Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

Phase 4

Completed

• Conditions: HIV; Osteopenia; Osteoporosis; HIV Infections
• Interventions: Drug: Raltegravir

• Registration Number: NCT00939874
• Lead Sponsor: St Vincent's Hospital, Sydney

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Study Start: 2009-10
• Primary Completion: 2012-06
• Study Completion: 2014-04
• Results First Submitted: 2015-01-13
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-28
• Last Update Submitted: 2015-05-28
• Results First Posted: 2015-06-12
• Last Update Posted: 2015-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Raltegravir	Raltegravir	-

Primary Outcome Measures

Name	Time	Method
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips	from Baseline to Weeks 48 and 96	Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With HIV Viral Load <50 Copies/mL	from Baseline to Week 96	Plasma HIV viral load remained \<50 copies/mL

Trial Locations

Locations (4)

Holdsworth Medical Practice; 🇦🇺 Sydney, New South Wales, Australia

St Vincents Hospital; 🇦🇺 Sydney, New South Wales, Australia

East Sydney Doctors; 🇦🇺 Sydney, New South Wales, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia