Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06630286 | Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 | PHASE3 | ACTIVE NOT_RECRUITING | 609 | — | — | Oct 9, 2024 | Aug 1, 2030 | Apr 30, 2026 | 106 | United States, Argentina +10 |
| NCT06630299 | Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 | PHASE3 | ACTIVE NOT_RECRUITING | 600 | — | — | Oct 8, 2024 | Aug 1, 2030 | May 29, 2026 | 100 | United States, Argentina +12 |
| Arm | Type | Description |
|---|---|---|
| Blinded Phase: ISL/LEN + Placebo-to-Match (PTM) B/F/TAF | EXPERIMENTAL | 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. |
| Blinded Phase: PTM ISL/LEN + B/F/TAF | EXPERIMENTAL | 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. |
| Open- Label Extension (OLE) Phase | EXPERIMENTAL | 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. |
| ISL/LEN | EXPERIMENTAL | 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. |
| Standard of Care Treatment | ACTIVE_COMPARATOR | Participants will continue standard of care treatment with 2-3 ARVs up to Week 96: * Integrase Strand Transfer Inhibitor (INSTI) class: INSTI combined with 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs; bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®), dolutegravir (DTG)/abacavir (ABC)/lamivudine (3TC), DTG+ TAF or TDF (TXF)/emtricitabine (FTC; Emtriva®), DTG/tenofovir disoproxil fumarate (TDF; Viread®)/3TC, DTG/3TC, raltegravir (RAL) + TXF/FTC, RAL+TDF/3TC, elvitegravir (EVG; Vitekta®)/cobicistat (c; Tybost®)/TXF/FTC), or * PI class: Boosted protease inhibitor (PI) combined with 2 NRTIs (darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF; coformulated), boosted darunavir (DRV)+TXF/FTC, boosted DRV+TDF/3TC), or * NNRTI class: Nonnucleoside reverse transcriptase inhibitor (NNRTI) combined with 2 NRTIs (doravirine (DOR)/TDF/3TC, DOR+TXF/FTC, DOR+TDF/3TC, rilpivirine (RPV)/TXF/FTC, RPV+TXF/FTC, RPV+TDF/3TC) |
| Extension Phase | EXPERIMENTAL | At the end of randomized treatment visit, if safety and efficacy of ISL/LEN are demonstrated following review of randomized data, participants will be given the option to receive ISL/LEN tablets 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 during the randomized phase will continue to take ISL/LEN weekly. Participants receiving standard of care during the randomized phase will take an initial dose of ISL/LEN (Dose A), followed by once weekly ISL/LEN (Dose B) from Day 8 onwards. |
| Name | Type | Description |
|---|---|---|
| ISL/LEN | DRUG | Tablet administered orally |
| B/F/TAF | DRUG | Tablet administered orally |
| PTM B/F/TAF | DRUG | Tablet administered orally |
| PTM ISL/LEN | DRUG | Tablet administered orally |
| Antiretroviral Combinations | DRUG | 2 or 3 antiretrovirals (ARVs) administered as defined by the investigator, according to the prescribing information. |
Key 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 \< ...