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

This study has been completed.
Sponsor:
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
  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.

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders 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
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

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
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Hopital Lariboisière:
male patients
treated by TRUVADA® or VIREAD® for more than 60 months

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Emtricitabine
Fluorides
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 05, 2016