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Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

Purpose

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.

Condition

HIV-1-infection

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Currently receiving B/F/TAF for at least 6 months prior to screening. - If plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) measurements in the last 6 months prior to screening are available, all levels must be < 50 copies/mL. - At least one documented HIV-1 RNA level measured between 6 and 12 months (± 2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be < 50 copies/mL. - Plasma HIV-1 RNA levels < 50 copies/mL at screening. - No documented or suspected resistance to BIC (including integrase strand-transfer inhibitor resistant (INSTI-R) mutations T66A/I/K, E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene). - No documented or suspected resistance to tenofovir alafenamide (TAF) (TAF; mutations K65R, K65N, K70E, Q151M or T69 insertion, or ≥ 3 of the following thymidine analog mutations [M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R] in the reverse transcriptase gene). - Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance.

Exclusion Criteria

Positive serum pregnancy test or pregnant at screening or a positive pregnancy test prior to Day 1 randomization. - Breastfeeding (nursing). - Prior use of, or exposure to, LEN. - Active, serious infections (other than HIV-1) requiring parenteral therapy < 30 days prior to randomization. - Active tuberculosis infection. - Acute hepatitis < 30 days before randomization. - Chronic hepatitis B virus (HBV) infection, as determined by either: - Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit. - Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit. - Known hypersensitivity to the study drug, its metabolites, or any formulation excipient. - History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding). - Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant as determined by the investigator. - Active malignancy requiring acute systemic therapy. - Any of the following laboratory values at screening: - Alanine aminotransferase > 5 × upper limit of normal (ULN). - Direct bilirubin > 1.5 × ULN. - Platelets < 50,000/mm^3. - Hemoglobin < 8.0 g/dL. - Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol. - Participation or planned participation in any other clinical study (including observational studies) without prior approval from the sponsor. - 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 dosing requirements. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized in parallel in one of two treatment groups during the Blinded Phase. Participants in both treatment groups will be given the option to continue BIC/LEN FDC treatment during the Open-Label Phase.
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Treatment Group 1: Bictegravir (BIC)/ Lenacapavir (LEN) (75/50 mg) + PTM B/F/TAF	Blinded Phase: Participants will switch from bictegravir/emtricitabine/tenofovir (B/F/TAF) FDC tablets to BIC/LEN (75/50 mg) FDC tablets and placebo-to-match (PTM) B/F/TAF. Participants will receive a 2-day oral loading dose of LEN 600 mg on Day 1 and on Day 2, in addition to the daily doses of BIC/LEN FDC tablet starting on Day 1 up to end of blinded treatment (EBT) visit. Open-label (OL) Phase: Following treatment in the Blinded Phase, participants from Treatment Group 1 will receive BIC/LEN FDC tablets through Week 48 in the Open-label Phase. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets until the conclusion of the OL Phase.	Drug: Bictegravir Tablets administered orally without regard to food Other names: GS-9883 Drug: Lenacapavir Tablets administered orally without regard to food Other names: GS-6207 Drug: Placebo to match B/F/TAF Tablets administered orally without regard to food
Experimental Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LEN	Blinded Phase: Participants will continue with their B/F/TAF (50/200/25 mg) FDC tablets and start PTM BIC/LEN tablets on Day 1. Participants will receive PTM LEN tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2. The blinded phase will continue until the EBT visit. Open Label Phase: Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets until the conclusion of the OL Phase.	Drug: Bictegravir Tablets administered orally without regard to food Other names: GS-9883 Drug: Lenacapavir Tablets administered orally without regard to food Other names: GS-6207 Drug: B/F/TAF Tablets administered orally without regard to food Other names: Biktarvy ® Drug: Placebo to match BIC/LEN Tablets administered orally without regard to food

Recruiting Locations

More Details

NCT ID: NCT06333808
Status: Active, not recruiting
Sponsor: Gilead Sciences

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.