Treatment with Zoledronic acid or Tenofovir Switching in HIV-Infected

Phase 1

Conditions: low bone mineral density - HIV
MedDRA version: 16.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2013-003359-39-ES

Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 84

Inclusion Criteria

1. provision of written, informed consent
2. HIV infected adult ?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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

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 (total testosterone/oestrogen 25% above upper normal limit); hypothyroidism (low T4 and elevated TSH); hyperparathyroidism (elevated parathyroid hormone); inhaled fluticasone in a patient receiving ritonavir; prednisolone ?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 (defined above), 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