Osteoporosis and Activation Study of the Immune System in HIV

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

-Successful participation in the *A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects* study (UMCU METC number 13-429):
- 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 (within-class 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 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.
- Male subjects must be >= 50 years of age.
- Female subjects must be postmenopausal.
- Adequate records available to evaluate medical history prior to study entry, including:
- prior ARVs and other medications
- risk factors for osteoporosis and osteopenia
- Able to give informed consent, which must be obtained prior to initiation of any study procedures.

Exclusion Criteria

None

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• the level of T cell activation will be compared between the HIV-infected<br /><br>patients with osteoporosis/ osteopenia and those without osteoporosis/<br /><br>osteopenia.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>• the concentration of cytokines involved in the immunopathology of osteoporosis<br /><br>• the expression of collagen markers<br /><br><br /><br>All endpoints will be compared between the HIV-infected patients with<br /><br>osteoporosis/ osteopenia and those without osteoporosis/ osteopenia.</p><br>