Clinical Trials

MainTitle

Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV Patients Treated With Tenofovir +/- Emtricitabine

This study has been completed
Sponsor
Hopital Lariboisière


Information provided by (Responsible Party)
Célia Lloret-Linares, MD PhD, Hopital Lariboisière

ClinicalTrials.gov Identifier
NCT01813292

First received: March 12, 2013
Last updated: November 21, 2016
Last Verified: November 2016
History of Changes
Purpose

Purpose

HIV+ patients are considered at risk for excessive bone fragility. Several factors could contribute: age, male sex, low body mass index (BMI), HIV infection per se, vitamin D deficiency, using tenofovir/a protease inhibitor (time on and/or current use). Tenofovir is used in a backbone of nucleosides/nucleotides analogues with emtricitabine (FTC), licensed as TRUVADA®, or without this analogue, licensed as VIREAD®. FTC closely resembles lamivudine (3TC) but is 5-fluorinated, the daily intake of fluoride is ~15 mg. Fluoride induces bone formation by stimulating osteoblasts, of often impaired bone quality.

The aim of the study is to compare in a cross-sectional design fluoride levels, bone renewal, bone mineral density (BMD) in HIV+ male patients treated by TRUVADA® or VIREAD® for more than 60 months. The patients will be randomly selected, then matched according to age, ethnic origin, BMI.

Condition
HIV Seropositivity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Comparative Study of Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV + Men Being Given Tenofovir With FTC, Emtricitabine (TRUVADA®), or Without (VIREAD®), as Part of Their Antiretroviral Therapy.

Further study details as provided by Célia Lloret-Linares, MD PhD, Hopital Lariboisière:

Primary Outcome Measures

  • Areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius measured by Dual X-ray absorptiometry (DXA) [ Time Frame: ongoing, during the study period, according to the availability of DXA ]

Enrollment: 103
Study Start Date: May 2013
Study Completion Date: July 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Detailed Description:

Fluoride metabolism will be studied by measurement of fluoride in blood and in daily urine, bone remodelling by measurement of P1NP. Dual X-ray absorptiometry (DXA) will be used to determine the areal bone mineral density (aBMD) of the lumbar spine, femoral neck and distal radius. Volumetric BMD (v-BMD) and micro-architecture of distal radius and tibia will be studied using a HR-pQCT scan (Xtreme, Scanco).

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 55 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

HIV+ male patients treated by TRUVADA® or VIREAD® for more than 60 months.

Criteria

Inclusion Criteria:

  • HIV+ patients
  • male patients
  • patients treated by tenofovir+emtricitabine(TRUVADA®) or tenofovir(VIREAD®) for more than 60 months.


Exclusion Criteria:
  • chronic use of fluoroquinolones, antifungal agents, steroids
  • malignancy (current or previous) requiring chemotherapy or radiotherapy

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813292

Locations

France
Hopital Lariboisiere
Paris, France, 75475

Sponsors and Collaborators

Hopital Lariboisière

Investigators

Principal Investigator: Pierre O Sellier, M.D, Ph.D Hopital Lariboisiere, Paris, France
More Information

More Information


Responsible Party: Célia Lloret-Linares, MD PhD, Professor, Medicine A Department,, Hopital Lariboisière  
ClinicalTrials.gov Identifier: NCT01813292   History of Changes  
Other Study ID Numbers: URT-Bone-001  
Study First Received: March 12, 2013  
Last Updated: November 21, 2016  
Individual Participant Data    
Plan to Share IPD: No  

Keywords provided by Célia Lloret-Linares, MD PhD, Hopital Lariboisière:

male patients
treated by TRUVADA® or VIREAD® for more than 60 months

Additional relevant MeSH terms:
HIV Seropositivity
Tenofovir
Emtricitabine
Fluorides

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.