Trial · NCT02275780
Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)
NCT02275780, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2018-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018). Trials, record NCT02275780. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02275780
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)
- NCT number
- NCT02275780
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 769 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- HIV-1
- Interventions
- Doravirine, Darunavir, Ritonavir, TRUVADA™ or EPZICOM™/KIVEXA™
- First posted
- 2014-10-27
- Last updated
- 2024-10-01
- Other registries' IDs
- eudract:2014-001127-69
- Results first posted
- 2018-10-23
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 48 | 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. |
| Secondary | Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 96 | 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. |
| Secondary | Change From Baseline in Mean CD4+ T-cell Count at Week 48 | Baseline and Week 48 | CD4+ T-cell counts were quantified by a central laboratory using a commercially available assay. |
| Secondary | Change From Baseline in Mean CD4+ T-cell Count at Week 96 | Baseline and Week 96 | CD4+ T-cell counts were quantified by a central laboratory using a commercially available assay. |
| Secondary | Mean Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 48 | Baseline and 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. |
| Secondary | Mean Change From Baseline in Fasting Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 48 | Baseline and 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. |
| Secondary | Mean Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 48 | Baseline and 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. |
| Secondary | Mean Change From Baseline in Fasting Total Cholesterol at Week 48 | Baseline and 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. |
| Secondary | Mean Change From Baseline in Fasting Triglyceride at Week 48 | Baseline and 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. |
| Secondary | Percentage of Participants With Any Adverse Event | Up to 98 weeks | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 48 | Week 48 | All randomized participants who received at least 1 dose of study drug | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 96 | Week 96 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Mean CD4+ T-cell Count at Week 48 | Baseline and Week 48 | 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. | Cells/mm^3 | MEAN |
| SECONDARY | Change From Baseline in Mean CD4+ T-cell Count at Week 96 | Baseline and Week 96 | 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. | Cells/mm^3 | MEAN |
| SECONDARY | Mean Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 48 | Baseline and Week 48 | All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed. | mg/dL | MEAN |
| SECONDARY | Mean Change From Baseline in Fasting Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 48 | Baseline and Week 48 | All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed. | mg/dL | MEAN |
| SECONDARY | Mean Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 48 | Baseline and Week 48 | All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed. | mg/dL | MEAN |
| SECONDARY | Mean Change From Baseline in Fasting Total Cholesterol at Week 48 | Baseline and Week 48 | All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed. | mg/dL | MEAN |
| SECONDARY | Mean Change From Baseline in Fasting Triglyceride at Week 48 | Baseline and Week 48 | All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed. | mg/dL | MEAN |
| SECONDARY | Percentage of Participants With Any Adverse Event | Up to 98 weeks | All randomized participants who received at least 1 dose of study drug | Percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 48 | Doravirine 100 mg | 83.8 | Percentage of participants | ||
| Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 48 | Daurunavir 800 mg + Ritonavir 100 mg | 79.9 | Percentage of participants | ||
| Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 96 | Doravirine 100 mg | 73.1 | Percentage of participants | ||
| Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 96 | Daurunavir 800 mg + Ritonavir 100 mg | 66.0 | Percentage of participants | ||
| Change From Baseline in Mean CD4+ T-cell Count at Week 48 | Doravirine 100 mg | 192.7 | 95% Confidence Interval 171.5 to 213.9 | Cells/mm^3 | |
| Change From Baseline in Mean CD4+ T-cell Count at Week 48 | Daurunavir 800 mg + Ritonavir 100 mg | 185.6 | 95% Confidence Interval 167.5 to 203.6 | Cells/mm^3 | |
| Change From Baseline in Mean CD4+ T-cell Count at Week 96 | Doravirine 100 mg | 224.1 | 95% Confidence Interval 200.8 to 247.4 | Cells/mm^3 | |
| Change From Baseline in Mean CD4+ T-cell Count at Week 96 | Daurunavir 800 mg + Ritonavir 100 mg | 206.7 | 95% Confidence Interval 184.9 to 228.5 | Cells/mm^3 | |
| Mean Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 48 | Doravirine 100 mg | Baseline | 91.10 | Standard Deviation 28.61 | mg/dL |
| Mean Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 48 | Daurunavir 800 mg + Ritonavir 100 mg | Baseline | 91.76 | Standard Deviation 30.36 | mg/dL |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow26
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Base Study: 96 Weeks | STARTED | Doravirine 100 mg | 385 | |
| Base Study: 96 Weeks | STARTED | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | 384 | |
| Base Study: 96 Weeks | Treated | Doravirine 100 mg | 383 | |
| Base Study: 96 Weeks | Treated | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | 383 | |
| Base Study: 96 Weeks | COMPLETED | Doravirine 100 mg | 292 | |
| Base Study: 96 Weeks | COMPLETED | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | 273 | |
| Base Study: 96 Weeks | NOT COMPLETED | Doravirine 100 mg | 93 | |
| Base Study: 96 Weeks | NOT COMPLETED | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | 111 | |
| Study Extension 1: Week 96 to Week 192 | STARTED | Doravirine 100 mg | 259 | |
| Study Extension 1: Week 96 to Week 192 | STARTED | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | 233 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 participant flowAdverse events278
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Doravirine 100 mg | 20 | 383 | 22 |
| other | Abdominal pain | Gastrointestinal disorders | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | 20 | 383 | 25 |
| other | Abdominal pain upper | Gastrointestinal disorders | Doravirine 100 mg | 27 | 383 | 30 |
| other | Abdominal pain upper | Gastrointestinal disorders | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | 15 | 383 | 18 |
| other | Diarrhoea | Gastrointestinal disorders | Doravirine 100 mg | 72 | 383 | 87 |
| other | Diarrhoea | Gastrointestinal disorders | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | 100 | 383 | 136 |
| other | Nausea | Gastrointestinal disorders | Doravirine 100 mg | 52 | 383 | 65 |
| other | Nausea | Gastrointestinal disorders | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | 54 | 383 | 64 |
| other | Vomiting | Gastrointestinal disorders | Doravirine 100 mg | 20 | 383 | 32 |
| other | Vomiting | Gastrointestinal disorders | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | 12 | 383 | 14 |
1 to 10 of 278Source ClinicalTrials.gov
See all 278 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doravirine 100 mg | 3 | 385 |
| Total, all-cause mortality | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | 3 | 384 |
| Total, other adverse events | Doravirine 100 mg | 264 | 383 |
| Total, other adverse events | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | 247 | 383 |
| Total, serious adverse events | Doravirine 100 mg | 45 | 383 |
| Total, serious adverse events | Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg | 49 | 383 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Doravirine 100 mg vs Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg: deaths from any cause | Trial comparisons |
| Doravirine 100 mg vs Daurunavir 800 mg + Ritonavir 100 mg → Doravirine 100 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02275780
GET https://conductscience.org/api/trials/v1/NCT02275780/results?page=2