Viewing Study NCT02815566



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Last Modification Date: 2024-10-26 @ 12:04 PM
Study NCT ID: NCT02815566
Status: COMPLETED
Last Update Posted: 2023-01-19
First Post: 2016-06-22

Brief Title: Bone Health in Aging HIV Infected Women
Sponsor: University Health Network Toronto
Organization: University Health Network Toronto

Study Overview

Official Title: Bone Health in Aging HIV Infected Women Improvement or Prevention of Changes in Bone Mineral Density by Switching Antiretroviral Agents Is There an Optimal Time to Intervene
Status: COMPLETED
Status Verified Date: 2022-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BEING
Brief Summary: Design Open-label randomised multicenter international strategic trial of older women on combination antiretroviral therapy cART containing tenofovir-emtricitabine TDFFTC with HIV RNA suppression for 6 months to 1 Immediate switch of TDFFTC to tenofovir alafenamide-emtricitabine TAFFTC while continuing the third antiretroviral agent 2 Delayed switch with switch of TDFFTC to TAFFTC at 48 weeks while continuing the third agent Follow up of all subjects to 96 weeks

Subject Population The anticipated sample size is 128 HIV infected women aged 45-55 years peri or early post menopause

Primary endpoint Percentage change from baseline bone mineral density BMD at the lumbar spine at weeks 48 and 96

Secondary Endpoints BMD change at hip trabecular bone score estimated bone strength by high resolution peripheral quantitative computerized tomography HR-pQCT muscle quality geriatric assessment biomarkers of bone immune activation and inflammation HIV viral suppression safety lipid and renal function cardiovascular risk scores at weeks 48 and 96

Expected Outcomes To determine if a switch from TDFFTC to TAFFTC improves BMD to a degree correlating with a decreased risk of fragility fracture in aging HIV infected women Secondary outcomes will assess bone strength using new imaging modalities timing of switch and renal health This data will be used by health policy makers and providers to determine the proper use of TAFFTC in the aging HIV population
Detailed Description: A Randomized controlled clinical trial RCT of immediate vs delayed switch from TDFFTC to TAFFTC to define the impact of switching ARV on BMD in different stages of the aging trajectory in HIV infected women Included is a geriatric assessment based on the conceptualization of health transition across menopause

Study Hypothesis The primary hypothesis is that switching from TDFFTC will improve BMD to a degree that correlates with a lower fracture risk in aging HIV women We will further explore our theory that the impact is greater in those in the early stages of menopause and in those who also receive a protease inhibitor PI as the third antiretroviral agent ARV

Primary objectives To determine if 1 Switching HIV women on TDFFTC to TAFFTC increases BMD at the spine at 48 weeks relative to those who continue TDFFTC 2 To determine if any observed improvements continue or stabilize in the year after switch

Hypothesis generating objectives To determine if the effect of switching from TDFFTC to TAFFTC on BMD varies by stage of menopause and by third ARV

Study design This study is double blind placebo controlled randomised 11 multicentre strategic trial Patients will be randomised to immediate vs delayed switch with randomization allocation arranged to minimize differences between treatment group with respect to stage of menopause peri- menopause vs early post menopause and site Study population HIV positive women who are in the peri-menopausal period or those within 10 years post menopause to capture those with greatest risk of BMD loss As menopause typically occurs earlier in HIV women we include those aged 45-55 years They must be on a cART regimen containing TDFFTC with HIV RNA 50 cml for at least 6 months

Intervention

1 Immediate switch of TDFFTC to TAFFTC while maintaining the third ARV agent
2 Delayed switch of TDFFTC to TAFFTC at 48 weeks while maintaining the third ARV agent

Randomization A computer-generated randomization list will be prepared prior to study onset by a statistician unassociated with the study Randomization will be stratified by study centre

Primary endpoint Comparison of the immediate vs delayed group in the change from baseline in BMD at the lumbar spine at week 48 and 96

Secondary endpoints Will compare changes between the immediate and delayed group from data collected at screening or baseline and weeks 48 and 96

change from baseline in BMD at hip Changes in Bone architecture as determined by Trabecular bone scan TBS and HRpQCT high resolution peripheral quantitative computerized tomography Toronto site Changes in 10 year fracture risk determined by country specific FRAX fracture risk assessment calculator
with HIV-1 RNA 50 cml Change from baseline in geriatric functional measures frailty performance and balance Change from baseline in muscle quality Sarcopenia - grip strength measured by a Dynamometer Change from baseline in lipid values and Framingham cardiovascular risk scores Changes in renal tubular and glomerular function GFR glomerular filtration rate Creatinine urine albumin creatinine and proteincreatinine glucosuria Safety clinical and laboratory adverse events Changes in biomarkers of inflammation coagulation and bone metabolism Tolerability EuroQoL questionnaire

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
IN-CA-311-3963 OTHER_GRANT Gilead None