A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 (ISLEND-1)
Kondo Akira
Gilead Sciences K.K.
1-9-2, Marunouchi, Chiyoda-ku, Tokyo
+81-3-6732-7118
ClinicalTrialGSJ@gilead.com
Clinical Operations
Gilead Sciences K.K.
1-9-2, Marunouchi, Chiyoda-ku, Tokyo
+81-3-6837-0740
JPClinicalOperations@gilead.com
Not Recruiting
Dec. 18, 2024
Jan. 27, 2025
600
Interventional
randomized controlled trial
double blind
active control
parallel assignment
treatment purpose
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.
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/uL
5. Hemoglobin < 8.0 g/dL
18age old over
No limit
Both
HIV-1-Infection
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.
Interventions:
- 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.
Interventions:
- Drug: B/F/TAF (Tablet administered orally, 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.
Interventions:
- Drug: ISL/LEN (Tablet administered orally)
Proportion of Participants with HIV-1 RNA >= 50 Copies/mL at Week 48 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm [Time Frame: Week 48]
Proportion of Participants With HIV-1 RNA >= 50 Copies/mL at Week 96 as Determined by the US FDA-Defined Snapshot Algorithm [Time Frame: Week 96]
Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 48 and Weeks 96 as Determined by the US FDA-Defined Snapshot Algorithm [Time Frame: Week 48, Week 96]
Change From Baseline in Cluster of Differentiation 4 (CD4) T-Cell Count at Weeks 48 and Week96 [Time Frame: Week 48, Week96]
Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Day 1 up to Week 48]
Gilead Sciences K.K.
Merck Sharp & Dohme LLC
Applicable
National Hospital Organization Osaka National Hospital Institutional Review Board 1
