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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Drug: Switch from tenofovir to abacavir |
Phase 3 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 54 |
| Study Start Date: | July 2010 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Abacavir
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
|
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-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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sílvia Gel, Dra. Eugenia Negredo, Germans Trias i Pujol Hospital |
| ClinicalTrials.gov Identifier: | NCT01153217 History of Changes |
| Other Study ID Numbers: | OSTEOTENOFOVIR |
| Study First Received: | June 29, 2010 |
| Last Updated: | October 16, 2012 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by Germans Trias i Pujol Hospital:
|
Tenofovir HIV-infection BMD Osteoporosis Osteopenia |
Additional relevant MeSH terms:
|
Tenofovir Tenofovir disoproxil Abacavir Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on June 18, 2013