A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects

Completed

• Conditions: HIV Infections

• Registration Number: NCT01850212
• Lead Sponsor: Gilead Sciences

Brief Summary

A Phase 4 study is to characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based regimen

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-09
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-30
• Last Update Posted: 2014-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

• Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.

• HIV-1 infected subjects regardless of race or ethnicity

• Use of one of the following taken as a stable, continuous, NRTI-containing antiretroviral (ARV) regimen for ≥ 3 years are allowed (within-class change of agents other than TDF within 3 years of study entry are permitted as specified):

  • TDF plus PI/r-containing regimen including subjects who switched from one TDF plus PI/r regimen to another TDF plus PI/r regimen
  • a TDF plus non-PI/r-containing regimen including subjects who switched from one TDF plus non-PI/r regimen to another TDF plus non-PI/r regimen
  • a Non-TDF NRTI plus a PI/r-containing regimen including subjects who switched from one non-TDF NRTI plus PI/r regimen to another non-TDF NRTI regimen plus PI/r regimen
  • a Non-TDF NRTI plus a non-PI/r-containing regimen including subjects who switched from one non-TDF NRTI plus non-PI/r regimen to another non-TDF NRTI regimen plus non-PI/r regimen

• Of note, subjects in the non-TDF groups must have never taken a regimen that includes TDF (including previous exposure to TDF for pre-exposure prophylaxis (PrEP))

• Subjects included in the TDF groups must have always taken a regimen that includes TDF. Non-PI/r agents include non-nucleoside reverse transcriptase inhibitors (NNRTIs), integrase inhibitors, triple nucleoside inhibitors and non-boosted protease inhibitors

• Male subjects must be ≥ 50 years of age

• Female subjects must be postmenopausal. Menopause can be assumed to have occurred in a woman when there is either appropriate medical documentation of prior complete bilateral oophorectomy or permanent cessation of previously occurring menses > 12 months as a result of ovarian failure or bilateral oophorectomy with documentation of hormonal deficiency by a certified healthcare provided

• Adequate records available to evaluate medical history for the 3 years prior to study entry

Exclusion Criteria

• Subject has a contraindication to dual-energy X-ray absorptiometry (DEXA) scans
• Subject has a history of osteoporosis before initiating Highly Active Antiretroviral Treatment (HAART)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Femoral Neck and Spine (L1-4) T-score	Day 1	Femoral neck and spine (L1-4) T-score will be used to characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based regimen relative to those on any non-TDF-based regimen for HIV infection.

Secondary Outcome Measures

Name	Time	Method
Observed -2 ≤ T-score < -1 (yes/no) for femoral neck and spine (L1-4)	Day 1	Observed T-score for femoral neck and spine will be used to further characterize low BMD.
Observed T-score < -2 (yes/no) for femoral neck and spine (L1-4)	Day 1	Observed T-score for femoral neck and spine will be used to further characterize low BMD.

Trial Locations

Locations (73)

LKH Graz West; 🇦🇹 Graz, Austria

Medizinische Universitaet Innsbruck; 🇦🇹 Innsbruck, Austria

AKh Allgemeines Krankenhaus der Stadt Linz GmbH; 🇦🇹 Linz, Austria

Otto Wagner Spital; 🇦🇹 Vienna, Austria

Medizinische Universitat Wien; 🇦🇹 Vienna, Austria

CHU Saint-Pierre University Hospital; 🇧🇪 Brussels, Belgium

CUB Hopital Erasme- Free University of Brussels; 🇧🇪 Brussels, Belgium

Cliniques Universitaires St. LUC (UCL); 🇧🇪 Brussels, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Centre Hospitalier Universitaire Sart Tilman Liège; 🇧🇪 Liege, Belgium

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