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Lack of ability to recruit due to COVID-19 pandemic
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The purpose of this study is to determine the safety and tolerability of a new HIV medication, bictegravir plus emtricitabine plus tenofovir alafenamide (B/FTC/TAF, 3 HIV medications combined into one pill) in HIV-infected transgender women (TW).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Switch ART | Experimental | Switch from current antiretroviral therapy (ART) to bictegravir + tenofovir alafenamide + emtricitabine (B/FTC/TAF) for 48 weeks |
|
| Continue Current ART | Active Comparator | Continue current antiretroviral therapy (ART) therapy (which is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B/FTC/TAF | Drug | B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Maintaining Undetectable HIV-1 RNA | Number of participants who maintain <50 copies/mL HIV-1 RNA for 48 weeks | 48 weeks |
| Frequency of Adverse Events | Number of participants who discontinue study drug due to study-drug related adverse events (AEs, includes >/= Grade 3 lab or clinical events) | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fat Mass, Total | Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA) | Baseline |
| Fat Mass, Total | Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA) |
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Inclusion Criteria:
Exclusion Criteria:
Self-identified transgender women (TW)
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| Name | Affiliation | Role |
|---|---|---|
| Jordan E Lake, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Street Health Center | Houston | Texas | 77009 | United States |
Of 26 enrolled participants, 21 met inclusion criteria and were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Switch ART | Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A. |
| FG001 | Continue Current ART | Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Switch ART | Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A. |
| BG001 | Continue Current ART |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Frequency of Maintaining Undetectable HIV-1 RNA | Number of participants who maintain <50 copies/mL HIV-1 RNA for 48 weeks | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Count of Participants | Participants | 48 weeks |
|
48 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 | Switch ART | Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan Elizabeth Lake, MD, Associate Professor | The University of Texas Health Science Center at Houston | (713) 500-6759 | Jordan.E.Lake@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2019 | Aug 31, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Current ART | Drug | Current ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent. |
|
| 48 weeks |
| Fat Mass, Trunk | Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA) | Baseline |
| Fat Mass, Trunk | Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA) | 48 weeks |
| Fat Mass, Limbs | Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA) | baseline |
| Fat Mass, Limbs | Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA) | 48 weeks |
| Percentage of Fat Mass (Total) | Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA) | Baseline |
| Percentage of Fat Mass (Total) | Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA) | 48 weeks |
| Percentage of Fat Mass (Trunk) | Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA) | Baseline |
| Percentage of Fat Mass (Trunk) | Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA) | 48 weeks |
| Percentage of Fat Mass (Limbs) | Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA) | Baseline |
| Percentage of Fat Mass (Limbs) | Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA) | 48 weeks |
| Lean Mass (Total) | lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA) | Baseline |
| Lean Mass (Limb) | lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA) | Baseline |
| Lean Mass (Total) | lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA) | 48 weeks |
| Lean Mass (Limb) | lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA) | 48 weeks |
| Hepatic Fat Content | The controlled attenuation parameter (CAP) indicates quantity of fat in the liver (that is, hepatic fat content). CAP is assessed by performing transient elastography (TE) using a FibroScan device, which uses ultrasound. The CAP score is measured in decibels per meter (dB/m). CAP score ranges from 100 dB/m to 400 dB/m, and a higher score indicates greater hepatic fat content. | Baseline |
| Hepatic Fat Content | The controlled attenuation parameter (CAP) indicates quantity of fat in the liver (that is, hepatic fat content). CAP is assessed by performing transient elastography (TE) using a FibroScan device, which uses ultrasound. The CAP score is measured in decibels per meter (dB/m). CAP score ranges from 100 dB/m to 400 dB/m, and a higher score indicates greater hepatic fat content. | 48 weeks |
| Total Cholesterol | Total cholesterol level | Baseline |
| Total Cholesterol | Total cholesterol level | 48 weeks |
| High-density Lipoprotein (HDL) Cholesterol Level | Baseline |
| High-density Lipoprotein (HDL) Cholesterol Level | 48 weeks |
| Triglycerides | Triglyceride level | Baseline |
| Triglycerides | Triglyceride level | 48 weeks |
| Low-density Lipoprotein (LDL) Cholesterol Level | Baseline |
| Low-density Lipoprotein (LDL) Cholesterol Level | 48 weeks |
| Fasting Glucose Level | Fasting Glucose level | Baseline |
| Fasting Glucose Level | Fasting Glucose level | 48 weeks |
| Insulin Resistance | The Homeostatic Assessment Model of Insulin Resistance (HOMA-IR) is an index used to determine if insulin resistance is present. HOMA-IR is calculated as ([(fasting insulin in mU/L) x (glucose in mmol/L)]/22.5). Higher HOMA-IR values indicate greater insulin resistance. The threshold HOMA-IR value that indicates insulin resistance differs among different populations, but a common clinical cutoff is 2.6 (in other words, a HOMA-IR value of 2.6 or above is commonly interpreted to indicate insulin resistance). | Baseline |
| Insulin Resistance | The Homeostatic Assessment Model of Insulin Resistance (HOMA-IR) is an index used to determine if insulin resistance is present. HOMA-IR is calculated as ([(fasting insulin in mU/L) x (glucose in mmol/L)]/22.5). Higher HOMA-IR values indicate greater insulin resistance. The threshold HOMA-IR value that indicates insulin resistance differs among different populations, but a common clinical cutoff is 2.6 (in other words, a HOMA-IR value of 2.6 or above is commonly interpreted to indicate insulin resistance). | 48 weeks |
| Oxidized Low-density Lipoprotein (LDL) Level | Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood | Baseline |
| Oxidized Low-density Lipoprotein (LDL) Level | Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood | 48 weeks |
| Hepatic Fibrosis as Indicated by Liver Stiffness Measurement | Fibrosis (that is, scarring of the liver) results in liver stiffness, and liver stiffness can be measured by liver elastography using a FibroScan device, which uses ultrasound. The liver stiffness measurement ranges from 2 kPa to 75 kPa, with a higher score indicating greater liver scarring and stiffness | Baseline |
| Hepatic Fibrosis as Indicated by Liver Stiffness Measurement | Fibrosis (that is, scarring of the liver) results in liver stiffness, and liver stiffness can be measured by liver elastography using a FibroScan device, which uses ultrasound. The liver stiffness measurement ranges from 2 kPa to 75 kPa, with a higher score indicating greater liver scarring and stiffness | 48 weeks |
| Aspartate Aminotransferase (AST) Level | Baseline |
| Aspartate Aminotransferase (AST) Level | 48 weeks |
| Alanine Transaminase (ALT) Level | Baseline |
| Alanine Transaminase (ALT) Level | 48 weeks |
| Estimated Glomerular Filtration Rate (CKD- Epi Equations) | glomerular filtration rate (GFR) level | Baseline |
| Estimated Glomerular Filtration Rate (CKD- Epi Equations) | glomerular filtration rate (GFR) level | 48 weeks |
| Level of Adiponectin | Inflammatory and metabolic biomarkers level | Baseline |
| Level of Adiponectin | Inflammatory and metabolic biomarkers level | 48 weeks |
| Level of Endothelin-1 | Inflammatory and metabolic biomarkers level | Baseline |
| Level of Endothelin-1 | Inflammatory and metabolic biomarkers level | 48 weeks |
| Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE) | Inflammatory and metabolic biomarkers level | Baseline |
| Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE) | Inflammatory and metabolic biomarkers level | 48 weeks |
| Level of Tumor Necrosis Factor Receptor I (TNFRI) | Inflammatory and metabolic biomarkers level | Baseline |
| Level of Tumor Necrosis Factor Receptor I (TNFRI) | Inflammatory and metabolic biomarkers level | 48 weeks |
| Level of Tumor Necrosis Factor Receptor II (TNFRII) | Inflammatory and metabolic biomarkers level | Baseline |
| Level of Tumor Necrosis Factor Receptor II (TNFRII) | Inflammatory and metabolic biomarkers level | 48 weeks |
| Level of Insulin | Inflammatory and metabolic biomarkers level | Baseline |
| Level of Insulin | Inflammatory and metabolic biomarkers level | 48 weeks |
| Level of D-dimer | Inflammatory and metabolic biomarkers level | Baseline |
| Level of D-dimer | Inflammatory and metabolic biomarkers level | 48 weeks |
| Level of Tissue Factor | Inflammatory and metabolic biomarkers level | Baseline |
| Level of Tissue Factor | Inflammatory and metabolic biomarkers level | 48 weeks |
| Level of Soluble CD14 (sCD14) | Inflammatory and metabolic biomarkers level | Baseline |
| Level of Soluble CD14 (sCD14) | Inflammatory and metabolic biomarkers level | 48 weeks |
| Level of Plasminogen Activator Inhibitor (PAI-1) | Inflammatory and metabolic biomarkers level | Baseline |
| Level of Plasminogen Activator Inhibitor (PAI-1) | Inflammatory and metabolic biomarkers level | 48 weeks |
| Bone Mineral Density (BMD), Femur Total Mean | BMD as measured by dual-energy x-ray absorptiometry (DXA) | Baseline |
| Bone Mineral Density (BMD), Femur Total Mean | BMD as measured by dual-energy x-ray absorptiometry (DXA) | 48 weeks |
