HIV Infections
Conditions
Keywords
Transgender women, Bictegravir
Brief summary
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).
Interventions
DRUGB/FTC/TAF
B/FTC/TAF is bictegravir + tenofovir alafenamide + emtricitabine in one pill (single tablet regimen)
DRUGCurrent ART
Current ART is emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent.
Sponsors
Gilead Sciences
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Self-identified transgender woman (TW) * HIV infection * Undetectable HIV viral load (HIV-1 RNA \<50 copies/mL) at screening and for \>/=24 weeks prior to entry. * Current HIV treatment with FTC plus TDF or TAF and a 3rd agent. * No changes in ART in the 12 weeks prior to screening. * Current female hormone therapy use. * Ability and willingness of subject to provide informed consent.
Exclusion criteria
* Current or planned use of prohibited medications (Phenobarbital, Phenytoin, Carbamazepine, Oxcarbazepine, Rifampin, Rifapentine, St. John's Wort, Echinacea, Dofetilide, Cisapride, Atazanavir) * Change or initiation of lipid- and/or glucose-lowering therapy in the 12 weeks prior to entry, or planned need for such therapy during the study period. * Current use of androgen therapy. * Intent to significantly modify diet or exercise habits, or to enroll in a weight loss intervention during the study period. * Anticipated need to initiate or change doses of medications with anti-inflammatory properties within the study period. * Screening laboratory values as follows: (ANC \<500 cells/mm\^3; Hemoglobin \<10 gm/dL; Cr Cl \<30 mL/min (estimated by CKD-Epi equation); AST or ALT \>3x ULN) * Evidence of resistance to any component of the current ART regimen (genotypic or phenotypic) * Current use of bictegravir in another investigational setting * Current use of other investigational agents that the participant could not receive unchanged, if needed, throughout the study period (unless approved by the study team) * Any condition that the study investigator believes would make the candidate unsuitable for participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Maintaining Undetectable HIV-1 RNA | 48 weeks | Number of participants who maintain \<50 copies/mL HIV-1 RNA for 48 weeks |
| Frequency of Adverse Events | 48 weeks | Number of participants who discontinue study drug due to study-drug related adverse events (AEs, includes \>/= Grade 3 lab or clinical events) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fat Mass, Limbs | baseline | Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA) |
| Percentage of Fat Mass (Total) | Baseline | Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA) |
| Percentage of Fat Mass (Trunk) | Baseline | Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA) |
| Percentage of Fat Mass (Limbs) | Baseline | Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA) |
| Lean Mass (Total) | Baseline | lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA) |
| Lean Mass (Limb) | Baseline | lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA) |
| Hepatic Fat Content | Baseline | 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. |
| Total Cholesterol | Baseline | Total cholesterol level |
| High-density Lipoprotein (HDL) Cholesterol Level | Baseline | — |
| Triglycerides | Baseline | Triglyceride level |
| Low-density Lipoprotein (LDL) Cholesterol Level | Baseline | — |
| Fasting Glucose Level | Baseline | Fasting Glucose level |
| Insulin Resistance | Baseline | 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). |
| Oxidized Low-density Lipoprotein (LDL) Level | Baseline | Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood |
| Hepatic Fibrosis as Indicated by Liver Stiffness Measurement | Baseline | 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 |
| Aspartate Aminotransferase (AST) Level | Baseline | — |
| Alanine Transaminase (ALT) Level | Baseline | — |
| Estimated Glomerular Filtration Rate (CKD- Epi Equations) | Baseline | glomerular filtration rate (GFR) level |
| Fat Mass, Total | Baseline | Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA) |
| Level of Endothelin-1 | Baseline | Inflammatory and metabolic biomarkers level |
| Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE) | Baseline | Inflammatory and metabolic biomarkers level |
| Level of Tumor Necrosis Factor Receptor I (TNFRI) | Baseline | Inflammatory and metabolic biomarkers level |
| Level of Tumor Necrosis Factor Receptor II (TNFRII) | Baseline | Inflammatory and metabolic biomarkers level |
| Level of Insulin | Baseline | Inflammatory and metabolic biomarkers level |
