HIV Infections
Conditions
Keywords
tenofovir disoproxil fumarate, dolutegravir plus rilpivirine, two-drug regimen, bone mineral density, dual energy X-ray absorptiometry (DEXA), Human Immunodeficiency Virus-1, nucleoside reverse transcriptase inhibitor -sparing regimen, integrase inhibitor
Brief summary
The purpose of this study is to evaluate any change from baseline in bone mineral density (BMD) in subjects following the switch from a triple antiretroviral therapy (ART) regimen containing Tenofovir disoproxil fumarate (TDF) to the nucleoside reverse transcriptase inhibitor (NRTI) - sparing two - drug regimen of dolutegravir (DTG) + rilpivirine (RPV) in subjects participating in the parent studies 201636 and 201637 (SWORD-1 and SWORD-2). This open-label, parallel group, study is a sub-study which will recruit subjects who are receiving ART regimens which include TDF at the time of randomization to receive treatment in one of two identical parent studies 201636 and 201637 (SWORD-1 and SWORD-2). These are Phase III, randomised, open-label, multicentre, parallel-group, non-inferiority studies evaluating the efficacy, safety, and tolerability of switching to DTG plus RPV from current integrase inhibitor (INI)-, non NNRTI-, or protease inhibitor (PI)-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed, having HIV-1 ribonucleic acid (RNA) levels \<50 copies per millilitre (c/mL). Randomisation in the parent studies will be stratified by baseline third agent class (INI, NNRTI, or PI), age group (\< or =\>50 years old) and participation in this Dual energy X-ray absorptiometry (DEXA) sub-study, therefore there will also be balance across the treatment arms in this sub-study both overall and with respect to baseline third agent class and age at entry. The study population will include approximately 75 evaluable subjects recruited from the Early Switch DTG + RPV treatment group of the parent studies 201636 and 201637, and approximately 75 evaluable subjects from the Late Switch group who continue their current antiretroviral therapy (CAR) through to Week 52 across both the 201636 and 201637 (SWORD-1 and SWORD-2) studies. Subjects participating in study 202094 will have DEXA scans performed at Day 1 and at study Weeks 48, 100 and 148 in parallel with the corresponding scheduled visits in the parent studies.
Interventions
DRUGSubjects do not receive study medication in this study 202094
Participants do not receive study medication in this study 202094.
Sponsors
Janssen Pharmaceuticals
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Screened and eligible but not yet randomised to either of the parent studies 201636 (SWORD-1) or 201637 (SWORD-2) * Receiving an ART regimen which contains TDF * Female subjects of child bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the methods of contraception described in the protocols of the parent studies 201636 (SWORD-1) and 201637 (SWORD-2) to avoid pregnancy. Any contraception method must be used consistently, throughout the study period in accordance with the approved product label, including adherence to appropriate 'run in' periods for hormonal contraception * Subject is willing and able to understand the requirements of study participation and provide signed and dated written informed consent prior to Screening. Subject is considered an appropriate candidate for participation in this study * For subjects enrolled in France: a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
Exclusion criteria
* Less than three vertebra in the range of L1 to L4 that are suitable for BMD measurement by DEXA scan * Bilateral hip replacement * Uncontrolled thyroid disease: thyroid stimulating hormone (TSH) above normal range, and considered to indicate a requirement for thyroid replacement therapy * Male hypogonadism: serum testosterone \< 300 nanogram per decilitre (ng/dL) on a sample collected before 10:00 in the morning and the subject is able and willing to start testosterone replacement therapy * Endocrine diseases including Cushing's syndrome and diabetes mellitus * History of fragility fractures * Ever treated for osteoporosis with bisphosphonates, oestrogen receptor modulators or other therapies, and / or severe osteoporosis as indicated by a prior DEXA scan derived T-score of -3.5 or lower value * Body mass index (BMI) \< 18 kilogram per meter (kg/m)\^2 or =\>40 kg/m\^2 * Vitamin D deficiency: 25 Hydroxy Vitamin D \< 15ng/mL * Any pre-existing physical or mental condition (including substance abuse disorder) which, in the opinion of the investigator, may interfere with the subject's ability to comply with the scheduled protocol evaluations or which may compromise the safety of the subject * Current use or intent to initiate, tamoxifen, bone-related treatment, e.g. biphosphonates, osteoporosis medications including selective oestrogen receptor modulator medicines (raloxifene, arzoxifene and lasofoxifene), growth hormone or anabolic steroids, except for testosterone as specified below, during the study period * The following are excluded unless they have been given for at least 6 months prior to Day 1, and there is no plan to stop them during the study: Anti-convulsant therapy and hormonal therapy, including female hormone replacement therapy or testosterone as a replacement therapy or supplement * Women who are pregnant, breastfeeding or who plan to become pregnant or breast feed during the study period * Subject enrolled, or anticipated to be selected to participate following study registration, in an investigational clinical protocol/s in addition to one of the parent studies 201636 or 201637 (SWORD-1 or SWORD-2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 48 | Baseline (Day 1) and Week 48 | Percent change in BMD (expressed as areal density in grams per centimeter square \[g/cm\^2\]) as specified by dual energy X-ray absorptiometry (DEXA) scans of the left 'total hip' which included the femoral neck, trochanter and inter-trochanter areas was assessed by areal density at Baseline and Week 48. The estimated value in the statistical analysis is this difference and the upper and lower limit values shown are the 95% confidence intervals. Baseline was considered as Day 1 and percent change from Baseline was calculated as Value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An analysis of covariance (ANCOVA) model was used to compare the difference. The analysis was performed on Intent-to-Treat exposed DEXA (ITT-ED) Population which comprised of all participants in the ITT-E Population who received at least one dose of study treatment, and who were registered for the 202094 study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Baseline (Day 1), Week 48, Week 100 and Week 148 | Percent change in BMD (expressed as areal density in g/cm\^2) as specified by DEXA scans of left 'total hip' which included femoral neck, trochanter and inter-trochanter areas and 'lumbar spine' which included L1 to L4 was assessed by areal density. Percent change from Baseline is post-dose value minus Baseline value divided by Baseline value multiplied by 100. BMD parameters at Weeks 48, 100 and 148 reflect data adjusted following the ongoing longitudinal and cross-calibration of multiple DEXA scanner instruments in this study. Data presented through Week 48 only represent results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations though Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses. |
