Study of Oral Weekly GS-1720 and GS-4182 Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed

A vizsgálat adatai

Ki végzi

Gilead Sciences Inc.

Azonosító

NCT06544733EU 2024-511054-50-00

A regiszteradat frissítve

2025. április 2.

Eredeti leírás

Phase 2: To evaluate the efficacy of switching to oral weekly GS-1720 in combination with GS-4182 versus continuing bictegravir/emtricitabine/tenofovir alafenamide (BVY; coformulated, Biktarvy®) in virologically suppressed PWH at Week 24 Phase 3: To evaluate the efficacy of switching to oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48A teljes eredeti leírásKevesebb

An Operationally Seamless Phase 2/3, Randomized, Active -Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Virologically Suppressed People With HIV-1

Phase 2: To evaluate the efficacy of switching to oral weekly GS-1720 in combination with GS-4182 versus continuing bictegravir/emtricitabine/tenofovir alafenamide (BVY; coformulated, Biktarvy®) in virologically suppressed PWH at Week 24 Phase 3: To evaluate the efficacy of switching to oral weekly GS-1720/GS-4182 fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48

Bevonási feltételek: Participants must meet all of the following inclusion criteria to be eligible for participation in this study: Participants 18 years of age or older and able to understand and give written informed consent; Participants assigned male at birth and participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception; Documented plasma HIV-1 RNA < 50 copies/mL for ≥ 24 weeks before and at screening; Receiving BVY for ≥ 24 weeks prior to screening.

Kizáró feltételek: Participants who meet any of the following exclusion criteria are not eligible to be enrolled in this study: Prior use of, or exposure to LEN, GS-1720, or GS-4182; Have been treated within 6 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic [at least 4 weeks] systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies); Participation in any other clinical study, including observational studies, without prior approval from the Sponsor is prohibited while participating in this study; Participants with plans to breastfeed during the study period and within 60 days following the last dose of study drug; Serious illness requiring hospitalizations within 30 days prior to screening and during the screening period or active malignancy requiring acute systemic treatment; Requirement for ongoing therapy with or prior use of any prohibited medications; Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements, including medical history of psychotic disorder and/or use of antipsychotic medications prescribed for psychosis; Prior use of any Long Acting (LA) parenteral antiretrovirals (ARVs) such as monoclonal antibodies (mAbs) or broadly neutralizing antibodies (bNAbs) targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine; Active hepatitis C virus (HCV) defined as detectable HCV RNA. Note: Participants with prior/inactive HCV infection (defined as undetectable HCV RNA) may enroll; Known hypersensitivity to the study drug, its metabolites, or formulation excipient; History of virologic failure while on an integrase strand-transfer inhibitor (INSTI)-based regimen; Active tuberculosis infection; Active or occult hepatitis B virus (HBV) infection as defined below (regardless of other HBV serologic results). Participants found to be susceptible to HBV infection should be recommended to receive an HBV vaccination. a) Hepatitis B surface antigen positive (HBsAg+) (or) b) Hepatitis B core antibody positive (HBcAb+) and hepatitis B surface antibody negative (HBsAb-); Moderate/severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding); Positive serum pregnancy test at screening or positive pregnancy test at Day 1; Any of the following laboratory values at screening: a) CD4 cell count < 200 cells/mm3 at screening b) Glomerular filtration rate < 60 mL/min according to the Modification of Diet in Renal Disease formula c) Hepatic transaminases (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 1.5 × upper limit of normal (ULN) d) Direct bilirubin > 1.5 × ULN e) Platelets count < 50,000 cells/mm3 f) Hemoglobin < 8.0 g/dL; Current alcohol or substance use judged by the investigator to potentially interfere with participant study compliance; Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator; Documented 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.

ClinicalTrials.gov NCT06544733 · EU CTIS 2024-511054-50-00