| Level of D-dimer | Baseline | Inflammatory and metabolic biomarkers level |
| Level of Tissue Factor | Baseline | Inflammatory and metabolic biomarkers level |
| Level of Soluble CD14 (sCD14) | Baseline | Inflammatory and metabolic biomarkers level |
| Level of Plasminogen Activator Inhibitor (PAI-1) | Baseline | Inflammatory and metabolic biomarkers level |
| Bone Mineral Density (BMD), Femur Total Mean | Baseline | BMD as measured by dual-energy x-ray absorptiometry (DXA) |
| Bone Mineral Density (BMD), AP-spine L1-L4 | Baseline | BMD as measured by dual-energy x-ray absorptiometry (DXA) |
| T-Score AP-spine L1-L4 | Baseline | 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 |
| T-Score Total Body | Baseline | 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 |
| Bone Mineral Density (BMD), Total Body | Baseline | BMD as measured by dual-energy x-ray absorptiometry (DXA) |
| T-Score Femur Total Mean | Baseline | 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 |
| T-Score Femur Neck Mean | Baseline | 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 |
| Bone Mineral Density (BMD), Femur Neck Mean | 48 weeks | BMD as measured by dual-energy x-ray absorptiometry (DXA) |
| Level of Adiponectin | Baseline | Inflammatory and metabolic biomarkers level |
| Fat Mass, Trunk | Baseline | Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA) |
Countries
United States
Participant flow
Pre-assignment details
Of 26 enrolled participants, 21 met inclusion criteria and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 9 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Switch ART | Continue Current ART | Total |
|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 10 | 47 years STANDARD_DEVIATION 3 | 45.85 years STANDARD_DEVIATION 7.85 |
| Race/Ethnicity, Customized Alaskan Native/American Indian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black/African American | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Hispanic/Latina | 7 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized Native Hawaiian/ Pacific/Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 12 participants | 9 participants | 21 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 9 Participants | 21 Participants |
| Sex/Gender, Customized Self-identified transgender women (TW) | 12 Participants | 9 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 9 |
| other Total, other adverse events | 0 / 12 | 0 / 9 |
| serious Total, serious adverse events | 0 / 12 | 0 / 9 |
Outcome results
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)
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Switch ART | Frequency of Adverse Events | 0 Participants |
| Continue Current ART | Frequency of Adverse Events | 0 Participants |
Primary
Frequency of Maintaining Undetectable HIV-1 RNA
Number of participants who maintain \<50 copies/mL HIV-1 RNA for 48 weeks
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Switch ART | Frequency of Maintaining Undetectable HIV-1 RNA | 10 Participants |
| Continue Current ART | Frequency of Maintaining Undetectable HIV-1 RNA | 8 Participants |
Secondary
Alanine Transaminase (ALT) Level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Alanine Transaminase (ALT) Level | 18.50 international units per liter (IU/L) |
| Continue Current ART | Alanine Transaminase (ALT) Level | 18.00 international units per liter (IU/L) |
Secondary
Alanine Transaminase (ALT) Level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Alanine Transaminase (ALT) Level | 17.00 international units per liter (IU/L) |
| Continue Current ART | Alanine Transaminase (ALT) Level | 16.00 international units per liter (IU/L) |
Secondary
Aspartate Aminotransferase (AST) Level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Aspartate Aminotransferase (AST) Level | 20.50 international units per liter (IU/L) |
| Continue Current ART | Aspartate Aminotransferase (AST) Level | 19.00 international units per liter (IU/L) |
Secondary
Aspartate Aminotransferase (AST) Level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Aspartate Aminotransferase (AST) Level | 19.00 international units per liter (IU/L) |
| Continue Current ART | Aspartate Aminotransferase (AST) Level | 20.00 international units per liter (IU/L) |
Secondary
Bone Mineral Density (BMD), AP-spine L1-L4
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Bone Mineral Density (BMD), AP-spine L1-L4 | 1.17 grams per square centimeter |
| Continue Current ART | Bone Mineral Density (BMD), AP-spine L1-L4 | 1.21 grams per square centimeter |
Secondary
Bone Mineral Density (BMD), AP-spine L1-L4
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Bone Mineral Density (BMD), AP-spine L1-L4 | 1.18 grams per square centimeter |
| Continue Current ART | Bone Mineral Density (BMD), AP-spine L1-L4 | 1.24 grams per square centimeter |
Secondary
Bone Mineral Density (BMD), Femur Neck Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Bone Mineral Density (BMD), Femur Neck Mean | 0.98 grams per square centimeter |
| Continue Current ART | Bone Mineral Density (BMD), Femur Neck Mean | 0.95 grams per square centimeter |
Secondary
Bone Mineral Density (BMD), Femur Neck Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Bone Mineral Density (BMD), Femur Neck Mean | 1.00 grams per square centimeter |
| Continue Current ART | Bone Mineral Density (BMD), Femur Neck Mean | 0.99 grams per square centimeter |
Secondary
Bone Mineral Density (BMD), Femur Total Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Bone Mineral Density (BMD), Femur Total Mean | 1.07 grams per square centimeter |
| Continue Current ART | Bone Mineral Density (BMD), Femur Total Mean | 1.03 grams per square centimeter |
Secondary
Bone Mineral Density (BMD), Femur Total Mean
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Bone Mineral Density (BMD), Femur Total Mean | 1.07 grams per square centimeter |
| Continue Current ART | Bone Mineral Density (BMD), Femur Total Mean | 0.98 grams per square centimeter |
Secondary
Bone Mineral Density (BMD), Total Body
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Bone Mineral Density (BMD), Total Body | 1.21 grams per square centimeter |
| Continue Current ART | Bone Mineral Density (BMD), Total Body | 1.21 grams per square centimeter |
Secondary
Bone Mineral Density (BMD), Total Body
BMD as measured by dual-energy x-ray absorptiometry (DXA)
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Bone Mineral Density (BMD), Total Body | 1.22 grams per square centimeter |
| Continue Current ART | Bone Mineral Density (BMD), Total Body | 1.22 grams per square centimeter |
Secondary
Estimated Glomerular Filtration Rate (CKD- Epi Equations)
glomerular filtration rate (GFR) level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Estimated Glomerular Filtration Rate (CKD- Epi Equations) | 102.00 mL/min/1.73m^2 |
| Continue Current ART | Estimated Glomerular Filtration Rate (CKD- Epi Equations) | 118.00 mL/min/1.73m^2 |
Secondary
Estimated Glomerular Filtration Rate (CKD- Epi Equations)
glomerular filtration rate (GFR) level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Estimated Glomerular Filtration Rate (CKD- Epi Equations) | 110.65 mL/min/1.73m^2 |
| Continue Current ART | Estimated Glomerular Filtration Rate (CKD- Epi Equations) | 105.00 mL/min/1.73m^2 |
Secondary
Fasting Glucose Level
Fasting Glucose level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Fasting Glucose Level | 86 milligrams per deciliter (mg/dL) |
| Continue Current ART | Fasting Glucose Level | 95 milligrams per deciliter (mg/dL) |
Secondary
Fasting Glucose Level
Fasting Glucose level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Fasting Glucose Level | 90 milligrams per deciliter (mg/dL) |
| Continue Current ART | Fasting Glucose Level | 92 milligrams per deciliter (mg/dL) |
Secondary
Fat Mass, Limbs
Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Fat Mass, Limbs | 23.59 pounds (lbs) |
| Continue Current ART | Fat Mass, Limbs | 22.50 pounds (lbs) |
Secondary
Fat Mass, Limbs
Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Fat Mass, Limbs | 21.09 pounds (lbs) |
| Continue Current ART | Fat Mass, Limbs | 19.60 pounds (lbs) |
Secondary
Fat Mass, Total
Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Fat Mass, Total | 62.07 pounds (lbs) |
| Continue Current ART | Fat Mass, Total | 71.57 pounds (lbs) |
Secondary
Fat Mass, Total
Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Fat Mass, Total | 53.49 pounds (lbs) |
| Continue Current ART | Fat Mass, Total | 55.41 pounds (lbs) |
Secondary
Fat Mass, Trunk
Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Fat Mass, Trunk | 34.77 pounds (lbs) |
| Continue Current ART | Fat Mass, Trunk | 44.81 pounds (lbs) |
Secondary
Fat Mass, Trunk
Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Fat Mass, Trunk | 30.80 pounds (lbs) |
| Continue Current ART | Fat Mass, Trunk | 42.21 pounds (lbs) |
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.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Hepatic Fat Content | 254 decibel per meter (dB/m) |
| Continue Current ART | Hepatic Fat Content | 301 decibel per meter (dB/m) |
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.
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Hepatic Fat Content | 253 decibel per meter (dB/m) |
| Continue Current ART | Hepatic Fat Content | 256 decibel per meter (dB/m) |
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
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Hepatic Fibrosis as Indicated by Liver Stiffness Measurement | 4.30 kilopascal (kPa) |
| Continue Current ART | Hepatic Fibrosis as Indicated by Liver Stiffness Measurement | 3.90 kilopascal (kPa) |
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
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Hepatic Fibrosis as Indicated by Liver Stiffness Measurement | 4.35 kilopascal (kPa) |
| Continue Current ART | Hepatic Fibrosis as Indicated by Liver Stiffness Measurement | 4.40 kilopascal (kPa) |
Secondary
High-density Lipoprotein (HDL) Cholesterol Level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | High-density Lipoprotein (HDL) Cholesterol Level | 42 milligrams per deciliter (mg/dL) |
| Continue Current ART | High-density Lipoprotein (HDL) Cholesterol Level | 44 milligrams per deciliter (mg/dL) |
Secondary
High-density Lipoprotein (HDL) Cholesterol Level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | High-density Lipoprotein (HDL) Cholesterol Level | 54 milligrams per deciliter (mg/dL) |
| Continue Current ART | High-density Lipoprotein (HDL) Cholesterol Level | 45 milligrams per deciliter (mg/dL) |
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).
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Insulin Resistance | 2.6 index |
| Continue Current ART | Insulin Resistance | 3.5 index |
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).
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Insulin Resistance | 1.8 index |
| Continue Current ART | Insulin Resistance | 3.9 index |
Secondary
Lean Mass (Limb)
lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Lean Mass (Limb) | 49.79 pounds (lbs) |
| Continue Current ART | Lean Mass (Limb) | 50.14 pounds (lbs) |
Secondary
Lean Mass (Limb)
lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Lean Mass (Limb) | 48.59 pounds (lbs) |
| Continue Current ART | Lean Mass (Limb) | 56.34 pounds (lbs) |
Secondary
Lean Mass (Total)
lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Lean Mass (Total) | 110.20 pounds (lbs) |
| Continue Current ART | Lean Mass (Total) | 137.37 pounds (lbs) |
Secondary
Lean Mass (Total)
lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Lean Mass (Total) | 108.74 pounds (lbs) |
| Continue Current ART | Lean Mass (Total) | 124.38 pounds (lbs) |
Secondary
Level of Adiponectin
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Adiponectin | 3120.11 nanograms per milliliter (ng/mL) |
| Continue Current ART | Level of Adiponectin | 3681.10 nanograms per milliliter (ng/mL) |
Secondary
Level of Adiponectin
Inflammatory and metabolic biomarkers level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Adiponectin | 5615.81 nanograms per milliliter (ng/mL) |
| Continue Current ART | Level of Adiponectin | 3472.11 nanograms per milliliter (ng/mL) |
Secondary
Level of D-dimer
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of D-dimer | 278.59 nanograms per milliliter (ng/mL) |
| Continue Current ART | Level of D-dimer | 197.94 nanograms per milliliter (ng/mL) |
Secondary
Level of D-dimer
Inflammatory and metabolic biomarkers level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of D-dimer | 193.76 nanograms per milliliter (ng/mL) |
| Continue Current ART | Level of D-dimer | 195.64 nanograms per milliliter (ng/mL) |
Secondary
Level of Endothelin-1
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Endothelin-1 | 2.56 picograms per milliliter (pg/mL) |
| Continue Current ART | Level of Endothelin-1 | 5.23 picograms per milliliter (pg/mL) |
Secondary
Level of Endothelin-1
Inflammatory and metabolic biomarkers level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Endothelin-1 | 1.31 picograms per milliliter (pg/mL) |
| Continue Current ART | Level of Endothelin-1 | 3.25 picograms per milliliter (pg/mL) |
Secondary
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)
Inflammatory and metabolic biomarkers level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE) | 136583.77 picograms per milliliter (pg/mL) |
| Continue Current ART | Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE) | 103808.57 picograms per milliliter (pg/mL) |
Secondary
Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE)
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE) | 123321.76 picograms per milliliter (pg/mL) |