| Percent Change From Late Switch (LS) Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD-CAR Late Switch Group Through Late Switch Phase | LS Baseline (Week 48), Week 100 and Week 148 | Percent change in BMD (expressed as areal density in g/cm\^2) as specified by DEXA scans of the left 'total hip' which included the femoral neck, trochanter and inter-trochanter areas was assessed by areal density at indicated time points. Percent change in BMD as specified by DEXA scans of the 'lumbar spine' which included the first lumbar vertebra (L1) to the fourth lumbar vertebra (L4) was assessed by areal density at indicated time points. The last pre-switch value (Week 48) was considered as LS Baseline and percent change from LS Baseline was calculated as post-dose visit value minus LS Baseline value divided by LS Baseline value multiplied by 100. The analysis was based on Late-Switch Intent-to-Treat Exposed DEXA (LS-ITT-ED) Population which comprised of all participants in the LS-ITT-E Population, and who were registered for the DEXA study. |
| Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score | Baseline (Day 1) and Week 48 | Total hip and lumbar spine BMD was assessed by T-scores and Z-scores. Day 1 was considered as Baseline. Change from Baseline was calculated as the value at Week 48 minus Baseline. DEXA scans of the left 'total hip' (femoral neck, hip, inter-trochanter areas, trochanter) and 'lumbar spine' (lumbar vertebral column) were performed. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values \> -1.0 are considered normal, T-score values \<= -1.0 to \> -2.5 indicate osteopenia, T-score values \<= -2.5 to \<-3.5 indicate osteoporosis and T-score values \<= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores. |
| Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase | Baseline (Day 1), Week 48, Week 100 and Week 148 | T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of same sex. Caucasian reference values were used to calculate T- and Z- scores. T-score values: \> -1.0 is normal; \<= -1.0 to \> -2.5 indicate osteopenia; \<= -2.5 to \<-3.5 indicate osteoporosis; \<= -3.5 indicate severe osteoporosis. Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex in this study. Change from Baseline is post-dose visit value minus Baseline value. Data for Week 48 only represent final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations through Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses. |
| Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase | LS Baseline (Week 48), Week 100, Week 148 | The last pre-switch value (Week 48) was considered as LS Baseline and change from LS Baseline was calculated as the post-dose visit value minus LS Baseline value. DEXA scans of the left 'total hip' (femoral neck, hip, inter-trochanter areas, trochanter) and 'lumbar spine' (lumbar vertebral column) were performed. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values \> -1.0 are considered normal, T-score values \<= -1.0 to \> -2.5 indicate osteopenia, T-score values \<= -2.5 to \<-3.5 indicate osteoporosis and T-score values \<= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores. |
| Percent Change From Baseline in Lumbar Spine BMD at Week 48 | Baseline (Day 1) and Week 48 | Percent change in BMD (expressed as areal density in g/cm\^2) as specified by DEXA scans of the 'lumbar spine' which included the first lumbar vertebra (L1) to the fourth lumbar vertebra (L4) was assessed by areal density at Baseline and Week 48. The difference is adjusted percent change from Baseline to Week 48 between treatment groups. The estimated value in the statistical analysis is this difference and the upper and lower limit values shown are the 95% confidence intervals. Baseline was considered as Day 1 value and percent change from Baseline was calculated as Value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An ANCOVA model was used to compare the difference in percentage change from Baseline at week 48 in lumbar spine BMD between the DTG+RPV and CAR arms. |
| Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Baseline (Day 1) and Week 48 | Total hip and lumbar spine BMD was assessed by Baseline third agent class (INSTI, NNRTI, PI) using T-scores and Z-scores at Baseline and Week 48. DEXA scans of hip and spine were performed. Value at Day 1 was considered as Baseline. Change from Baseline was calculated as the value at Week 48 minus Baseline value. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values \> -1.0 are considered normal, T-score values \<= -1.0 to \> -2.5 indicate osteopenia, T-score values \<= -2.5 to \<-3.5 indicate osteoporosis and T-score values \<= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores. |
| Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Baseline (Day 1), Week 48, Week 100 and Week 148 | Total hip and lumbar spine BMD (expressed as areal density in g/cm\^2) assessed by third agent class (INSTI, NNRTI, PI) at indicated time points. Percent change from Baseline was calculated as post-dose value minus Baseline value divided by Baseline value multiplied by 100. BMD parameters expressed as areal density (g/cm\^2) at Weeks 48, 100 and 148 reflect data adjusted following the ongoing longitudinal and cross-calibration of the multiple DEXA scanner instruments in this study. Data and analyses presented through Week 48 only represent the final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations though Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, the actual values of Week 48 DEXA data may vary slightly between the Week 48 and Week 148 analyses. |
| Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Baseline (Day 1), Week 48, Week 100 and Week 148 | T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of same sex. Caucasian reference values were used to calculate T- and Z-scores. T-score values \> -1.0 is normal; \<= -1.0 to \> -2.5 indicate osteopenia; \<= -2.5 to \<-3.5 indicate osteoporosis; \<= -3.5 indicate severe osteoporosis. Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex in this study. Change from Baseline is the post-dose value minus Baseline value. Data for Week 48 only represents final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations through 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses. |
| Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | LS Baseline (Week 48), Week 100 and Week 148 | Total hip and lumbar spine BMD (expressed as areal density in g/cm\^2) assessed by third agent class (INSTI, NNRTI, PI) at indicated time points. The last pre-switch value (Week 48) was considered as LS Baseline and percent change from LS Baseline was calculated as post-dose value minus LS Baseline value divided by LS Baseline value multiplied by 100. |
| Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | LS Baseline (Week 48), Week 100 and Week 148 | Total hip and lumbar spine BMD was assessed by Baseline third agent (INSTI, NNRTI, PI) using T-scores and Z-scores at indicated time points. DEXA scans of hip and spine were performed. The last pre-switch value (Week 48) was considered as LS Baseline and change from LS Baseline was calculated as the post-dose value minus LS Baseline value. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values \> -1.0 are considered normal, T-score values \<= -1.0 to \> -2.5 indicate osteopenia, T-score values \<= -2.5 to \<-3.5 indicate osteoporosis and T-score values \<= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores. |
| Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent | Baseline (Day 1) and Week 48 | Total hip and lumbar spine BMD (expressed as areal density in g/cm\^2) assessed by third agent class (INSTI, NNRTI, PI) at indicated time points. Percent change from Baseline was calculated as value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. Value at Day 1 was considered as Baseline. An ANCOVA model adjusted for Baseline BMD values was used to compare the difference in percent change from Baseline to Week 48 in total hip BMD or in lumbar spine BMD between the DTG+RPV and CAR arms by third agent class: INSTI, NNRTI or PI. |
Countries
Argentina, Belgium, Canada, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants from early switch dolutegravir (DTG) plus rilpivirine (RPV) treatment groups and from late switch group who continue their current antiretroviral regimen (CAR) through Week 52 across both NCT02429791 and NCT02422797 were included in this sub-study 202094.
Pre-assignment details
Total 146 participants were screened, of which, 44 were screen failures and 102 were registered to study 202094. The study included an early switch phase and a late switch phase.
Participants by arm
| Arm | Count |
|---|---|
| DTG + RPV Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094). | 53 |
| Current Antiretroviral Regimen Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094). | 49 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Early Switch Phase (Up to Week 52) | Withdrawal from parent study | 4 | 5 |
| Late Switch Phase (Week 52 to Week 148) | Prohibited medication use | 5 | 1 |
| Late Switch Phase (Week 52 to Week 148) | Withdrawal from parent study | 2 | 3 |
Baseline characteristics
| Characteristic | Current Antiretroviral Regimen | Total | DTG + RPV |
|---|---|---|---|
| Age, Continuous | 44.8 Years STANDARD_DEVIATION 10.66 | 43.7 Years STANDARD_DEVIATION 10.73 | 42.6 Years STANDARD_DEVIATION 10.8 |
| Race/Ethnicity, Customized American Indian/ Alaska native Heritage | 1 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian- Central/South Asian Heritage | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian- Japanese/East Asian (EA)/ South EA heritage | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black / African American | 7 Participants | 10 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 40 Participants | 84 Participants | 44 Participants |
| Sex: Female, Male Female | 26 Participants | 53 Participants | 27 Participants |
| Sex: Female, Male Male | 23 Participants | 49 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 49 | 0 / 53 | 0 / 44 |
| other Total, other adverse events | 0 / 53 | 0 / 49 | 0 / 53 | 0 / 44 |
| serious Total, serious adverse events | 0 / 53 | 0 / 49 | 0 / 53 | 0 / 44 |
Outcome results
Primary
Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 48
Percent change in BMD (expressed as areal density in grams per centimeter square \[g/cm\^2\]) as specified by dual energy X-ray absorptiometry (DEXA) scans of the left 'total hip' which included the femoral neck, trochanter and inter-trochanter areas was assessed by areal density at Baseline and Week 48. The estimated value in the statistical analysis is this difference and the upper and lower limit values shown are the 95% confidence intervals. Baseline was considered as Day 1 and percent change from Baseline was calculated as Value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An analysis of covariance (ANCOVA) model was used to compare the difference. The analysis was performed on Intent-to-Treat exposed DEXA (ITT-ED) Population which comprised of all participants in the ITT-E Population who received at least one dose of study treatment, and who were registered for the 202094 study.
Time frame: Baseline (Day 1) and Week 48
Population: ITT-ED Population. Only those participants with data available at specified time point were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DTG + RPV | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 48 | 1.34 Percent change |
| Current Antiretroviral Regimen | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 48 | 0.05 Percent change |
p-value: 0.01495% CI: [0.27, 2.31]ANCOVA
Secondary
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase
T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of same sex. Caucasian reference values were used to calculate T- and Z-scores. T-score values \> -1.0 is normal; \<= -1.0 to \> -2.5 indicate osteopenia; \<= -2.5 to \<-3.5 indicate osteoporosis; \<= -3.5 indicate severe osteoporosis. Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex in this study. Change from Baseline is the post-dose value minus Baseline value. Data for Week 48 only represents final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations through 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses.
Time frame: Baseline (Day 1), Week 48, Week 100 and Week 148
Population: ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | INSTI; Total hip; T-score; Week 48; n=7 | 0.119 Scores on a scale | Standard Deviation 0.2171 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | INSTI; Total hip; T-score; Week 100; n=6 | 0.069 Scores on a scale | Standard Deviation 0.2854 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | INSTI; Total hip; T-score; Week 148; n=6 | 0.116 Scores on a scale | Standard Deviation 0.2057 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | INSTI; Total hip; Z-score; Week 48; n=7 | 0.162 Scores on a scale | Standard Deviation 0.2402 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | INSTI; Total hip; Z-score; Week 100; n=6 | 0.161 Scores on a scale | Standard Deviation 0.2912 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | INSTI; Total hip; Z-score; Week 148; n=6 | 0.219 Scores on a scale | Standard Deviation 0.236 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | INSTI; Lumbar spine; T-score; Week 48; n=7 | 0.141 Scores on a scale | Standard Deviation 0.2212 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | INSTI; Lumbar spine; T-score; Week 100; n=6 | 0.087 Scores on a scale | Standard Deviation 0.2611 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | INSTI; Lumbar spine; T-score; Week 148; n=6 | -0.026 Scores on a scale | Standard Deviation 0.0826 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | INSTI; Lumbar spine; Z-score; Week 48; n=7 | 0.196 Scores on a scale | Standard Deviation 0.21 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | INSTI; Lumbar spine; Z-score; Week 100; n=6 | 0.267 Scores on a scale | Standard Deviation 0.3905 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | INSTI; Lumbar spine; Z-score; Week 148; n=6 | 0.191 Scores on a scale | Standard Deviation 0.2644 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | NNRTI; Total hip; T-score; Week 48; n=28 | 0.098 Scores on a scale | Standard Deviation 0.1593 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | NNRTI; Total hip; T-score; Week 100; n=25 | 0.045 Scores on a scale | Standard Deviation 0.1938 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | NNRTI; Total hip; T-score; Week 148; n=24 | 0.028 Scores on a scale | Standard Deviation 0.2786 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | NNRTI; Total hip; Z-score; Week 48; n=28 | 0.107 Scores on a scale | Standard Deviation 0.1574 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | NNRTI; Total hip; Z-score; Week 100; n=25 | 0.077 Scores on a scale | Standard Deviation 0.1856 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | NNRTI; Total hip; Z-score; Week 148; n=24 | 0.071 Scores on a scale | Standard Deviation 0.2958 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | NNRTI; Lumbar spine; T-score; Week 48; n=28 | 0.126 Scores on a scale | Standard Deviation 0.2687 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | NNRTI; Lumbar spine; T-score; Week 100; n=26 | -0.022 Scores on a scale | Standard Deviation 0.3558 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | NNRTI; Lumbar spine; T-score; Week 148; n=25 | -0.015 Scores on a scale | Standard Deviation 0.4802 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | NNRTI; Lumbar spine; Z-score; Week 48; n=28 | 0.150 Scores on a scale | Standard Deviation 0.2669 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | NNRTI; Lumbar spine; Z-score; Week 100; n=26 | 0.021 Scores on a scale | Standard Deviation 0.3539 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | NNRTI; Lumbar spine; Z-score; Week 148; n=25 | 0.049 Scores on a scale | Standard Deviation 0.5248 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | PI; Total hip; T-Score; Week 48; n=11 | 0.097 Scores on a scale | Standard Deviation 0.1731 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | PI; Total hip; T-Score; Week 100; n=10 | 0.118 Scores on a scale | Standard Deviation 0.274 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | PI; Total hip; T-Score; Week 148; n=10 | 0.110 Scores on a scale | Standard Deviation 0.2521 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | PI; Total hip; Z-Score; Week 48; n=11 | 0.106 Scores on a scale | Standard Deviation 0.1823 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | PI; Total hip; Z-Score; Week 100; n=10 | 0.150 Scores on a scale | Standard Deviation 0.2722 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | PI; Total hip; Z-Score; Week 148 ;n=10 | 0.166 Scores on a scale | Standard Deviation 0.2441 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | PI; Lumbar spine; T-Score; Week 48 ;n=11 | 0.172 Scores on a scale | Standard Deviation 0.2406 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | PI; Lumbar spine; T-Score; Week 100 ;n=11 | 0.235 Scores on a scale | Standard Deviation 0.3396 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | PI; Lumbar spine; T-Score; Week 148 ;n=11 | 0.179 Scores on a scale | Standard Deviation 0.3599 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | PI; Lumbar spine; Z-Score; Week 48 ;n=11 | 0.257 Scores on a scale | Standard Deviation 0.2601 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | PI; Lumbar spine; Z-Score; Week 100 ;n=11 | 0.360 Scores on a scale | Standard Deviation 0.3732 |
| DTG + RPV | Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | PI; Lumbar spine; Z-Score; Week 148 ;n=11 | 0.317 Scores on a scale | Standard Deviation 0.2828 |
Secondary
Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase
T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of same sex. Caucasian reference values were used to calculate T- and Z- scores. T-score values: \> -1.0 is normal; \<= -1.0 to \> -2.5 indicate osteopenia; \<= -2.5 to \<-3.5 indicate osteoporosis; \<= -3.5 indicate severe osteoporosis. Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex in this study. Change from Baseline is post-dose visit value minus Baseline value. Data for Week 48 only represent final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations through Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses.
Time frame: Baseline (Day 1), Week 48, Week 100 and Week 148
Population: ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; T-score; Week 48; n=46 | 0.101 Scores on a scale | Standard Deviation 0.1681 |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; T-score; Week 100; n=41 | 0.066 Scores on a scale | Standard Deviation 0.2248 |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; T-score; Week 148; n=40 | 0.062 Scores on a scale | Standard Deviation 0.26 |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; Z-score; Week 48; n=46 | 0.115 Scores on a scale | Standard Deviation 0.1742 |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; Z-score; Week 100; n=41 | 0.107 Scores on a scale | Standard Deviation 0.2222 |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; Z-score; Week 148; n=40 | 0.117 Scores on a scale | Standard Deviation 0.2757 |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; T-score; Week 48; n=46 | 0.139 Scores on a scale | Standard Deviation 0.2511 |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; T-score; Week 100; n=43 | 0.059 Scores on a scale | Standard Deviation 0.351 |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; T-score; Week 148; n=42 | 0.034 Scores on a scale | Standard Deviation 0.4183 |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; Z-score; Week 48; n=46 | 0.182 Scores on a scale | Standard Deviation 0.2563 |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; Z-score; Week 100; n=43 | 0.142 Scores on a scale | Standard Deviation 0.3868 |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; Z-score; Week 148; n=42 | 0.139 Scores on a scale | Standard Deviation 0.4507 |
Secondary
Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score
Total hip and lumbar spine BMD was assessed by T-scores and Z-scores. Day 1 was considered as Baseline. Change from Baseline was calculated as the value at Week 48 minus Baseline. DEXA scans of the left 'total hip' (femoral neck, hip, inter-trochanter areas, trochanter) and 'lumbar spine' (lumbar vertebral column) were performed. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values \> -1.0 are considered normal, T-score values \<= -1.0 to \> -2.5 indicate osteopenia, T-score values \<= -2.5 to \<-3.5 indicate osteoporosis and T-score values \<= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.
Time frame: Baseline (Day 1) and Week 48
Population: ITT-ED Population. Only those participants with data available at specified time point were analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score | Total hip; T-score | 0.09 Scores on a scale |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score | Total hip; Z-score | 0.11 Scores on a scale |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score | Lumbar spine; T-score | 0.13 Scores on a scale |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score | Lumbar spine; Z-score | 0.17 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score | Lumbar spine; Z-score | 0.02 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score | Total hip; T-score | 0.01 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score | Lumbar spine; T-score | 0.01 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score | Total hip; Z-score | 0.02 Scores on a scale |
p-value: 0.01695% CI: [0.02, 0.16]ANCOVA
p-value: 0.02695% CI: [0.01, 0.15]ANCOVA
p-value: 0.04995% CI: [0, 0.23]ANCOVA
p-value: 0.01395% CI: [0.03, 0.27]ANCOVA
Secondary
Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent
Total hip and lumbar spine BMD was assessed by Baseline third agent class (INSTI, NNRTI, PI) using T-scores and Z-scores at Baseline and Week 48. DEXA scans of hip and spine were performed. Value at Day 1 was considered as Baseline. Change from Baseline was calculated as the value at Week 48 minus Baseline value. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values \> -1.0 are considered normal, T-score values \<= -1.0 to \> -2.5 indicate osteopenia, T-score values \<= -2.5 to \<-3.5 indicate osteoporosis and T-score values \<= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.
Time frame: Baseline (Day 1) and Week 48
Population: ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Total hip; T-score; INSTI; n=7, 4 | 0.13 Scores on a scale |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Total hip; T-score; NNRTI; n=28, 24 | 0.09 Scores on a scale |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Total hip; T-score; PI; n=11, 7 | 0.08 Scores on a scale |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Total hip; Z-score; INSTI; n=7, 4 | 0.18 Scores on a scale |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Total hip; Z-score; NNRTI; n=28, 24 | 0.10 Scores on a scale |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Total hip; Z-score; PI; n=11, 7 | 0.08 Scores on a scale |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Lumbar spine; T-score; INSTI; n=7, 3 | 0.14 Scores on a scale |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Lumbar spine; T-score; NNRTI; n=28, 26 | 0.11 Scores on a scale |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Lumbar spine; T-score; PI; n=11, 6 | 0.15 Scores on a scale |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Lumbar spine; Z-score; INSTI; n=7, 3 | 0.19 Scores on a scale |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Lumbar spine; Z-score; NNRTI; n=28, 26 | 0.13 Scores on a scale |
| DTG + RPV | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Lumbar spine; Z-score; PI; n=11,6 | 0.24 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Lumbar spine; Z-score; NNRTI; n=28, 26 | 0.01 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Total hip; T-score; INSTI; n=7, 4 | 0.11 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Lumbar spine; T-score; INSTI; n=7, 3 | -0.22 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Total hip; T-score; NNRTI; n=28, 24 | -0.02 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Lumbar spine; Z-score; INSTI; n=7, 3 | -0.19 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Total hip; T-score; PI; n=11, 7 | 0.01 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Lumbar spine; T-score; NNRTI; n=28, 26 | 0.00 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Total hip; Z-score; INSTI; n=7, 4 | 0.12 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Lumbar spine; Z-score; PI; n=11,6 | 0.19 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Total hip; Z-score; NNRTI; n=28, 24 | 0.00 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Lumbar spine; T-score; PI; n=11, 6 | 0.14 Scores on a scale |
| Current Antiretroviral Regimen | Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent | Total hip; Z-score; PI; n=11, 7 | 0.05 Scores on a scale |
95% CI: [-0.26, 0.3]
95% CI: [0.03, 0.19]
95% CI: [-0.09, 0.24]
95% CI: [-0.25, 0.37]
95% CI: [0.02, 0.18]
95% CI: [-0.14, 0.21]
95% CI: [0.01, 0.71]
95% CI: [-0.03, 0.25]
95% CI: [-0.3, 0.33]
95% CI: [0.03, 0.74]
95% CI: [-0.02, 0.26]
95% CI: [-0.26, 0.34]
Secondary
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase
The last pre-switch value (Week 48) was considered as LS Baseline and change from LS Baseline was calculated as the post-dose visit value minus LS Baseline value. DEXA scans of the left 'total hip' (femoral neck, hip, inter-trochanter areas, trochanter) and 'lumbar spine' (lumbar vertebral column) were performed. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values \> -1.0 are considered normal, T-score values \<= -1.0 to \> -2.5 indicate osteopenia, T-score values \<= -2.5 to \<-3.5 indicate osteoporosis and T-score values \<= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.
