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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT02401269
Eligibility Criteria:
Inclusion Criteria:
Malawian men and women ages 18-70 who are HIV positive and on ART for at least 6 months on standard therapy (1st line, 2nd line or 3rd line). The HIV viral load at time of enrollment must be suppressed confirmed by HIV DNA PCR in the last 60 days.
Exclusion Criteria:
All patients with risk factors that result in endothelial dysfunction and atherosclerosis will be excluded based on the following exclusion criteria. The rationale behind this is to isolate the effects of virally suppressed HIV on endothelial activity.
1. Presence of HIV viral load in the last 60 days
2. History of diagnosed Diabetes Mellitus
3. Fasting blood sugar \>110 at time of enrollment determined by glucose on chemistry profile
4. Uncontrolled Hypertension defined as systolic blood pressure \> or equal to 140 and or diastolic \>100 mmHg at time of enrollment
5. AST or ALT \>200 within the last 30 days. If not obtained in this interval, a baseline AST/ALT will be obtained
6. Renal Failure at time of recruitment (Gfr. \<60ml/min/1.73) based on Cockcroft Gault equation.
7. History of myocardial infarction, peripheral vascular disease, cerebrovascular disease. These will also be assessed clinically at the time of enrollment
8. Health condition that would place patient at a health risk for perfusion ischemia during EndoPAT, FMD, CIMT measurement.
9. Current tobacco use or history of tobacco use in the last 90 days
10. Platelet count less than 100 at time of enrollment
11. History of active brain mass/lesion
12. Gastrointestinal bleeding in last 12 months
13. History of hemorrhagic stroke
14. Major life threatening bleeding in the last 12 months
15. Patients considered to be a high bleed risk based on physician assessment
16. History of medication noncompliance in last 3 months
17. Pregnancy
18. Contraindications to aspirin
* Previous allergic reaction to aspirin or similar medications to aspirin
* Asthma with nasal congestion or nasal polyps
* Bleeding disorders (inherited or acquired)
* Chicken pox
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02401269
Study Brief:
Protocol Section:
NCT02401269