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
Information source: ViiV Healthcare
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection, Human Immunodeficiency Virus
Intervention: Subjects do not receive study medication in this study 202094 (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: ViiV Healthcare Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: ViiV Healthcare
Overall contact: US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
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.
Clinical Details
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 design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage change from baseline at Week 48 in total hip BMD as assessed by areal density in gram per centimeter square (g/cm^2)
Secondary outcome: Percentage change from baseline at Week 48 in lumbar spine BMD as assessed by areal density in g/cm^2Percentage change from baseline through Week 148 in the DTG+RPV arm in lumbar spine and total hip BMD as assessed by areal density in g/cm^2 Percentage change from Week 48 through Week 148 (96 Weeks post switch) in the CAR arm in lumbar spine and total hip BMD as assessed by areal density in g/cm^2 Change from baseline to Week 48 in lumbar spine and total hip BMD as assessed by T-scores and Z-scores Change from baseline through Week 148 in the DTG+RPV arm in lumbar spine and total hip BMD as assessed by T-scores and Z-scores Change from Week 48 through Week 148 (96 Weeks post switch) in the CAR arm in lumbar spine and total hip BMD as assessed by T-scores and Z-scores Percent change from baseline at Week 48 in lumbar spine and total hip BMD as assessed by areal density in g/cm^2 , and change from baseline in T-scores and Z-scores in both DTG + RPV and CAR arms by baseline third agent Percent change from baseline through Week 148 in the DTG + RPV arm in lumbar spine and total hip BMD as assessed by areal density in g/cm^2, and change from baseline in T-scores and Z-scores by baseline third agent Percent change from Week 48 through Week 148 (96 Weeks post switch) in the CAR arm in lumbar spine and total hip BMD as assessed by areal density in g/cm^2, and change from baseline in T-scores and Z-scores by baseline third agent.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Barcelona 08035, Spain; Recruiting US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Barcelona 08907, Spain; Not yet recruiting US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Madrid 28046, Spain; Recruiting US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
Additional Information
Starting date: June 2015
Last updated: June 17, 2015
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