part I |
|
|
|
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
|