Osteoporosis and Activation Study of the Immune System in HIV

Osteoporosis and Activation Study of the Immune System in HIV - OASIS-HIV

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40958

Enrollment

Registered

2014-06-25

Start date

2014-07-11

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis Porous bones

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
• the level of T cell activation will be compared between the HIV-infected patients with osteoporosis/ osteopenia and those without osteoporosis/ osteopenia.	—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results