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 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT02750059
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old
2. Have protocol-defined acute HIV-1 infection (Tested 4th generation HIV enzyme immunoassay \[EIA\] negative and NAT positive or tested 4th generation HIV EIA positive, negative by less sensitive EIA and nucleic acid testing \[NAT\] positive)
3. Be part of the SEARCH 010/RV 254 study
4. Ability and willingness to start ART immediately after diagnosis
5. Understand the study and sign informed consent form. Persons who cannot read will have the consent form read to them by a member of the study staff and may then give informed consent by using making a thumb print
6. Availability for follow-up for the duration of the planned study
7. Systolic blood pressure ≥ 110 mmHg
8. Agree to undergo lumbar puncture at weeks 0, 48 and 72
9. Ability and willingness to provide informed consent
Exclusion Criteria:
1. Pregnancy (current or within the last 6 months) or breastfeeding
2. Uncontrolled hypertension
3. Use of thiazolidinediones or other angiotensin receptor blockers class \[losartan, irbesartan, olmesartan, valsartan, candesartan (washout permitted)\]
4. Screening laboratory values: absolute neutrophil count (ANC) \< 750 cells/mm3, hemoglobin \<10 gm/dL creatinine clearance\<30mL/min (estimated by the Cockcroft-Gault equation using ideal body weight)
5. Known renal artery stenosis
6. Known cirrhosis or severe liver disease
7. Unstable coronary artery disease/angina or decompensated congestive heart failure
8. Any history of intolerance to any angiotensin II receptor blocker (ARB)
9. Need for ongoing potassium supplementation
10. Any contraindication to lumbar puncture such as history of bleeding diathesis or known cerebral mass lesion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02750059
Study Brief:
Protocol Section:
NCT02750059