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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT02815566
Eligibility Criteria:
Inclusion Criteria:
1. Biological female aged 40-60
2. Documented HIV-1 infection
3. Peri-menopausal ( as documented by history).
4. Signed Informed Consent Form and willing to comply with the protocol.
5. Receiving a cART regimen containing a ritonavir boosted PI (darunavir, atazanavir, lopinavir,) or an NNRTI (efavirenz, nevirapine or rilpivirine) or an integrase inhibitor (dolutegravir or raltegravir or elvitegravir) in combination with TDF-FTC for \> 24 weeks.
6. Stable viral suppression (plasma HIV-RNA\<50 copies/mL for \> 24 weeks). Single viral blip \<500/ml allowed if re-suppresses.
7. If of childbearing potential, is using effective birth control methods and is willing to continue during the trial.
8. Women will be assessed for vitamin D and calcium dietary intake; if inadequate for age, supplements will be recommended.
Exclusion Criteria:
1. HIV-2
2. High 10-year fracture risk at baseline ( \> 20%) based on country specific FRAX
3. Current treatment with active bone medications- bisphosphonates, denosumab, calcitonin, raloxifene, teriparatide, strontium
4. Current use of systemic steroids ( inhaled steroids permitted) or chemotherapeutic agents
5. Acute viral hepatitis
6. Chronic hepatitis C with liver transaminases \>5 x ULN or expected to require treatment for hepatitis C during the trial period.
7. Any investigational ARV within 30 days.
8. Dialysis or renal insufficiency (creatinine clearance \< 50ml/min)
9. History of decompensated liver disease (AST or ALT≥5x the upper limit of normal (ULN) or ALT ≥ 3 x ULN and bilirubin ≥ 1.5 x ULN with \> 35% direct bilirubin), or the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices.
10. Pregnant or breastfeeding
11. Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 amylase, creatinine phosphokinase, or lipid elevation.
12. Any condition (including illicit drug use or alcohol abuse) or lab results which, in the investigator's opinion, interfere with assessments or completion of the trial.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
60 Years
Study:
NCT02815566
Study Brief:
Protocol Section:
NCT02815566