A Phase 3 interventional study of Switch from tenofovir to abacavir in HIV, sponsored by Germans Trias i Pujol Hospital. Completed at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-17.
Sponsored by Germans Trias i Pujol Hospital · Phase 3, Interventional, and Treatment
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 finding with respect to this issue is the more pronounced decrease of bone mineral density (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.
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.
Germans Trias i Pujol Hospital is the lead sponsor of 87 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Switch from tenofovir to abacavir
Drug: Switch from tenofovir to abacavir
Follow same ART regimen
Switch from tenofovir to abacavir
Also known as: Abacavir
Bone mineral density
Time frame: From baseline to week 48
t-score change
Time frame: From baseline to week 48
viral load
Time frame: Evolution from baseline to week 48
CD4 T lymphocytes count
Time frame: Evolution from baseline to week 48
Resistance test
Time frame: If virological failure occurs
Lipid parameters (total, HDL-, LDL-cholesterol and triglyceride levels)
Time frame: Evolution from baseline to week 48
Adverse Events
Time frame: From baseline to week 48
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Germans Trias i Pujol Hospital