Trial · NCT02269917
Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants
NCT02269917, Phase 3, Completed, Janssen R&D Ireland; results first posted 2018-11-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants. Trials, record NCT02269917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02269917
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Regimen Versus Boosted Protease Inhibitor (bPI) Along With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) Regimen in Virologically-Suppressed, HIV-1 Infected Participants
- NCT number
- NCT02269917
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,149 participants, actual
- Lead sponsor
- Janssen R&D Ireland
- Conditions
- Human Immunodeficiency Virus Type 1
- Interventions
- D/C/F/TAF, Boosted Protease Inhibitor (bPI), FTC/TDF
- First posted
- 2014-10-21
- Last updated
- 2021-12-09
- Other registries' IDs
- eudract:2014-003052-31
- Results first posted
- 2018-11-09
- Limitations and caveats
- The limitation of the study was the open-label design.
Source ClinicalTrials.gov
Registered outcomes57
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Virologic Rebound (HIV-1 RNA >=50 Copies/mL) Cumulative Through Week 48 | Through Week 48 | Virologic rebound was defined as: confirmed plasma human immunodeficiency virus - 1 (HIV-1) Ribonucleic Acid (RNA) level greater than or equal to (\>=)50 copies per milliliter (copies/mL) up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA \>=50 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported. |
| Secondary | Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=20 Copies/mL) Cumulative Through 48 Weeks | Through 48 Weeks | Virologic rebound was defined as: confirmed plasma HIV-1 RNA \>=20 copies/mL up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA \>=20 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported. |
| Secondary | Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=200 Copies/mL) Cumulative Through 48 Weeks | Through 48 Weeks | Virologic rebound was defined as: confirmed plasma HIV-1 RNA \>=200 copies/mL up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA \>=200 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported. |
| Secondary | Percentage of Participants With Non-Virologic Rebound at Week 48 by Kaplan-Meier Estimates | Baseline up to Week 48 | Virologic rebound was defined as: confirmed plasma HIV-1 RNA \>=50 copies/mL up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA \>=50 copies/mL at premature discontinuation (irrespective of reason). Here Kaplan-Meier estimates percentage of participants with non-virologic rebound at week 48. |
| Secondary | Percentage of Participants Experiencing Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuation Due to AEs Through Week 48 | Up to Week 48 | An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events were symptoms causing inability to perform usual social \& functional activities. Grade 4 (Life-threatening) events were symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. |
| Secondary | Change From Baseline in Serum Creatinine Levels at Weeks 24 and 48 | Baseline and Weeks 24 and 48 | Change from baseline in serum creatinine levels at Weeks 24 and 48 was assessed. |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Cockcroft-Gault Formula [eGFRcg]) at Weeks 24 and 48 | Baseline, Weeks 24 and 48 | Change from baseline in eGFRcr (by Cockcroft-Gault formula) was assessed at Weeks 24 and 48. eGFRcr according to the Cockcroft Gault formula- Male: (140 - age in years)\*(weight in kilogram \[kg\])/72\*(serum creatinine in milligram per deciliter \[mg/dL\])=eGFRcr (milliliter per minute \[mL/min\]); Female: (140 - age in years)\*(weight in kg)/72\*(serum creatinine in mg/dL)\*0.85=eGFRcr (mL/min). |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at Weeks 24 and 48 | Baseline, Weeks 24 and 48 | Change from baseline in eGFRcr (by CKD-EPI) was assessed at Weeks 24 and 48. eGFRcr per CKD-EPI formula - Female: 1) Serum creatinine (Scr) less than or equal to (\<=)0.7 mg/dL: 144\*(Scr/0.7)\^-0.329\*0.993age; 2) Scr greater than (\>)0.7 mg/dL: 144\*(Scr/0.7)\^-1.209\*0.993age. Male: 1) Scr \<=0.9 mg/dL: 141\*(Scr/0.9)\^-0.411\*0.993age; 2) Scr \>0.9 mg/dL: 141\*(Scr/0.9)\^-1.209\*0.993age. |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst, by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at Weeks 24 and 48 | Baseline, Weeks 24 and 48 | Change from baseline in eGFRcyst (by CKD-EPI) was assessed at Weeks 24 and 48. eGFRcyst according to the CKD-EPI formula - 1) Serum Cystatin C (Scyst) \<=0.8 mg/L: 133\*(Scyst/0.8)\^-0.499\*0.996age (\*0.932 if female); 2) Scyst \>0.8 mg/L: 133\*(Scyst/0.8)\^-1.328\*0.996age (\*0.932 if female). |
