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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT06544733
Eligibility Criteria:
Key Inclusion Criteria:
* Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 24 weeks before and at screening.
* Receiving BVY for ≥ 24 weeks prior to screening.
Key Exclusion Criteria:
* Prior use of, or exposure to LEN, GS-1720, or GS-4182.
* History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen.
* Documented integrase strand-transfer inhibitor (INSTI) resistance, specifically, resistance-associated mutations (RAMs) E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene.
* Prior use of any long-acting (LA) parenteral antiretrovirals (ARV) such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.
* Any of the following laboratory values at screening:
* Clusters of differentiation 4 (CD4) cell count \< 200 cells/mm\^3 at screening
* Glomerular filtration rate \< 60 mL/min according to the Modification of Diet in Renal Disease formula
* Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 1.5 × upper limit of normal (ULN)
* Direct bilirubin \> 1.5 × ULN
* Platelets count \< 50,000 cells/mm\^3
* Hemoglobin \< 8.0 g/dL
* Active or occult hepatitis B virus (HBV) infection.
* Active hepatitis C virus (HCV).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06544733
Study Brief:
Protocol Section:
NCT06544733