None listed
Conditions
Brief summary
The purpose of this study is to find out whether treatment with zoledronic acid or switching from tenofovir to another anti-HIV drug is more effective for improving low bone density over 24 months. These two options can improve low BMD in patients receiving tenofovir, but it is not yet known which one is the best as both strategies have their own advantages and disadvantages. Current evidence suggests that zoledronic acid may be better in terms of increasing bone density but it is not known for sure, hence the purpose of this study.
Interventions
Participants currently taking tenofovir as part of their stable HIV therapy, have no detectable HIV in the blood, have thin bones, and who could safely use either zoledronic acid or switch their tenofovir to another anti-HIV drug will be randmolmly assigned to either:
1. zoledronic acid 5 mg intravenous (IV) yearly (2 doses) OR
2. switch from tenofovir to another potent anti-HIV drug (without commencing zoledronic acid) selected by the study doctor at the first study visit.
Switch ARV: Dose am
Participants currently taking tenofovir as part of their stable HIV therapy, have no detectable HIV in the blood, have thin bones, and who could safely use either zoledronic acid or switch their tenofovir to another anti-HIV drug will be randmolmly assigned to either: 1. zoledronic acid 5 mg intravenous (IV) yearly (2 doses) OR 2. switch from tenofovir to another potent anti-HIV drug (without commencing zoledronic acid) selected by the study doctor at the first study visit. Switch ARV: Dose amounts and frequency will depend on switch ARV selected by the study doctor, however at least daily. Mode of administration is oral for duration of the study (2 years).
Sponsors
St Vincents Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. provision of written, informed consent 2. HIV infected adult equal to or greater than 18 years of age 3. stable and well-tolerated ART including tenofovir for the preceding 6 months 4. plasma HIV RNA <50 copies/ml for at least the preceding 3 months 5. eGFR >60ml/min (patients at higher risk of zoledronic acid/tenofovir nephrotoxicity) 6. spine or neck of femur T score = -1.0 measured by DXA (i.e. osteopenia)
Exclusion criteria
1. prior bisphosphonate therapy 2. use of tenofovir for previously active chronic hepatitis B co-infection 3. requiring therapy for low BMD (e.g. prior fragility fracture; other metabolic bone disease) 4. other secondary causes of osteoporosis: hypogonadism (low total testosterone/oestrogen and luteinizing hormone >25% above upper normal limit); hypothyroidism (low T4 and elevated TSH); hyperparathyroidism (elevated parathyroid hormone); inhaled fluticasone in a patient receiving ritonavir; prednisolone equal to or greater than 7.5mg/d or equivalent 5. contra-indications to zoledronic acid (known hypersensitivity to bisphosphonates, hypocalcaemia, prior or current uveitis, eGFR<35 mL/min) 6. recent (within the last 2 months) or planned dental surgery (at investigators discretion) 7. previous virological failure, genotypic resistance, intolerance or contraindication to proposed switch antiretroviral drug 8. HLA-B*5701 positive (abacavir contra-indicated) or prior ischaemic cardiovascular disease if planning to switch from tenofovir to abacavir 9. concurrent use of any nephrotoxic drug 10. breast-feeding or pregnancy
Outcome results
None listed