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Bone Mineral Density in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Adult Subjects Switching From a Tenofovir Regimen to a Dolutegravir Plus Rilpivirine Regimen

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Subjects do not receive study medication in this study 202094

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CAR

DTG 50 mg + RPV 25 mg

Arm Description

Participants do not receive study medication in this study 202094. Participants group carried over from the parent study 201636 (SWORD-1) or 201637 (SWORD-2).

Participants do not receive study medication in this study 202094. Participants group carried over from the parent study 201636 (SWORD-1) or 201637 (SWORD-2)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02478632

First Posted

May 28, 2015

Last Updated

September 24, 2020

Sponsor

ViiV Healthcare

Collaborators

Janssen Pharmaceuticals, GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02478632

Brief Title

Bone Mineral Density in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Adult Subjects Switching From a Tenofovir Regimen to a Dolutegravir Plus Rilpivirine Regimen

Official Title

An Evaluation of Bone Mineral Density in HIV-1-infected Adult Subjects Switching From a Tenofovir-containing Antiretroviral Therapy Regimen to a Dolutegravir Plus Rilpivirine Regimen

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

June 12, 2015 (Actual)

Primary Completion Date

September 16, 2016 (Actual)

Study Completion Date

August 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ViiV Healthcare

Collaborators

Janssen Pharmaceuticals, GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CAR

Arm Type

Active Comparator

Arm Description

Participants do not receive study medication in this study 202094. Participants group carried over from the parent study 201636 (SWORD-1) or 201637 (SWORD-2).

Arm Title

DTG 50 mg + RPV 25 mg

Arm Type

Experimental

Arm Description

Participants do not receive study medication in this study 202094. Participants group carried over from the parent study 201636 (SWORD-1) or 201637 (SWORD-2)

Intervention Type

Drug

Intervention Name(s)

Subjects do not receive study medication in this study 202094

Intervention Description

Participants do not receive study medication in this study 202094.

Primary Outcome Measure Information:

Title

Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 48

Description

Time Frame

Baseline (Day 1) and Week 48

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Lumbar Spine BMD at Week 48

Description

Time Frame

Baseline (Day 1) and Week 48

Title

Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase

Description

Time Frame

Baseline (Day 1), Week 48, Week 100 and Week 148

Title

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

Description

Time Frame

LS Baseline (Week 48), Week 100 and Week 148

Title

Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score

Description

Time Frame

Baseline (Day 1) and Week 48

Title

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

Description

Time Frame

Baseline (Day 1), Week 48, Week 100 and Week 148

Title

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

Description

Time Frame

LS Baseline (Week 48), Week 100, Week 148

Title

Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent

Description

Time Frame

Baseline (Day 1) and Week 48

Title

Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent

Description

Time Frame

Baseline (Day 1) and Week 48

Title

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

Description

Time Frame

Baseline (Day 1), Week 48, Week 100 and Week 148

Title

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

Description

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

Title

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

Description

Time Frame

LS Baseline (Week 48), Week 100 and Week 148

Title

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

Description

Time Frame

LS Baseline (Week 48), Week 100 and Week 148

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

ViiV Healthcare

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

GSK Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

Facility Name

GSK Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

GSK Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

GSK Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63108

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

GSK Investigational Site

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

Country

United States

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1425AWK

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1202ABB

Country

Argentina

Facility Name

GSK Investigational Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

1141

Country

Argentina

Facility Name

GSK Investigational Site

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

GSK Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

GSK Investigational Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 2T1

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2N2

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1T1

Country

Canada

Facility Name

GSK Investigational Site

City

Québec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

GSK Investigational Site

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

GSK Investigational Site

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

GSK Investigational Site

City

Cartagena (Murcia)

ZIP/Postal Code

30202

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Murcia

ZIP/Postal Code

30003

Country

Spain

Facility Name

GSK Investigational Site

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

GSK Investigational Site

City

Palma de Mallorca

ZIP/Postal Code

07198

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing URL

https://clinicalstudydatarequest.com/Posting.aspx?ID=20273

Citations:

PubMed Identifier

29239893

Citation

McComsey GA, Lupo S, Parks D, Poggio MC, De Wet J, Kahl LP, Angelis K, Wynne B, Vandermeulen K, Gartland M, Cupo M, Aboud M; 202094 Sub-Study Investigators. Switch from tenofovir disoproxil fumarate combination to dolutegravir with rilpivirine improves parameters of bone health. AIDS. 2018 Feb 20;32(4):477-485. doi: 10.1097/QAD.0000000000001725.

Results Reference

background

Learn more about this trial

Bone Mineral Density in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Adult Subjects Switching From a Tenofovir Regimen to a Dolutegravir Plus Rilpivirine Regimen

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Bone Mineral Density in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Adult Subjects Switching From a Tenofovir Regimen to a Dolutegravir Plus Rilpivirine Regimen

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial