Status:
UNKNOWN
Regional Bone Turnover Using 18F-fluoride-PET/CT in HIV-1-infected Men: PETRAM Study
Lead Sponsor:
University College, London
Collaborating Sponsors:
King's College London
Conditions:
HIV Infections
Eligibility:
MALE
40-65 years
Brief Summary
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 reg...
Detailed Description
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 def...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 24 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03405012
Start Date
July 24 2018
End Date
January 1 2020
Last Update
July 30 2018
Active Locations (1)
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1
Mortimer Market Centre
London, United Kingdom, WC1E 6JB