Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-04-30

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.

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Detailed Description

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Conditions

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HIV Osteopenia Osteoporosis HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Raltegravir

Group Type EXPERIMENTAL

Raltegravir

Intervention Type DRUG

Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.

Interventions

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Raltegravir

Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.

Intervention Type DRUG

Other Intervention Names

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Isentress MK-0518

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No