Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT01850212
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01850212
Study Brief:
Protocol Section:
NCT01850212