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 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT03405935
Eligibility Criteria:
Key Inclusion Criteria:
* Currently receiving an antiretroviral regimen of E/C/F/TAF FDC (or emtricitabine \[FTC\]/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 \[NCT02616783\]) for ≥ 3 months
* Documented plasma HIV-1 ribonucleic acid (RNA) \< 50 copies/mL during treatment with E/C/F/TAF (or FTC/TDF + 3rd agent if currently or previously participated in Study GS-US-292-1826 \[NCT02616783\]) for the last 2 visits preceding the screening visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL)
* Adequate renal function, an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
Key Exclusion Criteria:
* An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
* Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
* Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT03405935
Study Brief:
Protocol Section:
NCT03405935