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The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically suppressed HIV-1 infected women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B/F/TAF | Experimental | Participants will switch to B/F/TAF FDC and receive treatment for 48 weeks. |
|
| Baseline Regimen | Active Comparator | Participants will remain on their baseline regimen of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF for 48 weeks. |
|
| Extension Phase | Experimental | Following Week 48, participants in countries where B/F/TAF is not available may have the option to receive B/F/TAF for up to 48 additional weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E/C/F/TAF | Drug | 150/150/200/10 mg FDC tablet administered orally once daily with food |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined 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 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. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined 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 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. |
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Key Inclusion Criteria
Medically stable HIV-1 infected women who meet the following criteria:
Completion of the Week 48 open-label extension (OLE) visit or any post Week 48 OLE visits in Gilead-sponsored study GS-US-236-0128, or Completion of the Week 96 visit or any post Week 96 visits in Gilead-sponsored study GS-US-292-0109 or completion of the Week 144 visit or any post Week 144 visits in Gilead sponsored studies GS-US-292-0104 or GS-US-292-0111.
Currently on a stable antiretroviral regimen consisting of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF continuously for ≥ 12 consecutive weeks preceding the Screening visit
Documented plasma HIV-1 RNA levels < 50 copies/mL for ≥ 12 weeks preceding the Screening visit. After reaching HIV-1 RNA < 50 copies/mL, single values of HIV-1 RNA
≥ 50 copies/mL followed by re-suppression to < 50 copies/mL is allowed
HIV-1 RNA <50 copies/mL at screening
Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (≥ 0.83 mL/sec) according to the Cockcroft-Gault formula at the Screening visit
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 |
|---|---|---|---|---|---|---|
| Stamford | Connecticut | 6902 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36912172 | Derived | Avihingsanon A, Chetchotisakd P, Kiertiburanakul S, Ratanasuwan W, Siripassorn K, Supparatpinyo K, Martin H, Wang H, Wong T, Wang HY. Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed Asian adults living with HIV: A pooled analysis from three international phase III randomized trials. HIV Med. 2023 Mar;24(3):290-300. doi: 10.1111/hiv.13386. Epub 2022 Aug 17. | |
| 31609930 |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
18 months after study completion
A secured external environment with username, password, and RSA code.
491 participants were screened.
Participants were enrolled at study sites in the United States, Russian Federation, Thailand, Dominican Republic, and Uganda. The first participant was screened on 19 February 2016. The last study visit occurred on 26 November 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | B/F/TAF | Randomized Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet once daily for at least 48 weeks, without regard to food. Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF (50/200/25 mg) FDC tablet once daily for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized Phase |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | Nov 20, 2015 | Sep 4, 2018 |
Not provided
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| E/C/F/TDF | Drug | 150/150/200/300 mg FDC administered orally once daily with food |
|
|
| ATV | Drug | ATV 300 mg capsules administered orally once daily with food |
|
|
| RTV | Drug | RTV 100 mg tablets administered orally once daily with food |
|
|
| FTC/TDF | Drug | 200/300 mg tablet administered orally once daily with food |
|
|
| B/F/TAF | Drug | 50/200/25 mg FDC tablet administered orally once daily without regard to food |
|
|
| Week 48 |
| Change From Baseline in CD4+ Cell Count at Week 48 | Baseline; Week 48 |
| Washington D.C. |
| District of Columbia |
| 20009 |
| United States |
| Washington D.C. | District of Columbia | 20037 | United States |
| Fort Lauderdale | Florida | 33308 | United States |
| Ft. Pierce | Florida | 34982 | United States |
| Miami | Florida | 33133 | United States |
| Miami | Florida | 33136 | United States |
| Orlando | Florida | 32803-1851 | United States |
| Tampa | Florida | 33607 | United States |
| Tampa | Florida | 33614 | United States |
| West Palm Beach | Florida | 33401 | United States |
| Atlanta | Georgia | 30308 | United States |
| Decatur | Georgia | 30033 | United States |
| Macon | Georgia | 31201 | United States |
| Savannah | Georgia | 31401 | United States |
| Springfield | Massachusetts | 01105 | United States |
| St Louis | Missouri | 63110 | United States |
| Newark | New Jersey | 07102 | United States |
| Great Neck | New York | 11021 | United States |
| The Bronx | New York | 10467 | United States |
| Charlotte | North Carolina | 28207 | United States |
| Durham | North Carolina | 27710 | United States |
| Huntersville | North Carolina | 28078 | United States |
| Bellaire | Texas | 77401 | United States |
| Dallas | Texas | 75208 | United States |
| Dallas | Texas | 75219 | United States |
| Fort Worth | Texas | 76104 | United States |
| Harlingen | Texas | 78550 | United States |
| Houston | Texas | 77004 | United States |
| Santo Domingo | 10514 | Dominican Republic |
| Santo Domingo | Dominican Republic |
| San Juan | 00909-1711 | Puerto Rico |
| Barnaul | 656010 | Russia |
| Irkutsk | 664043 | Russia |
| Khabarovsk | 680031 | Russia |
| Koltsovo | 630559 | Russia |
| Krasnodar | 350015 | Russia |
| Krasnoyarsk | 660049 | Russia |
| Lipetsk | 398043 | Russia |
| Moscow | 105275 | Russia |
| Moscow | 129110 | Russia |
| Nizhny Novgorod | 603950 | Russia |
| Saint Petersburg | 190103 | Russia |
| Saint Petersburg | 191167 | Russia |
| Saint Petersburg | 196645 | Russia |
| Saint-Petersberg | 190020 | Russia |
| Volgograd | 400010 | Russia |
| Voronezh | 394065 | Russia |
| Yekaterinburg | 620102 | Russia |
| Bangkok | 10330 | Thailand |
| Bangkok | 10400 | Thailand |
| Bangkok | 10700 | Thailand |
| Chiang Mai | 50200 | Thailand |
| Khon Kaen | 40002 | Thailand |
| Nonthaburi | 11000 | Thailand |
| Kampala | Uganda |
| Derived |
| Kityo C, Hagins D, Koenig E, Avihingsanon A, Chetchotisakd P, Supparatpinyo K, Gankina N, Pokrovsky V, Voronin E, Stephens JL, DeJesus E, Wang H, Acosta RK, Cao H, Quirk E, Martin H, Makadzange T. Switching to Fixed-Dose Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Virologically Suppressed HIV-1 Infected Women: A Randomized, Open-Label, Multicenter, Active-Controlled, Phase 3, Noninferiority Trial. J Acquir Immune Defic Syndr. 2019 Nov 1;82(3):321-328. doi: 10.1097/QAI.0000000000002137. |
| FG001 | Stay on Baseline Regimen (SBR) | Randomized Phase: Participants remained on their baseline regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) tablet, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) (150/150/200/300 mg) tablet, or atazanavir (ATV) 300 mg capsule + ritonavir (RTV) 100 mg tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) tablet for at least 48 weeks with food. Extension Phase: After Week 48, participants in countries where B/F/TAF was not available were given the option to receive B/F/TAF (50/200/25 mg) FDC tablet once daily for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension Phase |
|
|
The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | B/F/TAF | B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks. |
| BG001 | Stay on Baseline Regimen | Participants remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 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 |
| |||||||||||||||
| Ethnicity (NIH/OMB) | 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 |
| |||||||||||||||
| Prior Antiretroviral (ARV) Regimen | 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 Determined 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 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. | The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Week 48 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined 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 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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Week 48 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD4+ Cell Count at Week 48 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | cells/µL | Baseline; Week 48 |
|
|
First dose date to last dose date (maximum duration: 128.4 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 | B/F/TAF (Randomized Phase) | Adverse events reported occurred during the Randomized Phase in participants from the B/F/TAF group, who received B/F/TAF (50/200/25 mg) FDC tablet once daily without regard to food for 48 weeks. | 0 | 234 | 7 | 234 | 61 | 234 |
| EG001 | Stay on Baseline Regimen (Randomized Phase) | Adverse events reported occurred during the Randomized Phase in participants from the SBR group, who remained on their baseline regimen of E/C/F/TAF (150/150/200/10 mg) tablet, E/C/F/TDF (150/150/200/300 mg) tablet, or ATV 300 mg capsule + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet for 48 weeks. | 0 | 236 | 9 | 236 | 47 | 236 |
| EG002 | Extension Phase B/F/TAF From B/F/TAF | Adverse events reported occurred during the Extension Phase in participants who enrolled into the Extension Phase from the B/F/TAF group and received B/F/TAF (50/200/25 mg) FDC tablet for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first. | 0 | 231 | 8 | 231 | 52 | 231 |
| EG003 | Extension Phase B/F/TAF From Stay on Baseline Regimen | Adverse events reported occurred during the Extension Phase in participants who enrolled into the Extension Phase from the SBR group and received B/F/TAF (50/200/25 mg) FDC tablet for up to 48 additional weeks, or until the product became accessible to participants through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first. | 1 | 228 | 10 | 228 | 41 | 228 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Urachal abnormality | Congenital, familial and genetic disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Salpingo-oophoritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 21.1 | Systematic Assessment |
| |
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 21.1 | Systematic Assessment |
| |
| Retained products of conception | Pregnancy, puerperium and perinatal conditions | MedDRA 21.1 | Systematic Assessment |
| |
| Device issue | Product Issues | MedDRA 21.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Substance use | Social circumstances | MedDRA 21.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | 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 |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system 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 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Jun 30, 2016 | Sep 4, 2018 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Nov 10, 2016 | Sep 4, 2018 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Week 48 Statistical Analysis Plan | Oct 19, 2017 | Sep 4, 2018 | SAP_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Final Statistical Analysis Plan | Dec 21, 2018 | Oct 3, 2019 | SAP_004.pdf |
| ID | Term |
|---|---|
| D000069545 | Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000069446 | Atazanavir Sulfate |
| D019438 | Ritonavir |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
| ID | Term |
|---|---|
| D000069547 | Cobicistat |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| 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 |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011725 | Pyridines |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Adverse Event |
|
| Withdrew Consent |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| White |
|
| Other |
|
| Dominican Republic |
|
| Uganda |
|
| Thailand |
|
| Russia |
|
| ≥ 50 copies/mL |
|
| ≥ 200 to < 350 cells/µL |
|
| ≥ 350 to < 500 cells/µL |
|
| ≥ 500 cells/µL |
|
| E/C/F/TDF |
|
| RTV + ATV + FTC/TDF |
|
A sample size of 470 participants (~235 participants per treatment group) would provide at least 87% power to detect a non-inferiority margin of 4% difference in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the 2 treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level. |
| Fisher Exact | 1.00 | Superiority |
|
|
|
|