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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Bone mineral density [ Time Frame: From baseline to week 48 ] [ Designated as safety issue: No ]
- t-score change [ Time Frame: From baseline to week 48 ] [ Designated as safety issue: No ]
- viral load [ Time Frame: Evolution from baseline to week 48 ] [ Designated as safety issue: Yes ]
- CD4 T lymphocytes count [ Time Frame: Evolution from baseline to week 48 ] [ Designated as safety issue: No ]
- Resistance test [ Time Frame: If virological failure occurs ] [ Designated as safety issue: No ]
- Lipid parameters (total, HDL-, LDL-cholesterol and triglyceride levels) [ Time Frame: Evolution from baseline to week 48 ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: From baseline to week 48 ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2010|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Switch from tenofovir to abacavir
Drug: Switch from tenofovir to abacavir
Switch from tenofovir to abacavir
Other Name: Abacavir
No Intervention: tenofovir
Follow same ART regimen
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-sectional published studies. The analysis includes data from 884 HIV-infected patients and 654 HIV-uninfected controls. Sixty-seven percent of HIV population had reduced bone mineral density (BMD), of whom 15% had osteoporosis (OR of 6.4 and 3.7, respectively, compared with HIV-uninfected controls).
In the same meta-analysis, when authors evaluated the role of antiretroviral therapy (ART) on BMD, comparing 202 antiretroviral-naive with 824 ART-treated patients, patients on treatment had a 2.5-fold increased odds of prevalent reduced BMD and osteoporosis. And finally, when 410 non-protease inhibitor (PI)-treated HIV patients were compared with 791 patients receiving a PI-containing regimen, those on PIs had increased odds of reduced BMD and osteoporosis.
As well, other studies support data of an impaired BMD in HIV-infected patients after starting antiretroviral therapy. These results let us confirm that HIV itself and antiretroviral therapy contribute to decrease the BMD.
However, most of studies have not found any consistent drug-specific association with bone loss and controversial data with respect the effect of PIs have been published. The more evident finding with respect to this issue is the more pronounced decrease of BMD in patients during the first weeks of receiving a tenofovir (TDF)-containing regimen, probably by the effect of TDF on phosphorus balance and vitamin D metabolism.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153217
|Lluita contra la SIDA Foundation|
|Badalona, Barcelona, Spain, 08916|
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08041|