| Continue Current ART | Level of Extracellular Newly Identified Receptor for Advanced Glycation End-products Binding Protein (EN-RAGE) | 151499.70 picograms per milliliter (pg/mL) |
Secondary
Level of Insulin
Inflammatory and metabolic biomarkers level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Insulin | 77.08 picomoles per liter (pmol/L) |
| Continue Current ART | Level of Insulin | 107.44 picomoles per liter (pmol/L) |
Secondary
Level of Insulin
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Insulin | 52.51 picomoles per liter (pmol/L) |
| Continue Current ART | Level of Insulin | 105.42 picomoles per liter (pmol/L) |
Secondary
Level of Plasminogen Activator Inhibitor (PAI-1)
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Plasminogen Activator Inhibitor (PAI-1) | 245468.27 picograms per milliliter (pg/mL) |
| Continue Current ART | Level of Plasminogen Activator Inhibitor (PAI-1) | 155299.95 picograms per milliliter (pg/mL) |
Secondary
Level of Plasminogen Activator Inhibitor (PAI-1)
Inflammatory and metabolic biomarkers level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Plasminogen Activator Inhibitor (PAI-1) | 154698.40 picograms per milliliter (pg/mL) |
| Continue Current ART | Level of Plasminogen Activator Inhibitor (PAI-1) | 256300.04 picograms per milliliter (pg/mL) |
Secondary
Level of Soluble CD14 (sCD14)
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Soluble CD14 (sCD14) | 1303.36 Nanograms per milliliter |
| Continue Current ART | Level of Soluble CD14 (sCD14) | 1324.06 Nanograms per milliliter |
Secondary
Level of Soluble CD14 (sCD14)
Inflammatory and metabolic biomarkers level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Soluble CD14 (sCD14) | 1369.58 Nanograms per milliliter |
| Continue Current ART | Level of Soluble CD14 (sCD14) | 1447.20 Nanograms per milliliter |
Secondary
Level of Tissue Factor
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Tissue Factor | 37.33 picograms per milliliter (pg/mL) |
| Continue Current ART | Level of Tissue Factor | 44.34 picograms per milliliter (pg/mL) |
Secondary
Level of Tissue Factor
Inflammatory and metabolic biomarkers level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Tissue Factor | 38.16 picograms per milliliter (pg/mL) |
| Continue Current ART | Level of Tissue Factor | 57.73 picograms per milliliter (pg/mL) |
Secondary
Level of Tumor Necrosis Factor Receptor II (TNFRII)
Inflammatory and metabolic biomarkers level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Tumor Necrosis Factor Receptor II (TNFRII) | 2552.35 picograms per milliliter (pg/mL) |
| Continue Current ART | Level of Tumor Necrosis Factor Receptor II (TNFRII) | 2717.57 picograms per milliliter (pg/mL) |
Secondary
Level of Tumor Necrosis Factor Receptor II (TNFRII)
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Tumor Necrosis Factor Receptor II (TNFRII) | 2306.88 picograms per milliliter (pg/mL) |
| Continue Current ART | Level of Tumor Necrosis Factor Receptor II (TNFRII) | 2388.98 picograms per milliliter (pg/mL) |
Secondary
Level of Tumor Necrosis Factor Receptor I (TNFRI)
Inflammatory and metabolic biomarkers level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Tumor Necrosis Factor Receptor I (TNFRI) | 1032.56 picograms per milliliter (pg/mL) |
| Continue Current ART | Level of Tumor Necrosis Factor Receptor I (TNFRI) | 1266.15 picograms per milliliter (pg/mL) |
Secondary
Level of Tumor Necrosis Factor Receptor I (TNFRI)
Inflammatory and metabolic biomarkers level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Level of Tumor Necrosis Factor Receptor I (TNFRI) | 1077.17 picograms per milliliter (pg/mL) |
| Continue Current ART | Level of Tumor Necrosis Factor Receptor I (TNFRI) | 1118.69 picograms per milliliter (pg/mL) |
Secondary
Low-density Lipoprotein (LDL) Cholesterol Level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Low-density Lipoprotein (LDL) Cholesterol Level | 96 milligrams per deciliter (mg/dL) |
| Continue Current ART | Low-density Lipoprotein (LDL) Cholesterol Level | 92 milligrams per deciliter (mg/dL) |
Secondary
Low-density Lipoprotein (LDL) Cholesterol Level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Low-density Lipoprotein (LDL) Cholesterol Level | 98 milligrams per deciliter (mg/dL) |
| Continue Current ART | Low-density Lipoprotein (LDL) Cholesterol Level | 93 milligrams per deciliter (mg/dL) |
Secondary
Oxidized Low-density Lipoprotein (LDL) Level
Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Oxidized Low-density Lipoprotein (LDL) Level | 39859.07 Units per milliliter (U/mL) |
| Continue Current ART | Oxidized Low-density Lipoprotein (LDL) Level | 46282.62 Units per milliliter (U/mL) |