| Bone Mineral Density (BMD), AP-spine L1-L4 | BMD as measured by dual-energy x-ray absorptiometry (DXA) | Baseline |
| Bone Mineral Density (BMD), AP-spine L1-L4 | BMD as measured by dual-energy x-ray absorptiometry (DXA) | 48 weeks |
| T-Score AP-spine L1-L4 | Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | Baseline |
| T-Score AP-spine L1-L4 | Bone mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | 48 weeks |
| T-Score Total Body | Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | Baseline |
| T-Score Total Body | Bone mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | 48 weeks |
| Bone Mineral Density (BMD), Total Body | BMD as measured by dual-energy x-ray absorptiometry (DXA) | Baseline |
| T-Score Femur Total Mean | Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | Baseline |
| T-Score Femur Total Mean | Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | 48 weeks |
| T-Score Femur Neck Mean | Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | Baseline |
| T-Score Femur Neck Mean | Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | 48 weeks |
| Bone Mineral Density (BMD), Femur Neck Mean | BMD as measured by dual-energy x-ray absorptiometry (DXA) | 48 weeks |
| Bone Mineral Density (BMD), Femur Neck Mean | BMD as measured by dual-energy x-ray absorptiometry (DXA) | Baseline |
| Bone Mineral Density (BMD), Total Body | BMD as measured by dual-energy x-ray absorptiometry (DXA) | 48 weeks |
Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks
Current ART: Comparator arm. Participant continues open label entry ART.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Continue Current ART |
Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART. |
|
|
| Primary | Frequency of Adverse Events | Number of participants who discontinue study drug due to study-drug related adverse events (AEs, includes >/= Grade 3 lab or clinical events) | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Count of Participants | Participants | 48 weeks |
|
|
|
| Secondary | Fat Mass, Total | Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA) | Posted | Median | Inter-Quartile Range | pounds (lbs) | Baseline |
|
|
|
| Secondary | Fat Mass, Total | Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA) | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | pounds (lbs) | 48 weeks |
|
|
|
| Secondary | Fat Mass, Trunk | Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA) | Posted | Median | Inter-Quartile Range | pounds (lbs) | Baseline |
|
|
|
| Secondary | Fat Mass, Trunk | Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA) | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | pounds (lbs) | 48 weeks |
|
|
|
| Secondary | Fat Mass, Limbs | Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA) | Posted | Median | Inter-Quartile Range | pounds (lbs) | baseline |
|
|
|
| Secondary | Fat Mass, Limbs | Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA) | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | pounds (lbs) | 48 weeks |
|
|
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| Secondary | Percentage of Fat Mass (Total) | Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA) | Posted | Median | Inter-Quartile Range | percentage of fat mass | Baseline |
|
|
|
| Secondary | Percentage of Fat Mass (Total) | Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA) | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | percentage of fat mass | 48 weeks |
|
|
|
| Secondary | Percentage of Fat Mass (Trunk) | Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA) | Posted | Median | Inter-Quartile Range | percentage of fat mass | Baseline |
|
|
|
| Secondary | Percentage of Fat Mass (Trunk) | Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA) | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | percentage of fat mass | 48 weeks |
|
|
|
| Secondary | Percentage of Fat Mass (Limbs) | Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA) | Posted | Median | Inter-Quartile Range | percentage of fat mass | Baseline |
|
|
|
| Secondary | Percentage of Fat Mass (Limbs) | Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA) | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | percentage of fat mass | 48 weeks |
|
|
|
| Secondary | Lean Mass (Total) | lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA) | Posted | Median | Inter-Quartile Range | pounds (lbs) | Baseline |
|
|
|
| Secondary | Lean Mass (Limb) | lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA) | Posted | Median | Inter-Quartile Range | pounds (lbs) | Baseline |
|
|
|
| Secondary | Lean Mass (Total) | lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA) | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | pounds (lbs) | 48 weeks |
|
|
|
| Secondary | Lean Mass (Limb) | lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA) | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | pounds (lbs) | 48 weeks |
|
|
|
| Secondary | Hepatic Fat Content | The controlled attenuation parameter (CAP) indicates quantity of fat in the liver (that is, hepatic fat content). CAP is assessed by performing transient elastography (TE) using a FibroScan device, which uses ultrasound. The CAP score is measured in decibels per meter (dB/m). CAP score ranges from 100 dB/m to 400 dB/m, and a higher score indicates greater hepatic fat content. | Posted | Median | Inter-Quartile Range | decibel per meter (dB/m) | Baseline |
|
|
|
| Secondary | Hepatic Fat Content | The controlled attenuation parameter (CAP) indicates quantity of fat in the liver (that is, hepatic fat content). CAP is assessed by performing transient elastography (TE) using a FibroScan device, which uses ultrasound. The CAP score is measured in decibels per meter (dB/m). CAP score ranges from 100 dB/m to 400 dB/m, and a higher score indicates greater hepatic fat content. | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | decibel per meter (dB/m) | 48 weeks |
|
|
|
| Secondary | Total Cholesterol | Total cholesterol level | Posted | Median | Inter-Quartile Range | milligrams per deciliter (mg/dL) | Baseline |
|
|
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| Secondary | Total Cholesterol | Total cholesterol level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | milligrams per deciliter (mg/dL) | 48 weeks |
|
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| Secondary | High-density Lipoprotein (HDL) Cholesterol Level | Posted | Median | Inter-Quartile Range | milligrams per deciliter (mg/dL) | Baseline |
|
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| Secondary | High-density Lipoprotein (HDL) Cholesterol Level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | milligrams per deciliter (mg/dL) | 48 weeks |
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| Secondary | Triglycerides | Triglyceride level | Posted | Median | Inter-Quartile Range | milligrams per deciliter (mg/dL) | Baseline |
|
|
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| Secondary | Triglycerides | Triglyceride level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | milligrams per deciliter (mg/dL) | 48 weeks |
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| Secondary | Low-density Lipoprotein (LDL) Cholesterol Level | Posted | Median | Inter-Quartile Range | milligrams per deciliter (mg/dL) | Baseline |
|
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|
| Secondary | Low-density Lipoprotein (LDL) Cholesterol Level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | milligrams per deciliter (mg/dL) | 48 weeks |
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| Secondary | Fasting Glucose Level | Fasting Glucose level | Posted | Median | Inter-Quartile Range | milligrams per deciliter (mg/dL) | Baseline |
|
|
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| Secondary | Fasting Glucose Level | Fasting Glucose level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | milligrams per deciliter (mg/dL) | 48 weeks |
|
|
|
| Secondary | Insulin Resistance | The Homeostatic Assessment Model of Insulin Resistance (HOMA-IR) is an index used to determine if insulin resistance is present. HOMA-IR is calculated as ([(fasting insulin in mU/L) x (glucose in mmol/L)]/22.5). Higher HOMA-IR values indicate greater insulin resistance. The threshold HOMA-IR value that indicates insulin resistance differs among different populations, but a common clinical cutoff is 2.6 (in other words, a HOMA-IR value of 2.6 or above is commonly interpreted to indicate insulin resistance). | Posted | Median | Inter-Quartile Range | index | Baseline |
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| Secondary | Insulin Resistance | The Homeostatic Assessment Model of Insulin Resistance (HOMA-IR) is an index used to determine if insulin resistance is present. HOMA-IR is calculated as ([(fasting insulin in mU/L) x (glucose in mmol/L)]/22.5). Higher HOMA-IR values indicate greater insulin resistance. The threshold HOMA-IR value that indicates insulin resistance differs among different populations, but a common clinical cutoff is 2.6 (in other words, a HOMA-IR value of 2.6 or above is commonly interpreted to indicate insulin resistance). | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | index | 48 weeks |
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| Secondary | Oxidized Low-density Lipoprotein (LDL) Level | Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood | Posted | Median | Inter-Quartile Range | Units per milliliter (U/mL) | Baseline |
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| Secondary | Oxidized Low-density Lipoprotein (LDL) Level | Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | units per milliliter | 48 weeks |
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| Secondary | Hepatic Fibrosis as Indicated by Liver Stiffness Measurement | Fibrosis (that is, scarring of the liver) results in liver stiffness, and liver stiffness can be measured by liver elastography using a FibroScan device, which uses ultrasound. The liver stiffness measurement ranges from 2 kPa to 75 kPa, with a higher score indicating greater liver scarring and stiffness | Posted | Median | Inter-Quartile Range | kilopascal (kPa) | Baseline |
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| Secondary | Hepatic Fibrosis as Indicated by Liver Stiffness Measurement | Fibrosis (that is, scarring of the liver) results in liver stiffness, and liver stiffness can be measured by liver elastography using a FibroScan device, which uses ultrasound. The liver stiffness measurement ranges from 2 kPa to 75 kPa, with a higher score indicating greater liver scarring and stiffness | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | kilopascal (kPa) | 48 weeks |
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| Secondary | Aspartate Aminotransferase (AST) Level | Posted | Median | Inter-Quartile Range | international units per liter (IU/L) | Baseline |
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| Secondary | Aspartate Aminotransferase (AST) Level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | international units per liter (IU/L) | 48 weeks |
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| Secondary | Alanine Transaminase (ALT) Level | Posted | Median | Inter-Quartile Range | international units per liter (IU/L) | Baseline |
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| Secondary | Alanine Transaminase (ALT) Level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | international units per liter (IU/L) | 48 weeks |
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| Secondary | Estimated Glomerular Filtration Rate (CKD- Epi Equations) | glomerular filtration rate (GFR) level | Posted | Median | Inter-Quartile Range | mL/min/1.73m^2 | Baseline |
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| Secondary | Estimated Glomerular Filtration Rate (CKD- Epi Equations) | glomerular filtration rate (GFR) level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | mL/min/1.73m^2 | 48 weeks |
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| Secondary | Level of Adiponectin | Inflammatory and metabolic biomarkers level | Posted | Median | Inter-Quartile Range | nanograms per milliliter (ng/mL) | Baseline |
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| Secondary | Level of Adiponectin | Inflammatory and metabolic biomarkers level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | nanograms per milliliter (ng/mL) | 48 weeks |
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| Secondary | Level of Endothelin-1 | Inflammatory and metabolic biomarkers level | Posted | Median | Inter-Quartile Range | picograms per milliliter (pg/mL) | Baseline |
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| Secondary | Level of Endothelin-1 | Inflammatory and metabolic biomarkers level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | picograms per milliliter (pg/mL) | 48 weeks |
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| Secondary | Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE) | Inflammatory and metabolic biomarkers level | Posted | Median | Inter-Quartile Range | picograms per milliliter (pg/mL) | Baseline |
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| Secondary | Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE) | Inflammatory and metabolic biomarkers level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | picograms per milliliter (pg/mL) | 48 weeks |
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| Secondary | Level of Tumor Necrosis Factor Receptor I (TNFRI) | Inflammatory and metabolic biomarkers level | Posted | Median | Inter-Quartile Range | picograms per milliliter (pg/mL) | Baseline |
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| Secondary | Level of Tumor Necrosis Factor Receptor I (TNFRI) | Inflammatory and metabolic biomarkers level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | picograms per milliliter (pg/mL) | 48 weeks |
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| Secondary | Level of Tumor Necrosis Factor Receptor II (TNFRII) | Inflammatory and metabolic biomarkers level | Posted | Median | Inter-Quartile Range | picograms per milliliter (pg/mL) | Baseline |
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| Secondary | Level of Tumor Necrosis Factor Receptor II (TNFRII) | Inflammatory and metabolic biomarkers level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | picograms per milliliter (pg/mL) | 48 weeks |
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| Secondary | Level of Insulin | Inflammatory and metabolic biomarkers level | Posted | Median | Inter-Quartile Range | picomoles per liter (pmol/L) | Baseline |
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| Secondary | Level of Insulin | Inflammatory and metabolic biomarkers level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | picomoles per liter (pmol/L) | 48 weeks |
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| Secondary | Level of D-dimer | Inflammatory and metabolic biomarkers level | Posted | Median | Inter-Quartile Range | nanograms per milliliter (ng/mL) | Baseline |
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| Secondary | Level of D-dimer | Inflammatory and metabolic biomarkers level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | nanograms per milliliter (ng/mL) | 48 weeks |
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| Secondary | Level of Tissue Factor | Inflammatory and metabolic biomarkers level | Posted | Median | Inter-Quartile Range | picograms per milliliter (pg/mL) | Baseline |
