Trial · NCT02607956
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
NCT02607956, Phase 3, Completed, Gilead Sciences; results first posted 2018-06-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults. Trials, record NCT02607956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02607956
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
- NCT number
- NCT02607956
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 657 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- HIV-1 Infection
- Interventions
- DTG, F/TAF, B/F/TAF, DTG Placebo, F/TAF Placebo, B/F/TAF Placebo
- First posted
- 2015-11-18
- Last updated
- 2022-03-07
- Other registries' IDs
- eudract:2015-003988-10
- Results first posted
- 2018-06-06
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | Week 48 | The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Secondary | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | Week 96 | The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Secondary | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm | Week 144 | The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Secondary | Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | Week 48 | The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Secondary | Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | Week 96 | The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Secondary | Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm | Week 144 | The percentage of participants achieving HIV-1 RNA \< 20 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. |
| Secondary | Change From Baseline in log10 HIV-1 RNA at Week 48 | Baseline, Week 48 | |
| Secondary | Change From Baseline in log10 HIV-1 RNA at Week 96 | Baseline, Week 96 | |
| Secondary | Change From Baseline in log10 HIV-1 RNA at Week 144 | Baseline, Week 144 | |
| Secondary | Change From Baseline in CD4+ Cell Count at Week 48 | Baseline, Week 48 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | Week 48 | Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | Week 96 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm | Week 144 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | Week 48 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | Week 96 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm | Week 144 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in log10 HIV-1 RNA at Week 48 | Baseline, Week 48 | Participants in the Full Analysis Set with available data were analyzed. | log10 copies/mL | MEAN |
| SECONDARY | Change From Baseline in log10 HIV-1 RNA at Week 96 | Baseline, Week 96 | Participants in the Full Analysis Set with available data were analyzed. | log10 copies/mL | MEAN |
| SECONDARY | Change From Baseline in log10 HIV-1 RNA at Week 144 | Baseline, Week 144 | Participants in the Full Analysis Set with available data were analyzed. | log10 copies/mL | MEAN |
| SECONDARY | Change From Baseline in CD4+ Cell Count at Week 48 | Baseline, Week 48 | Participants in the Full Analysis Set with available data were analyzed. | cells/μL | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | B/F/TAF | 89.4 | percentage of participants | ||
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | DTG + F/TAF | 92.9 | percentage of participants | ||
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | B/F/TAF | 84.1 | percentage of participants | ||
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | DTG + F/TAF | 86.5 | percentage of participants | ||
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm | B/F/TAF | 81.9 | percentage of participants | ||
| Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm | DTG + F/TAF | 84.0 | percentage of participants | ||
| Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | B/F/TAF | 82.2 | percentage of participants | ||
| Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm | DTG + F/TAF | 87.1 | percentage of participants | ||
| Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | B/F/TAF | 77.5 | percentage of participants | ||
| Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm | DTG + F/TAF | 80.3 | percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blinded Phase | STARTED | B/F/TAF | 327 | |
| Double-Blinded Phase | STARTED | DTG + F/TAF | 330 | |
| Double-Blinded Phase | STARTED | B/F/TAF to B/F/TAF | 0 | |
| Double-Blinded Phase | STARTED | DTG + F/TAF to B/F/TAF | 0 | |
| Double-Blinded Phase | COMPLETED | B/F/TAF | 266 | |
| Double-Blinded Phase | COMPLETED | DTG + F/TAF | 277 | |
| Double-Blinded Phase | COMPLETED | B/F/TAF to B/F/TAF | 0 | |
| Double-Blinded Phase | COMPLETED | DTG + F/TAF to B/F/TAF | 0 | |
| Double-Blinded Phase | NOT COMPLETED | B/F/TAF | 61 | |
| Double-Blinded Phase | NOT COMPLETED | DTG + F/TAF | 53 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events876
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 | Lymphadenopathy | Blood and lymphatic system disorders | B/F/TAF | 24 | 320 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | DTG + F/TAF | 23 | 325 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | B/F/TAF to B/F/TAF | 5 | 254 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | DTG + F/TAF to B/F/TAF | 3 | 265 | |
| other | Abdominal pain | Gastrointestinal disorders | B/F/TAF | 23 | 320 | |
| other | Abdominal pain | Gastrointestinal disorders | DTG + F/TAF | 23 | 325 | |
| other | Abdominal pain | Gastrointestinal disorders | B/F/TAF to B/F/TAF | 4 | 254 | |
| other | Abdominal pain | Gastrointestinal disorders | DTG + F/TAF to B/F/TAF | 7 | 265 | |
| other | Abdominal pain upper | Gastrointestinal disorders | B/F/TAF | 16 | 320 | |
| other | Abdominal pain upper | Gastrointestinal disorders | DTG + F/TAF | 13 | 325 |
1 to 10 of 876Source ClinicalTrials.gov
See all 876 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | B/F/TAF | 4 | 327 |
| Total, all-cause mortality | DTG + F/TAF | 4 | 330 |
| Total, all-cause mortality | B/F/TAF to B/F/TAF | 1 | 254 |
| Total, all-cause mortality | DTG + F/TAF to B/F/TAF | 3 | 265 |
| Total, other adverse events | B/F/TAF | 250 | 320 |
| Total, other adverse events | DTG + F/TAF | 262 | 325 |
| Total, other adverse events | B/F/TAF to B/F/TAF | 165 | 254 |
| Total, other adverse events | DTG + F/TAF to B/F/TAF | 163 | 265 |
| Total, serious adverse events | B/F/TAF | 64 | 320 |
| Total, serious adverse events | DTG + F/TAF | 46 | 325 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers12
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02607956
GET https://conductscience.org/api/trials/v1/NCT02607956/results?page=2