Time frame: LS Baseline (Week 48), Week 100, Week 148
Population: LS ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase | Total hip; T-score; Week 100; n=41 | 0.080 Scores on a scale | Standard Deviation 0.1957 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase | Total hip; T-score; Week 148; n=40 | 0.091 Scores on a scale | Standard Deviation 0.1995 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase | Total hip; Z-score; Week 100; n=41 | 0.107 Scores on a scale | Standard Deviation 0.2055 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase | Total hip; Z-score; Week 148; n=40 | 0.125 Scores on a scale | Standard Deviation 0.2117 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase | Lumbar spine; T-score; Week 100; n=41 | 0.111 Scores on a scale | Standard Deviation 0.2914 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase | Lumbar spine; T-score; Week 148; n=40 | 0.049 Scores on a scale | Standard Deviation 0.3204 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase | Lumbar spine; Z-score; Week 100; n=41 | 0.176 Scores on a scale | Standard Deviation 0.2598 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase | Lumbar spine; Z-score; Week 148; n=40 | 0.127 Scores on a scale | Standard Deviation 0.3392 |
Secondary
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase
Total hip and lumbar spine BMD was assessed by Baseline third agent (INSTI, NNRTI, PI) using T-scores and Z-scores at indicated time points. DEXA scans of hip and spine were performed. The last pre-switch value (Week 48) was considered as LS Baseline and change from LS Baseline was calculated as the post-dose value minus LS Baseline value. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values \> -1.0 are considered normal, T-score values \<= -1.0 to \> -2.5 indicate osteopenia, T-score values \<= -2.5 to \<-3.5 indicate osteoporosis and T-score values \<= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.
Time frame: LS Baseline (Week 48), Week 100 and Week 148
Population: LS ITT-ED Population.Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | NNRTI; Hip; T-score; Week 100; n=29 | 0.075 Scores on a scale | Standard Deviation 0.2149 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | INSTI; Hip; T-score; Week 100; n=3 | 0.166 Scores on a scale | Standard Deviation 0.1971 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | INSTI; Hip; T-score; Week 148; n=3 | 0.173 Scores on a scale | Standard Deviation 0.1333 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | INSTI; Hip; Z-score; Week 100; n=3 | 0.167 Scores on a scale | Standard Deviation 0.1623 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | INSTI; Hip; Z-score; Week 148; n=3 | 0.197 Scores on a scale | Standard Deviation 0.08 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | INSTI; Spine; T-score; Week 100; n=3 | 0.201 Scores on a scale | Standard Deviation 0.1102 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | NNRTI; Hip; T-score; Week 148; n=29 | 0.106 Scores on a scale | Standard Deviation 0.2064 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | NNRTI; Hip; Z-score; Week 100; n=29 | 0.101 Scores on a scale | Standard Deviation 0.2261 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | NNRTI; Hip; Z-score; Week 148; n=29 | 0.136 Scores on a scale | Standard Deviation 0.2213 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | NNRTI; Spine; T-score; Week 100; n=29 | 0.103 Scores on a scale | Standard Deviation 0.263 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | NNRTI; Spine; T-score; Week 148; n=29 | 0.045 Scores on a scale | Standard Deviation 0.3441 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | NNRTI; Spine; Z-score; Week 100; n=29 | 0.164 Scores on a scale | Standard Deviation 0.2711 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | NNRTI; Spine; Z-score; Week 148; n=29 | 0.124 Scores on a scale | Standard Deviation 0.3482 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | PI; Hip; T-Score; Week 100; n=9 | 0.069 Scores on a scale | Standard Deviation 0.1309 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | PI; Hip; T-Score; Week 148; n=8 | 0.007 Scores on a scale | Standard Deviation 0.1856 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | PI; Hip; Z-Score; Week 100; n=9 | 0.107 Scores on a scale | Standard Deviation 0.1558 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | PI; Hip; Z-Score; Week 148 ;n=8 | 0.061 Scores on a scale | Standard Deviation 0.2111 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | PI; Spine; T-Score; Week 100 ;n=9 | 0.105 Scores on a scale | Standard Deviation 0.4198 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | PI; Spine; T-Score; Week 148 ;n=8 | 0.044 Scores on a scale | Standard Deviation 0.3052 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | PI; Spine; Z-Score; Week 100 ;n=9 | 0.191 Scores on a scale | Standard Deviation 0.2776 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | PI; Spine; Z-Score; Week 148 ;n=8 | 0.133 Scores on a scale | Standard Deviation 0.3817 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | INSTI; Spine; T-score; Week 148; n=3 | 0.099 Scores on a scale | Standard Deviation 0.1164 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | INSTI; Spine; Z-score; Week 100; n=3 | 0.247 Scores on a scale | Standard Deviation 0.0376 |
| DTG + RPV | Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | INSTI; Spine; Z-score; Week 148; n=3 | 0.145 Scores on a scale | Standard Deviation 0.1888 |
Secondary
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Total hip and lumbar spine BMD (expressed as areal density in g/cm\^2) assessed by third agent class (INSTI, NNRTI, PI) at indicated time points. Percent change from Baseline was calculated as post-dose value minus Baseline value divided by Baseline value multiplied by 100. BMD parameters expressed as areal density (g/cm\^2) at Weeks 48, 100 and 148 reflect data adjusted following the ongoing longitudinal and cross-calibration of the multiple DEXA scanner instruments in this study. Data and analyses presented through Week 48 only represent the final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations though Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, the actual values of Week 48 DEXA data may vary slightly between the Week 48 and Week 148 analyses.