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| Secondary | Level of Tissue Factor | Inflammatory and metabolic biomarkers level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | picograms per milliliter (pg/mL) | 48 weeks |
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| Secondary | Level of Soluble CD14 (sCD14) | Inflammatory and metabolic biomarkers level | Posted | Median | Inter-Quartile Range | Nanograms per milliliter | Baseline |
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| Secondary | Level of Soluble CD14 (sCD14) | Inflammatory and metabolic biomarkers level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | Nanograms per milliliter | 48 weeks |
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| Secondary | Level of Plasminogen Activator Inhibitor (PAI-1) | Inflammatory and metabolic biomarkers level | Posted | Median | Inter-Quartile Range | picograms per milliliter (pg/mL) | Baseline |
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| Secondary | Level of Plasminogen Activator Inhibitor (PAI-1) | Inflammatory and metabolic biomarkers level | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | picograms per milliliter (pg/mL) | 48 weeks |
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| Secondary | Bone Mineral Density (BMD), Femur Total Mean | BMD as measured by dual-energy x-ray absorptiometry (DXA) | Posted | Median | Inter-Quartile Range | grams per square centimeter | Baseline |
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| Secondary | Bone Mineral Density (BMD), Femur Total Mean | BMD as measured by dual-energy x-ray absorptiometry (DXA) | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | grams per square centimeter | 48 weeks |
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| Secondary | Bone Mineral Density (BMD), AP-spine L1-L4 | BMD as measured by dual-energy x-ray absorptiometry (DXA) | Posted | Median | Inter-Quartile Range | grams per square centimeter | Baseline |
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| Secondary | Bone Mineral Density (BMD), AP-spine L1-L4 | BMD as measured by dual-energy x-ray absorptiometry (DXA) | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | grams per square centimeter | 48 weeks |
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| Secondary | T-Score AP-spine L1-L4 | Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
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| Secondary | T-Score AP-spine L1-L4 | Bone mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | score on a scale | 48 weeks |
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| Secondary | T-Score Total Body | Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
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| Secondary | T-Score Total Body | Bone mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | score on a scale | 48 weeks |
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| Secondary | Bone Mineral Density (BMD), Total Body | BMD as measured by dual-energy x-ray absorptiometry (DXA) | Posted | Median | Inter-Quartile Range | grams per square centimeter | Baseline |
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| Secondary | T-Score Femur Total Mean | Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
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| Secondary | T-Score Femur Total Mean | Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | score on a scale | 48 weeks |
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| Secondary | T-Score Femur Neck Mean | Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
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| Secondary | T-Score Femur Neck Mean | Bone Mineral Density T-score as measured by dual-energy x-ray absorptiometry (DXA) A T-score between +1 and -1 is considered normal or healthy. A T-score between -1 and -2.5 indicates osteopenia. A T-score of -2.5 or lower indicates osteoporosis | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | score on a scale | 48 weeks |
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| Secondary | Bone Mineral Density (BMD), Femur Neck Mean | BMD as measured by dual-energy x-ray absorptiometry (DXA) | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | grams per square centimeter | 48 weeks |
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| Secondary | Bone Mineral Density (BMD), Femur Neck Mean | BMD as measured by dual-energy x-ray absorptiometry (DXA) | Posted | Median | Inter-Quartile Range | grams per square centimeter | Baseline |
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| Secondary | Bone Mineral Density (BMD), Total Body | BMD as measured by dual-energy x-ray absorptiometry (DXA) | Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint. | Posted | Median | Inter-Quartile Range | grams per square centimeter | 48 weeks |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Continue Current ART | Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART. | 0 | 9 | 0 | 9 | 0 | 9 |
Not provided
Not provided
Not provided
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |