NCT01153217

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for phase_3 hiv

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_3 hiv

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

October 17, 2012

Status Verified

October 1, 2012

Enrollment Period

1.9 years

First QC Date

June 29, 2010

Last Update Submit

October 16, 2012

Conditions

HIV

Keywords

TenofovirHIV-infectionBMDOsteoporosisOsteopenia

Outcome Measures

Primary Outcomes (2)

  • Bone mineral density

    From baseline to week 48

  • t-score change

    From baseline to week 48

Secondary Outcomes (5)

  • viral load

    Evolution from baseline to week 48

  • CD4 T lymphocytes count

    Evolution from baseline to week 48

  • Resistance test

    If virological failure occurs

  • Lipid parameters (total, HDL-, LDL-cholesterol and triglyceride levels)

    Evolution from baseline to week 48

  • Adverse Events

    From baseline to week 48

Study Arms (2)

Abacavir

EXPERIMENTAL

Switch from tenofovir to abacavir

Drug: Switch from tenofovir to abacavir

tenofovir

NO INTERVENTION

Follow same ART regimen

Interventions

Switch from tenofovir to abacavirDRUG

Switch from tenofovir to abacavir

Also known as: Abacavir
Abacavir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lluita contra la SIDA Foundation

Badalona, Barcelona, 08916, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

Location

Related Publications (1)

  • Negredo E, Domingo P, Perez-Alvarez N, Gutierrez M, Mateo G, Puig J, Escrig R, Echeverria P, Bonjoch A, Clotet B. Improvement in bone mineral density after switching from tenofovir to abacavir in HIV-1-infected patients with low bone mineral density: two-centre randomized pilot study (OsteoTDF study). J Antimicrob Chemother. 2014 Dec;69(12):3368-71. doi: 10.1093/jac/dku300. Epub 2014 Aug 13.

    PMID: 25125679DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeOsteoporosisBone Diseases, Metabolic

Interventions

abacavir

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dra. Eugenia Negredo

Study Record Dates

First Submitted

June 29, 2010

First Posted

June 30, 2010

Study Start

July 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

October 17, 2012

Record last verified: 2012-10

Locations

ES(2)