Secondary
Oxidized Low-density Lipoprotein (LDL) Level
Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Oxidized Low-density Lipoprotein (LDL) Level | 44375.63 units per milliliter |
| Continue Current ART | Oxidized Low-density Lipoprotein (LDL) Level | 35476.24 units per milliliter |
Secondary
Percentage of Fat Mass (Limbs)
Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Percentage of Fat Mass (Limbs) | 59.50 percentage of fat mass |
| Continue Current ART | Percentage of Fat Mass (Limbs) | 62.60 percentage of fat mass |
Secondary
Percentage of Fat Mass (Limbs)
Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Percentage of Fat Mass (Limbs) | 57.80 percentage of fat mass |
| Continue Current ART | Percentage of Fat Mass (Limbs) | 47.80 percentage of fat mass |
Secondary
Percentage of Fat Mass (Total)
Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Percentage of Fat Mass (Total) | 33.70 percentage of fat mass |
| Continue Current ART | Percentage of Fat Mass (Total) | 32.00 percentage of fat mass |
Secondary
Percentage of Fat Mass (Total)
Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Percentage of Fat Mass (Total) | 35.70 percentage of fat mass |
| Continue Current ART | Percentage of Fat Mass (Total) | 34.00 percentage of fat mass |
Secondary
Percentage of Fat Mass (Trunk)
Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Percentage of Fat Mass (Trunk) | 40.15 percentage of fat mass |
| Continue Current ART | Percentage of Fat Mass (Trunk) | 38.20 percentage of fat mass |
Secondary
Percentage of Fat Mass (Trunk)
Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Percentage of Fat Mass (Trunk) | 41.90 percentage of fat mass |
| Continue Current ART | Percentage of Fat Mass (Trunk) | 43.30 percentage of fat mass |
Secondary
Total Cholesterol
Total cholesterol level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Total Cholesterol | 167 milligrams per deciliter (mg/dL) |
| Continue Current ART | Total Cholesterol | 162 milligrams per deciliter (mg/dL) |
Secondary
Total Cholesterol
Total cholesterol level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Total Cholesterol | 173 milligrams per deciliter (mg/dL) |
| Continue Current ART | Total Cholesterol | 162 milligrams per deciliter (mg/dL) |
Secondary
Triglycerides
Triglyceride level
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Triglycerides | 112 milligrams per deciliter (mg/dL) |
| Continue Current ART | Triglycerides | 81 milligrams per deciliter (mg/dL) |
Secondary
Triglycerides
Triglyceride level
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | Triglycerides | 167 milligrams per deciliter (mg/dL) |
| Continue Current ART | Triglycerides | 90 milligrams per deciliter (mg/dL) |
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
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | T-Score AP-spine L1-L4 | -0.30 score on a scale |
| Continue Current ART | T-Score AP-spine L1-L4 | 0.15 score on a scale |
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
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | T-Score AP-spine L1-L4 | -0.20 score on a scale |
| Continue Current ART | T-Score AP-spine L1-L4 | -0.10 score on a scale |
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
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | T-Score Femur Neck Mean | -0.60 score on a scale |
| Continue Current ART | T-Score Femur Neck Mean | -0.65 score on a scale |
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
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | T-Score Femur Neck Mean | -0.70 score on a scale |
| Continue Current ART | T-Score Femur Neck Mean | -0.90 score on a scale |
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
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | T-Score Femur Total Mean | -0.10 score on a scale |
| Continue Current ART | T-Score Femur Total Mean | -0.80 score on a scale |
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
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | T-Score Femur Total Mean | -0.20 score on a scale |
| Continue Current ART | T-Score Femur Total Mean | -0.45 score on a scale |
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
Time frame: 48 weeks
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | T-Score Total Body | -0.10 score on a scale |
| Continue Current ART | T-Score Total Body | -0.20 score on a scale |
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
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Switch ART | T-Score Total Body | 0.05 score on a scale |
| Continue Current ART | T-Score Total Body | 0.00 score on a scale |