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

Study Overview
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Brief Summary
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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

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

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Male (≥ 50 years), TDF<br>Male (≥ 50 years of age) on regimens containing tenofovir disoproxil fumarate (TDF) | |
| Male (≥ 50 years of age), Non-TDF<br>Male (≥ 50 years of age) on non-TDF (tenofovir disoproxil fumarate) based nucleoside reverse transcriptase inhibitors (NRTIs) | |
| Female (Postmenopausal), TDF<br>Female (postmenopausal) on regimens containing tenofovir disoproxil fumarate (TDF) | |
| Female (Postmenopausal), Non-TDF<br>Female (postmenopausal) on non-TDF (tenofovir disoproxil fumarate) based NRTIs | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femoral Neck and Spine (L1-4) T-score | 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. | Day 1 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Experienced, Male greater than or equal to 50 years, Female postmenopausal