A Study of Bone Mineral Density in HIV Infected Subjects

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 480

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

• 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 ARV regimen for = 3 years are allowed (withinclass change of agents other than TDF within 3 years of study entry
are permitted as specified):
- a 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 a 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 to another non-TDF 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 nonboosted 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 (i.e., surgical removal of the ovaries, resulting in surgical menopause” and occurring at the age at which the procedure was performed) 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 (i.e., spontaneous menopause,” which occurs in the United States at a mean age of 51.5 years).

• Documented spontaneous menopause defined as:
- Age = 54 years with the absence of normal menses defined as serum FSH level elevated to within the post menopausal range based on the laboratory reference range where the hormonal assay is performed.
- Or Age < 54 years and with the absence of normal menses defined as a negative serum or urine human chorionic gonadotropin (hCG) with concurrently elevated serum FSH level in the post-menopausal range, depressed estradiol (E2) level in the post menopausal range, and absent serum progesterone level, based on the laboratory reference ranges where the hormonal assays
are performed.

• Adequate records available to evaluate medical history for the 3 years prior to study entry, including:
- Prior ARV regimens and other medications
- Risk factors for osteoporosis and osteopenia
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 456
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.

• Have a contraindication to dual-energy X-ray absorptiometry (DEXA) scans

• Have a history of osteoporosis before initiating highly active antriretroviral therapy
(HAART)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 Objective: Not applicable;Primary end point(s): The femoral neck T-score and spine (L1-4) T-score are the primary endpoints to characterize<br>the low BMD (both as continuous measures).;Timepoint(s) of evaluation of this end point: The primary endpoint will be assessed for all subjects who have results from the required BMD scan at the single study visit.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints for characterizing low BMD are:<br>• Observed T-score < -2 (yes/no) for femoral neck and spine (L1-4)<br>• Observed -2 = T-score < -1 (yes/no) 1 for femoral neck and spine (L1-4);Timepoint(s) of evaluation of this end point: The secondary endpoints will be assessed for all subjects who have results from the required BMD scan at the single study visit.