HIV Infections Clinical Trial
— PETRAMOfficial title:
Understanding Changes in Treatment-related Regional Bone Turnover Using 18F-fluoride-PET/CT in HIV-1-infected Men: PETRAM Study
NCT number | NCT03405012 |
Other study ID # | 16/0657 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 24, 2018 |
Est. completion date | January 1, 2020 |
This is a 48 week study to explore the pathogenesis of HIV treatment related bone disease by using a novel imaging technique, 18F-Fluoride Positron Emission Tomography (18F-PET/CT), which measures regional bone formation. The study will include other standard methods (serum bone markers and DXA) for comparison. Patients enrolled will have baseline, week 24 and week 48 assessment, with baseline being the date of replacing tenofovir disoproxil fumarate (TDF) in their HIV treatment regimen with tenofavir alafenamide fumarate (TAF), compared to a control group continuing TDF. Allocation to change to TAF or continue TDF will be randomised to allow an unbiased assessment of bone changes.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | January 1, 2020 |
Est. primary completion date | November 1, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 65 Years |
Eligibility |
INCLUSION CRITERIA - HIV-1-infected men aged =40 years; - Virologically suppressed (<50 cp/mL) on Eviplera® for >24 weeks; - No known history of osteoporosis (defined as a T-score > -2.5 at the lumbar spine, femoral neck or total hip using DXA); - Willing to switch immediately to OdefseyÒ or remain on EvipleraÒ for the duration of the study; - No immediate toxicity reason in the opinion of the investigator to switch away from Eviplera; - Willing to comply with study procedures. EXCLUSION CRITERIA - Contraindication to the receipt of TAF; - Contraindication to 18F-fluoride-PET/CT scanning; - Anticipated to require additional radiological imaging during the 48 weeks of study participation with a total cumulative radiation dose of >50 millisieverts (mSv); - Current or previous treatment (within the prior 12 months) which can affect bone metabolism including systemic corticosteroids for >4 weeks and bisphosphonates; - Hepatitis C coinfected. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Mortimer Market Centre | London |
Lead Sponsor | Collaborator |
---|---|
University College, London | King's College London |
United Kingdom,
Cassetti I, Madruga JV, Suleiman JM, Etzel A, Zhong L, Cheng AK, Enejosa J; Study 903E Team*. The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naïve HIV-1-infected patients. HIV Clin Tr — View Citation
Cook GJ, Lodge MA, Blake GM, Marsden PK, Fogelman I. Differences in skeletal kinetics between vertebral and humeral bone measured by 18F-fluoride positron emission tomography in postmenopausal women. J Bone Miner Res. 2000 Apr;15(4):763-9. — View Citation
Frost ML, Cook GJ, Blake GM, Marsden PK, Benatar NA, Fogelman I. A prospective study of risedronate on regional bone metabolism and blood flow at the lumbar spine measured by 18F-fluoride positron emission tomography. J Bone Miner Res. 2003 Dec;18(12):2215-22. — View Citation
Frost ML, Cook GJ, Blake GM, Marsden PK, Fogelman I. The relationship between regional bone turnover measured using 18F-fluoride positron emission tomography and changes in BMD is equivalent to that seen for biochemical markers of bone turnover. J Clin De — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in regional bone formation at the hip and lumbar spine as measured by 18F-PET/CT at 24 weeks. | Regions of interest will be applied to various regions within the hip including but are not limited to the femoral neck, intertrochanteric region, trochanter and total proximal femur. Further regions of interest will be applied to each vertebral body, skull, pelvis and femoral shaft using the static scan for the calculation of standardised uptake values (SUV). At week 24 | 24 weeks | |
Secondary | The change in regional bone formation at the hip and lumbar spine as measured by 18F-PET/CT at 48 weeks in patients starting a TAF-based ART regimen | Regions of interest will be applied to various regions within the hip including but are not limited to the femoral neck, intertrochanteric region, trochanter and total proximal femur. Further regions of interest will be applied to each vertebral body, skull, pelvis and femoral shaft using the static scan for the calculation of standardised uptake values (SUV). measured by 18F-PET/CT at 48 weeks |
48 weeks | |
Secondary | Bone mineral density at the hip and lumbar spine measured by DXA vs. 18F-PET/CT; | Regions of interest will be applied to including but not limited to the femoral neck, intertrochanteric region, total hip, each lumbar vertebral body, and upper femoral shaft for the calculation of Ki which reflects regional bone perfusion and bone turnover and will be compared to results obtained Dual-energy x-ray absorptiometry (DXA) scans will be performed at baseline (Visit 1b), weeks 24 (Visit 2b) and 48 (Visit 3b) to evaluate the change in areal bone mineral density (BMD) (in g/cm2) in response to treatment at the lumbar spine (L1-L4), total hip, femoral neck and whole body using standard protocols. | 24 and 48 weeks | |
Secondary | The changes in bone biomarkers over 24 and 48 weeks with changes in 18F-PET/CT; | Regions of interest will be applied to including but not limited to the femoral neck, intertrochanteric region, total hip, each lumbar vertebral body, and upper femoral shaft for the calculation of Ki which reflects regional bone perfusion and bone turnover, with changes in bone biomarkers. The bone markers to be analysed include, but are not limited to, procollagen Type I N terminal propeptide (PINP), and cross-linked C telopeptides of Type I collagen (CTX). | 24 and 48 weeks |
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