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Purpose

The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels < 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening. The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by: 1. One HIV-1 RNA < 50 copies/mL immediately preceding the 24 week period prior to screening. 2. Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be < 50 copies/mL. 3. During the 6 to 12 months period prior to screening, transient detectable viremia ≥ 50 copies/mL is acceptable ("blip"), as long as it is not confirmed on 2 consecutive visits. - Plasma HIV-1 RNA levels < 50 copies/mL at screening. - Individuals are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue until Day 1. - Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.

Exclusion Criteria

  • Prior virologic failure. - Prior use of, or exposure to ISL or LEN. - Active, serious infections requiring parenteral therapy within 30 days before randomization. - Active tuberculosis infection. - Acute hepatitis within 30 days before randomization. - Hepatitis B virus (HBV) infection as determined below at the screening visit: 1. Positive HBV surface antigen OR 2. Positive HBV core antibody and negative HBV surface antibody. Note: individuals found to be susceptible to HBV infection (eg negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive HBV vaccination. - Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled. - Any of the following laboratory values at screening: 1. Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula 2. Alanine aminotransferase > 5 x upper limit of normal (ULN) 3. Direct bilirubin > 1.5 x ULN 4. Platelets < 50,000/μL 5. Hemoglobin < 8.0 g/dL Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Blinded Phase: ISL/LEN + Placebo-to-Match (PTM) B/F/TAF 		Participants will receive an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards up to Week 96. Participants will also receive PTM B/F/TAF once daily from Day 1 up to Week 96.
  • Drug: ISL/LEN
    Tablet administered orally
  • Drug: PTM B/F/TAF
    Tablet administered orally
Experimental
Blinded Phase: PTM ISL/LEN + B/F/TAF 		Participants will receive an initial dose of PTM ISL/LEN (Dose A), followed by once weekly PTM ISL/LEN (Dose B) from Day 8 onwards up to Week 96. Participants will also receive B/F/TAF (50/200/25 mg) once daily up from Day 1 up to Week 96.
  • Drug: B/F/TAF
    Tablet administered orally
    Other names:
    • Biktarvy®
  • Drug: PTM ISL/LEN
    Tablet administered orally
Experimental
Open- Label Extension (OLE) Phase 		After the end of Blinded Phase at Week 96, if safety and efficacy of ISL/LEN are demonstrated following review of unblinded data, all participants will be given an option to enter the open-label extension phase to receive ISL/LEN in an extension phase until ISL/LEN becomes available or until the sponsor elects to discontinue the study, whichever occurs first. Participants receiving ISL/LEN and PTM B/F/TAF during the blinded phase will continue to take ISL/LEN weekly. Participants receiving B/F/TAF and PTM ISL/LEN during the blinded phase will take an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards.
  • Drug: ISL/LEN
    Tablet administered orally

Recruiting Locations

Howard Brown Health
Chicago, Illinois 60613

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

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.