Time frame: Baseline (Day 1), Week 48, Week 100 and Week 148
Population: ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; INSTI; Week 48; n=7 | 1.918 Percent change | Standard Deviation 3.3468 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; INSTI; Week 100; n=6 | 1.165 Percent change | Standard Deviation 4.5857 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; INSTI; Week 148; n=6 | 1.738 Percent change | Standard Deviation 3.1881 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; NNRTI; Week 48; n=28 | 1.422 Percent change | Standard Deviation 2.4137 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; NNRTI; Week 100; n=25 | 0.722 Percent change | Standard Deviation 2.6977 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; NNRTI; Week 148; n=24 | 0.524 Percent change | Standard Deviation 4.0553 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; PI; Week 48; n=11 | 1.401 Percent change | Standard Deviation 2.4406 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; PI; Week 100; n=10 | 1.927 Percent change | Standard Deviation 3.7412 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; PI; Week 148; n=10 | 1.610 Percent change | Standard Deviation 3.5534 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; INSTI; Week 48; n=7 | 1.439 Percent change | Standard Deviation 2.2786 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; INSTI; Week 100; n=6 | 0.779 Percent change | Standard Deviation 2.6627 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; INSTI; Week 148; n=6 | -0.306 Percent change | Standard Deviation 0.8815 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; NNRTI; Week 48; n=28 | 1.570 Percent change | Standard Deviation 2.9752 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; NNRTI; Week 100; n=26 | -0.025 Percent change | Standard Deviation 3.9606 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; NNRTI; Week 148; n=25 | 0.067 Percent change | Standard Deviation 5.4222 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; PI; Week 48; n=11 | 1.977 Percent change | Standard Deviation 2.5587 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; PI; Week 100; n=11 | 2.801 Percent change | Standard Deviation 3.8743 |
| DTG + RPV | Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; PI; Week 148; n=11 | 2.026 Percent change | Standard Deviation 3.8869 |
Secondary
Percent Change From Baseline in Lumbar Spine BMD at Week 48
Percent change in BMD (expressed as areal density in g/cm\^2) as specified by DEXA scans of the 'lumbar spine' which included the first lumbar vertebra (L1) to the fourth lumbar vertebra (L4) was assessed by areal density at Baseline and Week 48. The difference is adjusted percent change from Baseline to Week 48 between treatment groups. The estimated value in the statistical analysis is this difference and the upper and lower limit values shown are the 95% confidence intervals. Baseline was considered as Day 1 value and percent change from Baseline was calculated as Value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An ANCOVA model was used to compare the difference in percentage change from Baseline at week 48 in lumbar spine BMD between the DTG+RPV and CAR arms.
Time frame: Baseline (Day 1) and Week 48
Population: ITT-ED Population. Only those participants with data available at specified time point were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DTG + RPV | Percent Change From Baseline in Lumbar Spine BMD at Week 48 | 1.46 Percent change |
| Current Antiretroviral Regimen | Percent Change From Baseline in Lumbar Spine BMD at Week 48 | 0.15 Percent change |
p-value: 0.03995% CI: [0.07, 2.57]ANCOVA
Secondary
Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent
Total hip and lumbar spine BMD (expressed as areal density in g/cm\^2) assessed by third agent class (INSTI, NNRTI, PI) at indicated time points. Percent change from Baseline was calculated as value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. Value at Day 1 was considered as Baseline. An ANCOVA model adjusted for Baseline BMD values was used to compare the difference in percent change from Baseline to Week 48 in total hip BMD or in lumbar spine BMD between the DTG+RPV and CAR arms by third agent class: INSTI, NNRTI or PI.
Time frame: Baseline (Day 1) and Week 48
Population: ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DTG + RPV | Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent | Total hip; NNRTI; n=28, 24 | 1.33 Percent change |
| DTG + RPV | Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent | Lumbar spine; INSTI; n=7, 3 | 1.43 Percent change |
| DTG + RPV | Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent | Total hip; INSTI; n=7, 4 | 2.03 Percent change |
| DTG + RPV | Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent | Lumbar spine; NNRTI; n=28, 26 | 1.38 Percent change |
| DTG + RPV | Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent | Total hip; PI; n=11, 7 | 1.11 Percent change |
| DTG + RPV | Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent | Lumbar spine; PI; n=11, 6 | 1.78 Percent change |
| Current Antiretroviral Regimen | Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent | Lumbar spine; PI; n=11, 6 | 1.40 Percent change |
| Current Antiretroviral Regimen | Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent | Total hip; INSTI; n=7, 4 | 1.38 Percent change |
| Current Antiretroviral Regimen | Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent | Total hip; NNRTI; n=28, 24 | -0.27 Percent change |
| Current Antiretroviral Regimen | Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent | Total hip; PI; n=11, 7 | 0.12 Percent change |
| Current Antiretroviral Regimen | Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent | Lumbar spine; INSTI; n=7, 3 | -2.42 Percent change |
| Current Antiretroviral Regimen | Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent | Lumbar spine; NNRTI; n=28, 26 | 0.12 Percent change |
95% CI: [-3.51, 4.81]
95% CI: [0.39, 2.81]
95% CI: [-1.39, 3.38]
95% CI: [0.67, 7.03]
95% CI: [-0.26, 2.76]
95% CI: [-3, 3.77]
Secondary
Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase
Percent change in BMD (expressed as areal density in g/cm\^2) as specified by DEXA scans of left 'total hip' which included femoral neck, trochanter and inter-trochanter areas and 'lumbar spine' which included L1 to L4 was assessed by areal density. Percent change from Baseline is post-dose value minus Baseline value divided by Baseline value multiplied by 100. BMD parameters at Weeks 48, 100 and 148 reflect data adjusted following the ongoing longitudinal and cross-calibration of multiple DEXA scanner instruments in this study. Data presented through Week 48 only represent results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations though Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses.
Time frame: Baseline (Day 1), Week 48, Week 100 and Week 148
Population: ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DTG + RPV | Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; Week 48; n=46 | 1.492 Percent change |
| DTG + RPV | Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; Week 100; n=41 | 1.081 Percent change |
| DTG + RPV | Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Total hip; Week 148; n=40 | 0.978 Percent change |
| DTG + RPV | Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; Week 48; n=46 | 1.648 Percent change |
| DTG + RPV | Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; Week 100; n=43 | 0.810 Percent change |
| DTG + RPV | Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase | Lumbar spine; Week 148; n=42 | 0.526 Percent change |
Secondary
Percent Change From Late Switch (LS) Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD-CAR Late Switch Group Through Late Switch Phase
Percent change in BMD (expressed as areal density in g/cm\^2) as specified by DEXA scans of the left 'total hip' which included the femoral neck, trochanter and inter-trochanter areas was assessed by areal density at indicated time points. Percent change in BMD as specified by DEXA scans of the 'lumbar spine' which included the first lumbar vertebra (L1) to the fourth lumbar vertebra (L4) was assessed by areal density at indicated time points. The last pre-switch value (Week 48) was considered as LS Baseline and percent change from LS Baseline was calculated as post-dose visit value minus LS Baseline value divided by LS Baseline value multiplied by 100. The analysis was based on Late-Switch Intent-to-Treat Exposed DEXA (LS-ITT-ED) Population which comprised of all participants in the LS-ITT-E Population, and who were registered for the DEXA study.
Time frame: LS Baseline (Week 48), Week 100 and Week 148
Population: LS ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DTG + RPV | Percent Change From Late Switch (LS) Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD-CAR Late Switch Group Through Late Switch Phase | Total hip; Week 100; n=41 | 1.107 Percent change |
| DTG + RPV | Percent Change From Late Switch (LS) Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD-CAR Late Switch Group Through Late Switch Phase | Total hip; Week 148; n=40 | 1.275 Percent change |
| DTG + RPV | Percent Change From Late Switch (LS) Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD-CAR Late Switch Group Through Late Switch Phase | Lumbar spine; Week 100; n=41 | 1.135 Percent change |
| DTG + RPV | Percent Change From Late Switch (LS) Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD-CAR Late Switch Group Through Late Switch Phase | Lumbar spine; Week 148; n=40 | 0.436 Percent change |
Secondary
Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase
Total hip and lumbar spine BMD (expressed as areal density in g/cm\^2) assessed by third agent class (INSTI, NNRTI, PI) at indicated time points. The last pre-switch value (Week 48) was considered as LS Baseline and percent change from LS Baseline was calculated as post-dose value minus LS Baseline value divided by LS Baseline value multiplied by 100.
Time frame: LS Baseline (Week 48), Week 100 and Week 148
Population: LS ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTG + RPV | Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | Total hip; INSTI; Week 100; n=3 | 2.298 Percent change | Standard Deviation 2.751 |
| DTG + RPV | Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | Total hip; INSTI; Week 148; n=3 | 2.405 Percent change | Standard Deviation 1.8787 |
| DTG + RPV | Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | Total hip; NNRTI; Week 100; n=29 | 1.049 Percent change | Standard Deviation 2.9845 |
| DTG + RPV | Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | Total hip; NNRTI; Week 148; n=29 | 1.498 Percent change | Standard Deviation 2.8487 |
| DTG + RPV | Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | Total hip; PI; Week 100; n=9 | 0.898 Percent change | Standard Deviation 1.7838 |
| DTG + RPV | Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | Total hip; PI; Week 148; n=8 | 0.042 Percent change | Standard Deviation 2.564 |
| DTG + RPV | Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | Lumbar Spine; INSTI; Week 100; n=3 | 2.195 Percent change | Standard Deviation 1.1188 |
| DTG + RPV | Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | Lumbar Spine; INSTI; Week 148; n=3 | 1.121 Percent change | Standard Deviation 1.3711 |
| DTG + RPV | Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | Lumbar Spine; NNRTI; Week 100; n=29 | 1.017 Percent change | Standard Deviation 2.7142 |
| DTG + RPV | Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | Lumbar Spine; NNRTI; Week 148; n=29 | 0.335 Percent change | Standard Deviation 3.5996 |
| DTG + RPV | Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | Lumbar Spine; PI; Week 100; n=9 | 1.160 Percent change | Standard Deviation 5.105 |
| DTG + RPV | Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase | Lumbar Spine; PI; Week 148; n=8 | 0.546 Percent change | Standard Deviation 3.1654 |