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:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT03598556
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Willingness and availability to engage in study activities for the duration of the study
* Documented HIV-1 infection (confirmed by Western blot)
* ART naïve at the time of enrollment
* Eligible to initiate ART (TDF/3TC/EFV) within 1 month
* Ability to take oral medication and be willing to adhere to the mediation regimen
* For females of reproductive potential: use of highly effective contraception
Exclusion Criteria:
* Pregnancy or breastfeeding
* AIDS-defining illness within 2 weeks of entry
* Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)
* Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)
* Patients with a history of injection drug usage
* Known history of osteoporosis, osteoporotic fracture, or other metabolic/inherited bone disorder
* History of treatment with prescription therapies for osteoporosis (for example: bisphosphonates, denosumab, teriparatide, selective estrogen receptor modifying agents, active forms of vitamin D).
* Unwillingness to discontinue previous vitamin D supplementation, if any, at time of enrollment
* Rheumatoid arthritis
* Malabsorption or inflammatory bowel disease
* Hyperparathyroidism, hypercalcemia, or hypocalcemia
* History of kidney stones
* Poorly controlled thyroid disease
* History of neuromuscular disorder/movement disorder, stroke or seizures
* History of significant neurocognitive disorders (including mental health conditions or dementia)
* Glucocorticoids, estrogen, testosterone, or anticonvulsant use within the past six months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03598556
Study Brief:
Protocol Section:
NCT03598556