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:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT02652793
Eligibility Criteria:
Inclusion Criteria:
* Human immunodeficiency virus-1-infected subjects with age ≥18 years old
* Hip or spine T-scores between \< -1.0 and \>-2.5 by dual-energy X-ray absorptiometry (in the previous 24 weeks)
* Stable antiretroviral treatment based on tenofovir and lamivudine or emtricitabine and boosted protease inhibitor for at least 24 weeks.
* Having plasma human immunodeficiency virus-1 RNA \<50 copies/mL for at least the previous 24 weeks, including at least two samples.
Exclusion Criteria:
* Pregnancy, breast-feeding status or plans for pregnancy in the short term
* Primary genotypic resistance mutations and/or previous virological failures to atazanavir or lamivudine/emtricitabine
* Chronic hepatitis B infection
* Patients with indication for therapy for the prevention of bone fractures
* 25-OH vitamin D deficiency (\< 10ng/mL)
* Hypogonadism (low total testosterone according to local reference range)
* Hypothyroidism (low T4 and increased thyroid stimulating hormone levels according to local reference ranges)
* Hyperparathyroidism (increased parathyroid hormone level with hypercalcaemia according to local reference ranges)
* Having received oral corticosteroids or inhaled fluticasone (daily doses higher than 5 mg/d prednisone equivalent for 3 months or more)
* Using anti-resorptive therapy (Calcium and vitamin D supplements are encouraged but not mandated)
* Body mass index lower than 19
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02652793
Study Brief:
Protocol Section:
NCT02652793