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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sílvia Gel, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT01153217
First received: June 29, 2010
Last updated: October 16, 2012
Last verified: October 2012

June 29, 2010
October 16, 2012
July 2010
June 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01153217 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
Drug: Switch from tenofovir to abacavir
Switch from tenofovir to abacavir
Other Name: Abacavir
  • Experimental: Abacavir
    Switch from tenofovir to abacavir
    Intervention: Drug: Switch from tenofovir to abacavir
  • No Intervention: tenofovir
    Follow same ART regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Adult patients (=/+18 years old) having a diagnosis of HIV-1 infection.
  2. Current HAART including tenofovir plus emtricitabine/lamivudine plus a PI, a NNRTI or raltegravir started at least 12 months before.
  3. T-score ≤-2 measured by DEXA (within the last 6 months).
  4. Maintained undetectable plasma HIV-1 RNA (VL < 50 copies/mL) for at least 12 months.
  5. Absence of suspected or documented resistance mutations in the RT associated to abacavir.
  6. Voluntary written informed consent.

Exclusion Criteria:

  1. History of intolerance, toxicity or virological failure to abacavir.
  2. HLA B*5701 positive.
  3. Secondary osteoporosis/osteopenia (vitamin D or testosterone deficit, thyroid disease, …)
  4. Therapy with biphosphonates within the last 12 months.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01153217
OSTEOTENOFOVIR
No
Sílvia Gel, Germans Trias i Pujol Hospital
Germans Trias i Pujol Hospital
Not Provided
Not Provided
Germans Trias i Pujol Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP