Clinical Trials Logo
  1. Home
  2. HIV Seropositivity
  3. NCT01813292

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

HIV Seropositivity Clinical Trial

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.

Clinical Trial Summary

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.

Clinical Trial 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). ;

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01813292
Study type Observational
Source Hopital Lariboisière
Contact
Status Completed
Phase N/A
Start date May 2013
Completion date July 2014
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03661203 - Investigation of the Psychosocial Factors Responsible for the Late Recourse to HIV Testing Within MSM
Completed NCT00381212 - A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent. Phase 1/Phase 2
Not yet recruiting NCT05983536 - The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)
Recruiting NCT04832477 - Assessing the PrEP Care Cascade Among Black Men and Transwomen in the Southeastern US N/A
Active, not recruiting NCT04044586 - HIV and HCV Infections in 2 Communes From the Battambang Province, Cambodia: Prevalence Rates, Viral Strains, and Unsafe Injection Practices (12352 ANRS ROK INVEST)
Completed NCT03218839 - Evaluation of the PrePex Device for Rapid Scale-up of VMMC, Phase 3 Field Implementation Trial With HIV + Adult Males N/A
Active, not recruiting NCT00797030 - Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus Phase 4
Recruiting NCT04088916 - Proviral DNA as a Target for HIV-1 Resistance Analysis
Completed NCT03367130 - Improving Clinic Attendance for Medication Collection Among HIV Positive Individuals in Nepal N/A
Completed NCT04849767 - National Survey About Trajectory and Life Conditions of HIV Trans People in France
Completed NCT05674682 - Seroincidence Study Among Men Who Have Sex With Men and Transgender Women - The ImPrEP Seroincidence Study N/A
Recruiting NCT05174234 - Precariousness and Sexual Vulnerability of People From Haiti Living With or Without HIV in French Guiana
Completed NCT00130819 - Comparison of HIV Clinic-based Treatment With Buprenorphine Versus Referred Care in Heroin-dependent Participants Phase 2
Active, not recruiting NCT04706624 - Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics N/A
Recruiting NCT03858478 - Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST Phase 4
Completed NCT02154971 - Assessment of Age-related Hearing Loss in HIV-1 Patients
Recruiting NCT03311945 - Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM Phase 3
Recruiting NCT03333083 - Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen Phase 3
Recruiting NCT03795415 - ANRS12373 GUNDO SO - Evaluation of an Empowerment Program for WLHIV in Mali
Completed NCT01881971 - Statins for Pulmonary and Cardiac Complications of Chronic HIV - Coordinating Center Early Phase 1