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Difficulties enrolling participants
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| University of British Columbia | OTHER |
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Atripla (ATP: FTC/TDF/EFV) was the first single pill treatment for HIV and was the most prescribed first-line treatment from approximately 2008 to 2013 for people infected with HIV. However, ATP has not been recommended as a "preferred" treatment for HIV since 2015, due to there now being single pill treatments that work better. There are a lot of people who are still taking ATP and it is working for them. However, it has the potential to cause serious side effects (chronic kidney disease and fractures and serious neurological effects). These side effects are caused by components in ATP (namely the TDF and EFV parts). Also, the efavirenz (EFV) component is not compatible for treatment of Hepatitis C (HCV) - which is often also seen in people who have HIV. For these reasons, there is a need to find a better alternative treatment for these people currently being treated with ATP.
B/F/TAF (bictegravir/FTC/TAF) is an investigational single pill drug treatment drug that contains neither TDF nor EFV. This study is looking at whether changing people to this new drug treatment will continue to suppress their HIV and have fewer side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B/F/TAF | Experimental | B/F/TAF + Atripla Placebo Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks |
|
| Atripla | Active Comparator | Atripla + B/F/TAF Placebo Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B/F/TAF | Drug | B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine Albumin/Creatinine Ratio (UACR) | change in urine albumin/creatinine ratio (UACR) | Baseline and week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| HIV-1 RNA | Number of participants with HIV-1 RNA < 50 copies/mL | Week 48 |
| Efavirenz (EFV) Symptom Scores | change in EFV symptom scores from Pittsburgh Sleep Quality Questionnaire (PSQI) global score. PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The PSQI global score has a possible range of 0-21. Higher scores represent worse sleep quality. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen D Shafran, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2B7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28867497 | Background | Gallant J, Lazzarin A, Mills A, Orkin C, Podzamczer D, Tebas P, Girard PM, Brar I, Daar ES, Wohl D, Rockstroh J, Wei X, Custodio J, White K, Martin H, Cheng A, Quirk E. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2063-2072. doi: 10.1016/S0140-6736(17)32299-7. Epub 2017 Aug 31. | |
| 28867499 |
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| ID | Title | Description |
|---|---|---|
| FG000 | B/F/TAF | B/F/TAF + Atripla Placebo Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks B/F/TAF: B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily Atripla Placebo: Tablet taken orally once daily |
| FG001 | Atripla | Atripla + B/F/TAF Placebo Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks Atripla: Atripla (Efavirenz 600mg/ emtricitabine 200 mg/ tenofovir disoproxil 245 mg) Tablet taken orally once daily B/F/TAF Placebo: Tablet taken orally once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | B/F/TAF | B/F/TAF + Atripla Placebo Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks B/F/TAF: B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily Atripla Placebo: Tablet taken orally once daily |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Urine Albumin/Creatinine Ratio (UACR) | change in urine albumin/creatinine ratio (UACR) | Data was not collected. Study terminated due to difficulties in enrolling participants. | Posted | Baseline and week 48 |
|
Throughout study period of 52 weeks.
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| 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 | B/F/TAF + Atripla Placebo Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks B/F/TAF: B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily Atripla Placebo: Tablet taken orally once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Klebsiella liver abscess | Hepatobiliary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen D. Shafran | University of Alberta | 780-407-6945 | sshafran@ualberta.ca |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 2, 2019 | Oct 15, 2022 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 28, 2018 | Sep 19, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
| D000068257 | Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Atripla | Drug | Atripla (Efavirenz 600mg/ emtricitabine 200 mg/ tenofovir disoproxil 245 mg) Tablet taken orally once daily |
|
| B/F/TAF Placebo | Drug | Tablet taken orally once daily |
|
| Atripla Placebo | Drug | Tablet taken orally once daily |
|
| Baseline and week 4 |
| Urine Protein/Creatinine Ratio (UPCR) | change in urine protein/creatinine ratio (UPCR) | Baseline and week 48 |
| Estimated Glomerular Filtration Rate (eGFR) | change in estimated glomerular filtration rate (eGFR) | Baseline and week 48 |
| Bone Mineral Density (BMD) at the Hip | change in bone mineral density (BMD) at the hip | Baseline and week 48 |
| Bone Mineral Density (BMD) at the Spine | change in bone mineral density (BMD) at the spine | Baseline and week 48 |
| CD4 Lymphocyte Counts | change in CD4 lymphocyte counts | Baseline and week 48 |
| Serum Lipids | change in serum lipids | Baseline and week 48 |
| Adverse Events | number of adverse events | Baseline, week 4, week 12, week 24, week 36, and week 48 |
| Background |
| Sax PE, Pozniak A, Montes ML, Koenig E, DeJesus E, Stellbrink HJ, Antinori A, Workowski K, Slim J, Reynes J, Garner W, Custodio J, White K, SenGupta D, Cheng A, Quirk E. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017 Nov 4;390(10107):2073-2082. doi: 10.1016/S0140-6736(17)32340-1. Epub 2017 Aug 31. |
| Atripla |
Atripla + B/F/TAF Placebo Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks Atripla: Atripla (Efavirenz 600mg/ emtricitabine 200 mg/ tenofovir disoproxil 245 mg) Tablet taken orally once daily B/F/TAF Placebo: Tablet taken orally once daily |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | HIV-1 RNA | Number of participants with HIV-1 RNA < 50 copies/mL | Data was not collected. Study terminated due to difficulties in enrolling participants. | Posted | Week 48 |
|
|
| Secondary | Efavirenz (EFV) Symptom Scores | change in EFV symptom scores from Pittsburgh Sleep Quality Questionnaire (PSQI) global score. PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The PSQI global score has a possible range of 0-21. Higher scores represent worse sleep quality. | Data was not collected. Study terminated due to difficulties in enrolling participants. | Posted | Baseline and week 4 |
|
|
| Secondary | Urine Protein/Creatinine Ratio (UPCR) | change in urine protein/creatinine ratio (UPCR) | Data was not collected. Study terminated due to difficulties in enrolling participants. | Posted | Baseline and week 48 |
|
|
| Secondary | Estimated Glomerular Filtration Rate (eGFR) | change in estimated glomerular filtration rate (eGFR) | Data was not collected. Study terminated due to difficulties in enrolling participants. | Posted | Baseline and week 48 |
|
|
| Secondary | Bone Mineral Density (BMD) at the Hip | change in bone mineral density (BMD) at the hip | Data was not collected. Study terminated due to difficulties in enrolling participants. | Posted | Baseline and week 48 |
|
|
| Secondary | Bone Mineral Density (BMD) at the Spine | change in bone mineral density (BMD) at the spine | Data was not collected. Study terminated due to difficulties in enrolling participants. | Posted | Baseline and week 48 |
|
|
| Secondary | CD4 Lymphocyte Counts | change in CD4 lymphocyte counts | Data was not collected. Study terminated due to difficulties in enrolling participants. | Posted | Baseline and week 48 |
|
|
| Secondary | Serum Lipids | change in serum lipids | Data was not collected. Study terminated due to difficulties in enrolling participants. | Posted | Baseline and week 48 |
|
|
| Secondary | Adverse Events | number of adverse events | Data was not collected. Study terminated due to difficulties in enrolling participants. | Posted | Baseline, week 4, week 12, week 24, week 36, and week 48 |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 8 |
| 14 |
| EG001 | Atripla | Atripla + B/F/TAF Placebo Each pill is taken once daily, (total of 2 tablets) The blinded treatment phase of this study will last for 52 weeks Atripla: Atripla (Efavirenz 600mg/ emtricitabine 200 mg/ tenofovir disoproxil 245 mg) Tablet taken orally once daily B/F/TAF Placebo: Tablet taken orally once daily | 0 | 14 | 1 | 14 | 5 | 14 |
| Fatigue | General disorders | Systematic Assessment |
|
| Back and/or knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Common cold/viral respiratory illness | Infections and infestations | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hemorrhoidectomy | Surgical and medical procedures | Systematic Assessment |
|
| Elevated ALT | Hepatobiliary disorders | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Lichen planus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Total ankle arthroplasty | Surgical and medical procedures | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| 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 |