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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004779-21 | EudraCT Number |
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The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed HIV-1 infected participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FTC/RPV/TAF | Experimental | FTC/RPV/TAF plus EFV/FTC/TDF placebo for at least 96 weeks. |
|
| EFV/FTC/TDF | Active Comparator | EFV/FTC/TDF plus FTC/RPV/TAF placebo for at least 96 weeks. |
|
| Open Label Extension Phase | Experimental | After the Week 96 visit, participants will be given the option to receive open label FTC/RPV/TAF for up to an additional 48 weeks. In countries where FTC/RPV/TAF is not yet commercially available, participants will be given the option to receive open-label FTC/RPV/TAF and attend visits every 12 weeks until FTC/RPV/TAF becomes commercially available, or until Gilead elects to discontinue the study, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FTC/RPV/TAF | Drug | 200/25/25 mg FDC tablets administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm | The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maricopa Integrated Health System | Phoenix | Arizona | 85004 | United States | ||
| Spectrum Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30101539 | Result | Hagins D, Orkin C, Daar ES, Mills A, Brinson C, DeJesus E, Post FA, Morales-Ramirez J, Thompson M, Osiyemi O, Rashbaum B, Stellbrink HJ, Martorell C, Liu H, Liu YP, Porter D, Collins SE, SenGupta D, Das M. Switching to coformulated rilpivirine (RPV), emtricitabine (FTC) and tenofovir alafenamide from either RPV, FTC and tenofovir disoproxil fumarate (TDF) or efavirenz, FTC and TDF: 96-week results from two randomized clinical trials. HIV Med. 2018 Nov;19(10):724-733. doi: 10.1111/hiv.12664. Epub 2018 Aug 12. | |
| Result | Mills A, Brinson C, Martorell C, Crofoot G, Daar E, Osiyemi O, et al. Switching to RPV/FTC/TAF from RPV/FTC/TDF or EFV/FTC/TDF: Week 96 Results. Conference on Retroviruses and Opportunistic Infections, Boston. March 4-7, 2018, Abstract 504. | ||
| Result | Arribas JR, Rockstroh J, Post, Yazdanpanah Y, Cavassini, DeJesus E, et al. Bone and renal safety of switching to rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF) from single-tablet regimens (STRs) containing efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) or rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF): Week 48 subgroup analysis in patients at risk of or with comorbidities. Abstract accepted for presentation at the 16th European AIDS Conference, 2017 25-27 October Milan, Italy. |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and transparency
18 months after study completion
A secured external environment with username, password, and RSA code
974 participants were screened.
Participants were enrolled at study sites in Europe and North America. The first participant was screened on 26 January 2015. The last study visit occurred on 02 January 2019.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | FTC/RPV/TAF | Double-Blind Phase: Emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) (200/25/25 mg) fixed-dose combination (FDC) tablet + efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) placebo tablet orally once daily for up to 96 weeks. Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily and attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-Blind Phase |
|
Not provided
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| EFV/FTC/TDF Placebo | Drug | Tablets administered orally once daily |
|
| EFV/FTC/TDF | Drug | 600/200/300 mg FDC tablets administered orally once daily |
|
|
| FTC/RPV/TAF Placebo | Drug | Tablets administered orally once daily |
|
| Week 48 |
| Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot Algorithm | The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient'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. | Week 96 |
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient'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. | Week 96 |
| Change From Baseline in CD4+ Cell Count at Week 48 | Baseline; Week 48 |
| Change From Baseline in CD4+ Cell Count at Week 96 | Baseline; Week 96 |
| Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. | Baseline; Week 48 |
| Percent Change From Baseline in Hip BMD at Week 96 | Hip BMD was assessed by DXA scan. | Baseline; Week 96 |
| Percent Change From Baseline in Spine BMD at Week 48 | Spine BMD was assessed by DXA scan. | Baseline; Week 48 |
| Percent Change From Baseline in Spine BMD at Week 96 | Spine BMD was assessed by DXA scan. | Baseline; Week 96 |
| Change From Baseline in HIV Symptoms Index Score (HIVSI) at Week 48 | The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing. | Baseline; Week 48 |
| Change From Baseline in HIVSI Score at Week 96 | The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing. | Baseline; Week 96 |
| Phoenix |
| Arizona |
| United States |
| AHF Research Center | Beverly Hills | California | United States |
| Pacific Oaks Medical Group | Beverly Hills | California | United States |
| Long Beach Education and Research Consultants | Long Beach | California | United States |
| Kaiser Permanente | Los Angeles | California | United States |
| Southern California Men's Medical Group | Los Angeles | California | United States |
| Tarrant County ID Associates | Los Angeles | California | United States |
| Kaiser Permanente | Sacramento | California | United States |
| University of California-UC Davis | Sacramento | California | United States |
| La Playa Medical Group and Clinical Research | San Diego | California | United States |
| Kaiser Permanente | San Francisco | California | United States |
| Optimus Medical | San Francisco | California | United States |
| Kaiser Permanente | San Leandro | California | United States |
| Los Angeles BioMedical Institute at Harbor-UCLA Medical Center | Torrance | California | United States |
| University of Colorado | Aurora | Colorado | United States |
| Apex Research Institute | Denver | Colorado | United States |
| Yale University School of Medicine | New Haven | Connecticut | United States |
| World Health Clinicians' CIRCLE CARE Center | Norwalk | Connecticut | United States |
| Capital Medical Associates, P.C. | Washington D.C. | District of Columbia | United States |
| Medical Faculty Associates, Inc. | Washington D.C. | District of Columbia | United States |
| Whitman Walker Clinic | Washington D.C. | District of Columbia | United States |
| Gary Richmond, MD, PA, Inc. | Fort Lauderdale | Florida | United States |
| Therafirst Medical Centers | Fort Lauderdale | Florida | United States |
| Midway Immunology & Research Center, LLC | Ft. Pierce | Florida | United States |
| AIDS Healthcare Foundation | Miami | Florida | United States |
| University of Miami | Miami | Florida | United States |
| AIDS Healthcare Foundation | Miami Beach | Florida | United States |
| Orlando Immunology Center | Orlando | Florida | United States |
| Infectious Diseases Associates of NW Florida, P.A. | Pensacola | Florida | United States |
| Hillsborough County Health Dept. | Tampa | Florida | United States |
| Infectious Disease Research Institute Inc. | Tampa | Florida | United States |
| St. Joseph's Comprehensive Research Institute | Tampa | Florida | United States |
| AIDS Research & Treatment Center of the Treasure Coast | Vero Beach | Florida | United States |
| Triple O Research Institute, P.A. | West Palm Beach | Florida | United States |
| Rowan Tree Medical PA | Wilton Manors | Florida | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | United States |
| Atlanta ID Group | Atlanta | Georgia | United States |
| Infectious Disease Specialists of Atlanta | Decatur | Georgia | United States |
| Mercer University School of Medicine | Macon | Georgia | United States |
| Chatham County Health Department | Savannah | Georgia | United States |
| The CORE Foundation | Chicago | Illinois | United States |
| Indiana University Medical Center | Indianapolis | Indiana | United States |
| Boston University Medical Center | Boston | Massachusetts | United States |
| Brigham and Women's | Boston | Massachusetts | United States |
| MetroWest Medical Center | Framingham | Massachusetts | United States |
| Baystate Infectious Diseases Clinical Research | Springfield | Massachusetts | United States |
| The Research Institute | Springfield | Massachusetts | United States |
| Be Well Medical Center | Berkley | Michigan | United States |
| Henry Ford Health System | Detroit | Michigan | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | United States |
| Southampton Healthcare, Inc. | St Louis | Missouri | United States |
| Saint Michael's Medical Center | Newark | New Jersey | United States |
| South Jersey Infectious Disease | Somers Point | New Jersey | United States |
| Southwest CARE Center | Santa Fe | New Mexico | United States |
| Upstate Infectious Diseases Associates | Albany | New York | United States |
| North Shore University Hospital | Manhasset | New York | United States |
| Columbia University Medical Center/ New York Presbyterian | New York | New York | United States |
| Jacobi Medical Center | The Bronx | New York | United States |
| Montefiore Medical Center | The Bronx | New York | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States |
| Infectious Disease Consultants, PA | Charlotte | North Carolina | United States |
| The Brody School of Medicine | Greenville | North Carolina | United States |
| Rosedale Infectious Diseases | Huntersville | North Carolina | United States |
| The Ohio State University | Columbus | Ohio | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | United States |
| The Miriam Hospital | Providence | Rhode Island | United States |
| Medical University of South Carolina | Charleston | South Carolina | United States |
| Central Texas Clinical Research | Austin | Texas | United States |
| North Texas Infectious Diseases Consultants | Dallas | Texas | United States |
| Southwest Infectious Disease Clinical Research, Inc. | Dallas | Texas | United States |
| Trinity Health and Wellness Center/AIDS Arms, Inc. | Dallas | Texas | United States |
| AIDS Arms, Inc./Trinity Health & Wellness Center | Fort Worth | Texas | United States |
| Gordon E. Crofoot, MD, PA | Houston | Texas | United States |
| Research Access Network | Houston | Texas | United States |
| DCOL Center for Clinical Research | Longview | Texas | United States |
| Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID) | Annandale | Virginia | United States |
| Peter Shalit, MD | Seattle | Washington | United States |
| Premier Clinical Research | Spokane | Washington | United States |
| CHU Saint-Pierre University Hospital | Brussels | Belgium |
| Cliniques Universitaires UCL Saint-Luc | Brussels | Belgium |
| University of Alberta | Edmonton | Alberta | Canada |
| Spectrum Health | Vancouver | British Columbia | Canada |
| Health Sciences Centre | Winnipeg | Manitoba | Canada |
| Maple Leaf Research | Toronto | Ontario | Canada |
| University Health Network | Toronto | Ontario | Canada |
| Clinique medicale l'Actuel | Montreal | Quebec | Canada |
| Clinique OPUS | Montreal | Quebec | Canada |
| McGill University Health Centre | Montreal | Quebec | Canada |
| Hopital Bichat Claude Bernard | Paris | France |
| Hopital Saint Louis | Paris | France |
| Chu Tours | Tours | France |
| Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH (zibp) | Berlin | Germany |
| University of Bonn | Bonn | Germany |
| Universitat zu Koln | Cologne | Germany |
| Center for HIV and Hepatogastroenterology | Düsseldorf | Germany |
| Universitätsklinikum Essen | Essen | Germany |
| Infektiologikum | Frankfurt | Germany |
| ICH Study Center Hamburg | Hamburg | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | Germany |
| MUC Research GmbH | München | Germany |
| Clinical Research Puerto Rico Inc | San Juan | Puerto Rico |
| Hope Clinical Research | San Juan | Puerto Rico |
| University of Puerto Rico School of Medicine | San Juan | Puerto Rico |
| Hospital General Universitario de Alicante | Alicante | Spain |
| Hospital Clinic i Provincial | Barcelona | Spain |
| Hospital del Mar | Barcelona | Spain |
| Hospital Universitary de Bellvitge | Barcelona | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| University Hospital Basel | Basel | Switzerland |
| Geneva University Hospital | Geneva | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland |
| Barts & The London NHS Trust | London | United Kingdom |
| King's College Hospital | London | United Kingdom |
| Mortimer Market Centre | London | United Kingdom |
| The Royal Free Hampstead NHS Trust | London | United Kingdom |
| Result | Porter DP, KulkarniR, Cao H, SenGupta D, and White KL. No Emergent Resistance in HIV-1 Virologically-Suppressed Subjects Who Switched to RPV/FTC/TAF [Poster 1381]. ID Week 2017 4-8 October; San Diego, California. |
| Result | E DeJesus, M Ramgopal, G Crofoot, P Ruane, A LaMarca. J-M Molina et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Older Adults. 8th International Workshop on HIV and Aging 2017 2-3 October, New York, New York. |
| Result | Molina JM, DeJesus E, Rijnders B, Post FAV, B., Stoeckle M, ThalmeA, et al. Efficacy and Safety of Switching From RPV/FTC/TDF or EFV/FTC/TDF to RPV/FTC/TAF in Black Adults [Presentation MOPEB0291]. 9th IAS Conference on HIV Science 2017 23-26 July Paris, France. |
| Result | Rockstroh J, Orkin C, Yazdanpanah Y, Di Perri GDS, P. E., Arribas JR, Brinkman K, et al. Switching From TDF to TAF Improves Bone and Renal Safety Independent of Age, Sex, Race, or 3rd Agent: Results From Pooled Analysis (N=3816) of Virologically Suppressed HIV-1 Infected Adults [Presentation MOPEB0289]. 9th IAS Conference on HIV Science; 2017 23 26 July Paris, France. |
| 28259776 | Result | DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Martorell CT, de Wet J, Stellbrink HJ, Molina JM, Post FA, Valero IP, Porter D, Liu Y, Cheng A, Quirk E, SenGupta D, Cao H. Switching from efavirenz, emtricitabine, and tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e205-e213. doi: 10.1016/S2352-3018(17)30032-2. Epub 2017 Mar 2. |
| Result | Majeed SR, Shao Y, Garner W, Scott J, Pérez-Ruixo C, SenGupta D, et al. Evaluation of RPV/FTC/TAF Exposure-Efficacy and Exposure-Safety Relationships [Poster 427]. Conference on Retroviruses and Opportunistic Infections (CROI) 2017 13-16 February; Seattle, Washington. |
| Result | Hagins D, Mills A, Martorell C, Walmsley S, Gallant J, Tebas P, et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Women [Abstract 12]. 7th International Workshop on HIV & Women; 2017 11-12 February; Seattle, Washington. |
| Result | Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, et al. 48 Week Results from two studies: Switching to RPV/FTC/TAF from EFV/FTC/TDF (Study 1160) or RPV/FTC/TDF (Study 1216) [Presentation]. HIV Glasgow; 2016 23-26 October; Glasgow, United Kingdom. |
| FG001 | EFV/FTC/TDF | Double-Blind Phase: EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks. Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily and attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-Label Extension Phase |
|
|
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FTC/RPV/TAF | FTC/RPV/TAF (200/25/25 mg) FDC tablet + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks. |
| BG001 | EFV/FTC/TDF | EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| HIV-1 RNA Category | Count of Participants | Participants | No |
| |||||||||||||||
| CD4 Cell Count | Mean | Standard Deviation | cells/µL |
| |||||||||||||||
| CD4 Cell Count Category | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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. | The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug and were on EFV/FTC/TDF prior to the screening visit. | Posted | Number | percentage of participants | Week 48 |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm | The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot Algorithm | The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient'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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot | The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient'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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4+ Cell Count at Week 48 | Participants in the Full Analysis Set with on-treatment data were analyzed. | Posted | Mean | Standard Deviation | cells/µL | Baseline; Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4+ Cell Count at Week 96 | Participants in the Full Analysis Set with on-treatment data were analyzed. | Posted | Mean | Standard Deviation | cells/µL | Baseline; Week 96 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. | Participants in the Hip DXA Analysis Set (all randomized participants received at least 1 dose of study drug, and had nonmissing baseline hip BMD value) with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline; Week 48 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Hip BMD at Week 96 | Hip BMD was assessed by DXA scan. | Participants in the Hip DXA Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline; Week 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Spine BMD at Week 48 | Spine BMD was assessed by DXA scan. | Participants in the Spine DXA Analysis Set (all randomized participants, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values) with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline; Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Spine BMD at Week 96 | Spine BMD was assessed by DXA scan. | Participants in the Spine DXA Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percentage change | Baseline; Week 96 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HIV Symptoms Index Score (HIVSI) at Week 48 | The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing. | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline; Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HIVSI Score at Week 96 | The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing. | Participants in the Safety Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline; Week 96 |
|
First dose date to last dose date (maximum duration: 172.4 weeks) plus 30 days
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
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 | FTC/RPV/TAF (Double-Blind Phase) | Adverse events reported occurred during the Double-Blind Phase in participants from the FTC/RPV/TAF group, who received FTC/RPV/TAF (200/25/25 mg) FDC tablet plus EFV/FTC/TDF placebo tablet administered orally once daily. | 3 | 438 | 54 | 438 | 277 | 438 |
| EG001 | EFV/FTC/TDF (Double-Blind Phase) | Adverse events reported occurred during the Double-Blind Phase in participants from the EFV/FTC/TDF group, who received EFV/FTC/TDF (600/200/300 mg) FDC tablet plus FTC/RPV/TAF placebo tablet administered orally once daily. | 0 | 437 | 45 | 437 | 270 | 437 |
| EG002 | Open-Label FTC/RPV/TAF From FTC/RPV/TAF | Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the FTC/RPV/TAF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily. | 0 | 25 | 0 | 25 | 13 | 25 |
| EG003 | Open-Label FTC/RPV/TAF From EFV/FTC/TDF | Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the EFV/FTC/TDF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily. | 0 | 21 | 1 | 21 | 9 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Anal stenosis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Bacterial parotitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Cellulitis orbital | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Gastroenteritis shigella | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Scrotal infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Stoma site abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Limb fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Adenosquamous cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Laryngeal papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Non-small cell lung cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Bipolar II disorder | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fanconi syndrome acquired | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Ileostomy closure | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA 21.1 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| ID | Term |
|---|---|
| D000068257 | Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black |
|
| Native Hawaiian or Pacific Islander |
|
| White |
|
| Not Permitted |
|
| Other |
|
| Not Hispanic or Latino |
|
| Not Permitted |
|
| Belgium |
|
| United States |
|
| United Kingdom |
|
| France |
|
| Switzerland |
|
| Germany |
|
| Spain |
|
| ≥ 50 copies/mL |
|
| ≥ 200 to < 350 cells/µL |
|
| ≥ 350 to < 500 cells/µL |
|
| ≥ 500 cells/ µL |
|
A sample size of 400 HIV-1 infected participants per treatment group would provide 95% power to detect a non-inferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and EFV/FTC/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025. |
| Fisher Exact | 0.35 | Superiority |
|
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|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|