Status:
COMPLETED
Multicentre Study To Assess Changes In Bone Mineral Density Of The Switch From Tenofovir To Abacavir In Hiv-1-Infected Subjects With Loss Of Bone Mineral Density
Lead Sponsor:
Germans Trias i Pujol Hospital
Conditions:
HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Most of studies have not found any consistent drug-specific association with bone loss and controversial data with respect the effect of protease inhibitors (PIs) have been published. The more evident...
Detailed Description
The prevalence of osteoporosis in HIV-infected patients could be more than three times greater compared with HIV-uninfected subjects, according to the results of a meta-analytical review of cross-sect...
Eligibility Criteria
Inclusion
- Adult patients (=/+18 years old) having a diagnosis of HIV-1 infection.
- Current HAART including tenofovir plus emtricitabine/lamivudine plus a PI, a NNRTI or raltegravir started at least 12 months before.
- T-score ≤-2 measured by DEXA (within the last 6 months).
- Maintained undetectable plasma HIV-1 RNA (VL \< 50 copies/mL) for at least 12 months.
- Absence of suspected or documented resistance mutations in the RT associated to abacavir.
- Voluntary written informed consent.
Exclusion
- History of intolerance, toxicity or virological failure to abacavir.
- HLA B\*5701 positive.
- Secondary osteoporosis/osteopenia (vitamin D or testosterone deficit, thyroid disease, …)
- Therapy with biphosphonates within the last 12 months.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01153217
Start Date
July 1 2010
End Date
June 1 2012
Last Update
October 17 2012
Active Locations (2)
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1
Lluita contra la SIDA Foundation
Badalona, Barcelona, Spain, 08916
2
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08041