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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT03502005
Eligibility Criteria:
Inclusion Criteria:
* HIV positive
* On a stable antiretroviral regimen consisting of ATRIPLA® for at least the 6 consecutive months preceding Screening Visit.
* Plasma HIV-1 RNA concentrations at undetectable levels for at least 6 consecutive months prior to the screening visit and have HIV RNA\< 50 copies/mL at the Screening Visit.
* Estimated GFR ≥30mL/min according to the Cockcroft-Gault formula for creatinine clearance.
* Hepatic transaminases (AST and ALT) ≤5x upper limit of normal (ULN)
* Total bilirubin ≤1.5 mg/dL, or normal direct bilirubin.
* Adequate hematologic function (hemoglobin ≥ 8.5g/dL; platelets ≥ 50,000/mm3; absolute neutrophil count ≥1,000/mm3)
* Female subjects of reproductive potential using a reliable and consistent method of birth control for at least three months prior to study dosing. Male subjects should use condoms when engaging in intercourse of reproductive potential.
* The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
Exclusion Criteria:
* A new AIDS-defining condition diagnosed within 30 days prior to screening.
* Individuals with decompensated cirrhosis. (i.e. ascites, encephalopathy, etc.)
* Pregnancy
* A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible but must not have received any systemic therapy for KS within 30 days prior to baseline.
* Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline.
* Life expectancy \< 1 year.
* Subject participation in any clinical trial without prior approval from the Investigator.
* Concomitant use of disallowed agents from Table 2
* Participation in any other investigation study 30 days prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03502005
Study Brief:
Protocol Section:
NCT03502005