In this exploratory pilot study, we aim to investigate the role of immune activation in osteoporosis in HIV-infected patients on HAART with proven osteoporosis/ osteopenia in comparison to HIV-infected patients on HAART without osteoporosis/…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• the level of T cell activation will be compared between the HIV-infected
patients with osteoporosis/ osteopenia and those without osteoporosis/
osteopenia.
Secondary outcome
Secondary endpoints:
• the concentration of cytokines involved in the immunopathology of osteoporosis
• the expression of collagen markers
All endpoints will be compared between the HIV-infected patients with
osteoporosis/ osteopenia and those without osteoporosis/ osteopenia.
Background summary
The prevalence of osteoporosis in HIV-infected patients is increased 3.7 fold
compared to non HIV-infected, age-matched individuals. Besides traditional risk
factors, HIV-specific risk factors also seem to play a role, such as Highly
Active Anti-Retroviral Therapy (HAART) and immune activation. Immune activation
has been implicated as the driving force in several non-AIDS defining diseases
which we see nowadays in HIV-infected patients. The level of immune activation
can be measured by investigating T cell activation and other cellular and
soluble markers. In osteoporosis patients, T cell activation and the presence
of certain cytokines has not been studied extensively. By examining the level
of T cell activation in HIV-infected patients with osteoporosis, compared to
HIV-infected patients without osteoporosis, a better understanding of the
contribution of immune activation to osteoporosis can be studied.
Study objective
In this exploratory pilot study, we aim to investigate the role of immune
activation in osteoporosis in HIV-infected patients on HAART with proven
osteoporosis/ osteopenia in comparison to HIV-infected patients on HAART
without osteoporosis/ osteopenia.
Study design
A single visit, cross-sectional exploratory pilot study.
Study burden and risks
Single visit study, with blood draw of 3 vials, a total of 27ml. Subjects will
not benefit individually from participating in this study. However,
group-related benefits include an understanding of the level of T cell
activation and immune cytokine expression related to the presence of
osteoporosis in HIV-infected patients.
Heidelberglaan 100
Utrecht 3508GA
NL
Heidelberglaan 100
Utrecht 3508GA
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47918.041.14 |