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

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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LKH Graz West, Graz, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Femoral Neck and Spine (L1-4) T-score

Time frame: 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 outcomes

Observed T-score < -2 (yes/no) for femoral neck and spine (L1-4)

Time frame: Day 1

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

Time frame: Day 1

Observed T-score for femoral neck and spine will be used to further characterize low BMD.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: May 9, 2013
Registry last updated: Oct 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed