Clinical trial NCT00939874: Switch From Tenofovir to Raltegravir for Low Bone Mineral Density
Official title: Switch From Tenofovir to Raltegravir for Low Bone Mineral Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Osteopenia
Osteoporosis
HIV Infections
Keywords: HIV+
Raltegravir
Tenofovir
osteopenia
osteoporosis
bone markers
treatment experienced
Lead sponsor: St Vincent's Hospital, Sydney
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Holdsworth House Medical Practice
name: The Alfred
First posted: 2009-07-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 to another HIV medication raltegravir.

Hypothesis:That Bone Mineral Density (BMD) will improve in osteopenic or osteoporotic patients switching from ART including tenofovir disoproxil fumarate (TDF) and a ritonavir-boosted protease inhibitor (r/PI) to ART including RAL+r/PI.


Eligibility criteria: Inclusion Criteria:

1. provision of written, informed consent
2. HIV-infected adults at least 18 years of age
3. receiving stable ART including TDF and a r/PI for the previous 6 months
4. no prior PI genotypic resistance or known replication of HIV in patients receiving a PI
5. plasma HIV RNA \< 50 copies/ml for at least the previous 3 months
6. spine or neck of femur t-score ≤ -1.0 (i.e. WHO-defined osteopenia) measured by dual energy x-ray absorptiometry (DEXA)

   Exclusion Criteria:
7. participation in any other clinical trial (unless approved by the study PI)
8. use of TDF for previously active chronic hepatitis B infection
9. receiving or requiring therapy for low BMD (including prior fragility fracture)
10. using oral corticosteroids or inhaled fluticasone
11. virological failure on, or intolerance to, RAL
12. contra-indication to RAL therapy (see appendix 2)
13. breast-feeding
14. pregnancy
15. 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

Primary outcomes:
measure: Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips
timeFrame: from Baseline to Weeks 48 and 96
Secondary outcomes:
measure: Percentage of Participants With HIV Viral Load <50 Copies/mL
timeFrame: from Baseline to Week 96
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: East Sydney Doctors
state: New South Wales
city: Sydney
country: Australia
facility: Holdsworth Medical Practice
state: New South Wales
city: Sydney
country: Australia
facility: St Vincents Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
affiliation: St Vincents Hospital
name: Andrew D Carr, Professor
role: PRINCIPAL_INVESTIGATOR
References: