Regional Bone Turnover Using 18F-fluoride-PET/CT in HIV-1-infected Men: PETRAM Study (PETRAM)
Understanding Changes in Treatment-related Regional Bone Turnover Using 18F-fluoride-PET/CT in HIV-1-infected Men: PETRAM Study
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Study Design:
This is an observational, open-label, non-randomised, single centre, 48-week study to explore the utility of a novel scanning platform exploring bone turnover during an immediate or deferred (for 48 weeks) switch from Eviplera® to Odefsey® in HIV-1 infected men aged 40 years or older, and stable on Eviplera®.
Participants:
HIV-1-infected males, aged ≥40 years, on Eviplera® >24 weeks, with plasma HIV RNA (pVL) <50cp/mL and without any known history of osteoporosis.
Groups to be Compared: 1. HIV-1-infected males aged ≥40, stable on Eviplera® (rilpivirine (RPV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)) and remaining on EvipleraÒ for 48 weeks on study; 2. HIV-1-infected males aged ≥40 years, switched to Odefsey® (RPV/FTC/tenofovir alafenamide (TAF)) at study enrollment.
Study Hypothesis: We hypothesis that there will be ongoing subclinical loss of bone at the hip and lumbar spine as measured by 18F-fluoride-PET/CT in those remaining of Eviplera®, and in those switching to Odefsey® there will be reversal of some of this subclinical loss at 24 and 48 weeks post switch.
Primary Outcome Measure(s):To determine the change in regional bone formation at the hip and lumbar spine as measured by 18F-fluoride-PET/CT at 24 weeks post switch from Eviplera® to Odefsey®.
Secondary Outcome Measure(s): 1. Change in regional bone formation at the hip and lumbar spine as measured by 18F-fluoride-PET/CT at 48 weeks post switch from Eviplera® to Odefsey®; 2. Assess safety and tolerability of switching to Odefsey®; 3. To compare DXA changes at the hip and lumbar spine to those detected on 18F-fluoride-PET/CT; 4. Measure changes in plasma/serum bone biomarkers over 24 and 48 weeks; 5. To measure the changes in FRAX® score at week 48.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
-
-
-
London, Vereinigtes Königreich, WC1E 6JB
- Rekrutierung
- Mortimer Market Centre
-
Kontakt:
- Sarah Pett, MD
- E-Mail: s.pett@ucl.ac.uk
-
Kontakt:
- Andrea Cartier
- E-Mail: a.cartier@ucl.ac.uk
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in regional bone formation at the hip and lumbar spine as measured by 18F-PET/CT at 24 weeks.
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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
Zeitfenster: 48 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). measured by 18F-PET/CT at 48 weeks |
48 weeks
|
|
Bone mineral density at the hip and lumbar spine measured by DXA vs. 18F-PET/CT;
Zeitfenster: 24 and 48 weeks
|
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
|
|
The changes in bone biomarkers over 24 and 48 weeks with changes in 18F-PET/CT;
Zeitfenster: 24 and 48 weeks
|
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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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. doi: 10.1359/jbmr.2003.18.12.2215.
- 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-naive HIV-1-infected patients. HIV Clin Trials. 2007 May-Jun;8(3):164-72. doi: 10.1310/hct0803-164.
- 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. doi: 10.1359/jbmr.2000.15.4.763.
- 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 Densitom. 2007 Jan-Mar;10(1):46-54. doi: 10.1016/j.jocd.2006.10.006. Epub 2006 Dec 27.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- HIV-Infektionen
Andere Studien-ID-Nummern
- 16/0657
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur HIV-Infektionen
-
Jianfeng XieRekrutierungCLABSI – Central Line Associated Bloodstream InfectionChina
-
Assiut UniversityNoch keine RekrutierungCLABSI – Central Line Associated Bloodstream Infection | Peripher eingeführter Zentralkatheter | Nabelschnur venöser Katheter
-
Duke UniversityAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Vereinigte Staaten
-
Catholic University of the Sacred HeartAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
Abbott Medical DevicesThoratec CorporationAbgeschlossenDriveline Heart-assisted Device Related InfectionVereinigte Staaten
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekrutierungCentral Line-associated Bloodstream Infection (CLABSI)Niederlande
-
National Taiwan University Hospital Hsin-Chu BranchAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
University of MalayaTeleflexAbgeschlossenCLABSI – Central Line Associated Bloodstream InfectionMalaysia
-
University of ZurichNoch keine RekrutierungCentral Line-associated Bloodstream Infection (CLABSI) | Katheterbedingte Blutstrominfektion
-
China National Center for Cardiovascular DiseasesChinese Academy of Medical Sciences, Fuwai HospitalAktiv, nicht rekrutierendLungenentzündung | Sepsis | Infektion | Driveline Heart-assisted Device Related InfectionChina