Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

Study Overview
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Brief Summary
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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.

Official Title
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Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

Conditions
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HIV, Osteopenia, Osteoporosis, HIV Infections

Intervention / Treatment
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* Drug: Raltegravir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Raltegravir<br> | Drug: Raltegravir<br>* Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.<br>* Other names: MK-0518;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Bone Mineral Density (BMD) of Lumbar Spine and Hips | Percent Change in Bone Mineral Density of Lumbar Spine and Hips from Baseline to Weeks 48 and 96 | from Baseline to Weeks 48 and 96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With HIV Viral Load <50 Copies/mL | Plasma HIV viral load remained <50 copies/mL | from Baseline to Week 96 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV+, Raltegravir, Tenofovir, osteopenia, osteoporosis, bone markers, treatment experienced