| Secondary | Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR) at Weeks 24 and 48 | Baseline, Weeks 24 and 48 | Change from baseline in UACR and UPCR was assessed at Weeks 24 and 48. Lower levels of albumin or protein in the urine indicates better proximal tubular function. |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 registered outcomesOutcomes57
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Virologic Rebound (HIV-1 RNA >=50 Copies/mL) Cumulative Through Week 48 | Through Week 48 | Intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=20 Copies/mL) Cumulative Through 48 Weeks | Through 48 Weeks | ITT analysis set included all participants who were randomized and received at least 1 dose of study treatment. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=200 Copies/mL) Cumulative Through 48 Weeks | Through 48 Weeks | ITT analysis set included all participants who were randomized and received at least 1 dose of study treatment. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Non-Virologic Rebound at Week 48 by Kaplan-Meier Estimates | Baseline up to Week 48 | ITT analysis set included all participants who were randomized and received at least 1 dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuation Due to AEs Through Week 48 | Up to Week 48 | ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Serum Creatinine Levels at Weeks 24 and 48 | Baseline and Weeks 24 and 48 | ITT analysis set included all participants randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this endpoint; and 'n' specifies participants analyzed for this endpoint at given time point. | micro mole per liter | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Cockcroft-Gault Formula [eGFRcg]) at Weeks 24 and 48 | Baseline, Weeks 24 and 48 | ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this endpoint; and 'n' specifies those participants who were analyzed for this endpoint at given time point. | milliliter per minute (mL/min) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at Weeks 24 and 48 | Baseline, Weeks 24 and 48 | ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this endpoint; and 'n' specifies those participants who were analyzed for this endpoint at given time point. | mL/min/1.73 m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst, by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at Weeks 24 and 48 | Baseline, Weeks 24 and 48 | ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, 'n' specifies those participants who were analyzed for this endpoint at given time point. | mL/min/1.73 m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR) at Weeks 24 and 48 | Baseline, Weeks 24 and 48 | ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this endpoint; and 'n' specifies those participants who were analyzed for this endpoint at given time point. | milligram per gram (mg/g) | MEDIAN |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 outcomesResults by group312
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Virologic Rebound (HIV-1 RNA >=50 Copies/mL) Cumulative Through Week 48 | D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) | 2.5 | 95% Confidence Interval 1.5 to 3.9 | Percentage of participants | |
| Percentage of Participants With Virologic Rebound (HIV-1 RNA >=50 Copies/mL) Cumulative Through Week 48 | Control (Baseline to Switch) | 2.1 | 95% Confidence Interval 0.9 to 4.1 | Percentage of participants | |
| Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=20 Copies/mL) Cumulative Through 48 Weeks | D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) | 10.5 | 95% Confidence Interval 8.4 to 12.9 | Percentage of Participants | |
| Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=20 Copies/mL) Cumulative Through 48 Weeks | Control (Baseline to Switch) | 11.4 | 95% Confidence Interval 8.4 to 15.0 | Percentage of Participants | |
| Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=200 Copies/mL) Cumulative Through 48 Weeks | D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) | 0.4 | 95% Confidence Interval 0.1 to 1.1 | Percentage of Participants | |
| Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=200 Copies/mL) Cumulative Through 48 Weeks | Control (Baseline to Switch) | 0.0 | 95% Confidence Interval NA to NA | Percentage of Participants | |
| Percentage of Participants With Non-Virologic Rebound at Week 48 by Kaplan-Meier Estimates | D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) | 97.7 | 95% Confidence Interval 96.4 to 98.6 | percentage of participants | |
| Percentage of Participants With Non-Virologic Rebound at Week 48 by Kaplan-Meier Estimates | Control (Baseline to Switch) | 97.8 | 95% Confidence Interval 95.7 to 98.9 | percentage of participants | |
| Percentage of Participants Experiencing Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuation Due to AEs Through Week 48 | D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) | Grade 3 AEs | 5.6 | Percentage of Participants | |
| Percentage of Participants Experiencing Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuation Due to AEs Through Week 48 | Control (Baseline to Switch) | Grade 3 AEs | 6.3 | Percentage of Participants |
1 to 10 of 312Source ClinicalTrials.gov
See all 312 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| BL to EOE-Test and BL to Switch-Control | STARTED | D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) | 766 | |
| BL to EOE-Test and BL to Switch-Control | STARTED | Control (Baseline to Switch) | 383 | |
| BL to EOE-Test and BL to Switch-Control | STARTED | Switch to D/C/F/TAF | 0 | |
| BL to EOE-Test and BL to Switch-Control | Treated | D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) | 763 | |
| BL to EOE-Test and BL to Switch-Control | Treated | Control (Baseline to Switch) | 378 | |
| BL to EOE-Test and BL to Switch-Control | Treated | Switch to D/C/F/TAF | 0 | |
| BL to EOE-Test and BL to Switch-Control | COMPLETED | D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) | 649 | |
| BL to EOE-Test and BL to Switch-Control | COMPLETED | Control (Baseline to Switch) | 352 | |
| BL to EOE-Test and BL to Switch-Control | COMPLETED | Switch to D/C/F/TAF | 0 | |
| BL to EOE-Test and BL to Switch-Control | NOT COMPLETED | D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) | 117 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events615
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 | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 64 | 763 | |
| other | Abdominal pain | Gastrointestinal disorders | Control (Baseline to Switch) | 7 | 378 | |
| other | Abdominal pain | Gastrointestinal disorders | Switch to D/C/F/TAF Group | 9 | 352 | |
| other | Diarrhoea | Gastrointestinal disorders | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 104 | 763 | |
| other | Diarrhoea | Gastrointestinal disorders | Control (Baseline to Switch) | 18 | 378 | |
| other | Diarrhoea | Gastrointestinal disorders | Switch to D/C/F/TAF Group | 40 | 352 | |
| other | Nausea | Gastrointestinal disorders | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 41 | 763 | |
| other | Nausea | Gastrointestinal disorders | Control (Baseline to Switch) | 8 | 378 | |
| other | Nausea | Gastrointestinal disorders | Switch to D/C/F/TAF Group | 12 | 352 | |
| other | Vomiting | Gastrointestinal disorders | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 41 | 763 |
1 to 10 of 615Source ClinicalTrials.gov
See all 615 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 4 | 763 |
| Total, all-cause mortality | Control (Baseline to Switch) | 0 | 378 |
| Total, all-cause mortality | Switch to D/C/F/TAF Group | 1 | 352 |
| Total, other adverse events | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 584 | 763 |
| Total, other adverse events | Control (Baseline to Switch) | 222 | 378 |
| Total, other adverse events | Switch to D/C/F/TAF Group | 213 | 352 |
| Total, serious adverse events | D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 114 | 763 |
| Total, serious adverse events | Control (Baseline to Switch) | 18 | 378 |
| Total, serious adverse events | Switch to D/C/F/TAF Group | 42 | 352 |
Source ClinicalTrials.gov
Papers5
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) vs Control (Baseline to Switch): Number of Participants With Resistance to Study Drug |
Source 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/NCT02269917
GET https://conductscience.org/api/trials/v1/NCT02269917/registered?page=2