Status:
COMPLETED
Switch From Tenofovir to Raltegravir for Low Bone Mineral Density
Lead Sponsor:
St Vincent's Hospital, Sydney
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Holdsworth House Medical Practice
Conditions:
HIV
Osteopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if low bone mineral density (a measurement of how thick and strong bones are) improves in adults with HIV infection who switch their HIV medication tenofovir ...
Eligibility Criteria
Inclusion
- provision of written, informed consent
- HIV-infected adults at least 18 years of age
- receiving stable ART including TDF and a r/PI for the previous 6 months
- no prior PI genotypic resistance or known replication of HIV in patients receiving a PI
- plasma HIV RNA \< 50 copies/ml for at least the previous 3 months
- spine or neck of femur t-score ≤ -1.0 (i.e. WHO-defined osteopenia) measured by dual energy x-ray absorptiometry (DEXA)
Exclusion
- participation in any other clinical trial (unless approved by the study PI)
- use of TDF for previously active chronic hepatitis B infection
- receiving or requiring therapy for low BMD (including prior fragility fracture)
- using oral corticosteroids or inhaled fluticasone
- virological failure on, or intolerance to, RAL
- contra-indication to RAL therapy (see appendix 2)
- breast-feeding
- pregnancy
- secondary, endocrinological cause of low BMD:25-hydroxy vitamin D deficiency, hypogonadism: a)symptomatic b)asymptomatic defined by total testosterone \> 25% below lower limit of reference range and/or luteinizing hormone \> 2 x upper limit of normal (ULN),untreated hypothyroidism or hyperparathyroidism according to local reference ranges
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00939874
Start Date
October 1 2009
End Date
April 1 2014
Last Update
June 12 2015
Active Locations (4)
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1
East Sydney Doctors
Sydney, New South Wales, Australia, 2010
2
Holdsworth Medical Practice
Sydney, New South Wales, Australia, 2010
3
St Vincents Hospital
Sydney, New South Wales, Australia, 2010
4
The Alfred Hospital
Melbourne, Victoria, Australia, 3004