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
  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

Resource links provided by NLM:


Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153217

Locations
Spain
Lluita contra la SIDA Foundation
Badalona, Barcelona, Spain, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Sponsors and Collaborators
Germans Trias i Pujol Hospital
  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 April 16, 2014