Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ISL · 3 trials · 2 indications
Participants with a ≥0.5 log10 decrease from Day 1 baseline to Day 8 in HIV-1 RNA were identified by the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL FDC or placebo were analyzed in this outcome measure.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Plasma HIV-1 ribonucleic acid (RNA) quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 24.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 48.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Plasma HIV-1 ribonucleic acid (RNA) quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA ≥50 copies/mL will be reported at week 24.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinue study treatment due to an AE will be reported.
| Arm | Type | Description |
|---|---|---|
| ISL + ART | EXPERIMENTAL | HTE participants with HIV-1 infection take ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. |
| DOR + ART | EXPERIMENTAL | HTE participants with HIV-1 infection take DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. |
| DOR/ISL + ART | EXPERIMENTAL | HTE participants with HIV-1 infection take 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. |
| Placebo + ART | PLACEBO_COMPARATOR | HTE participants with HIV-1 infection take placebo QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. |
| Phase 2: ISL + ULO | EXPERIMENTAL | Islatravir (ISL) 2mg and Ulonivirine (ULO) 200mg administered orally once weekly (qw) for 96 weeks |
| Phase 2: BIC/FTC/TAF | ACTIVE_COMPARATOR | Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) 50/200/25 mg, administered orally once daily (qd) for 96 weeks |
| Phase 3: ISL/ULO and Placebo to BIC/FTC/TAF | EXPERIMENTAL | ISL/ULO fixed dose combination (2/200 mg), administered orally qw, and matching placebo to BIC/FTC/TAF administered orally qd for 96 weeks |
| Phase 3: BIC/FTC/TAF and Placebo to ISL/ULO | ACTIVE_COMPARATOR | BIC/FTC/TAF 50/200/25 mg, administered orally qd, and matching placebo to ISL/ULO administered orally qw for 96 weeks |
| ISL + ULO in Group 1 | EXPERIMENTAL | In part 1 of the study, participants will receive ISL 2mg + ULO 200mg orally once a week (QW) for 48 weeks. In part 2 (2nd 48 weeks), participants will continue to receive ISL 2mg + ULO 200mg once a week till week 96. |
| BIC/FTC/TAF in Group 2 | ACTIVE_COMPARATOR | In part 1 of the study, participants will receive BIC 50mg/FTC 200mg/TAF 25mg orally once daily (QD) for 48 weeks. |
| ISL + ULO in Group 2 | EXPERIMENTAL | In part 2 of the study, participants previously on BIC/FTC/TAF (for the 1st 48 weeks, or part 1) will switch to ISL + ULO, to week 96. |
| Name | Type | Description |
|---|---|---|
| ISL | DRUG | ISL 0.75 mg capsule taken by mouth. |
| DOR | DRUG | DOR 100 mg tablet taken by mouth. |
| DOR/ISL | DRUG | 100 mg DOR/0.75 mg ISL FDC taken by mouth. |
| Placebo to ISL | DRUG | Placebo capsule matched to ISL taken by mouth. |
| Placebo to DOR | DRUG | Placebo tablet matched to DOR taken by mouth. |
| ULO | DRUG | ULO 2 x 100 mg oral tablets administered qw for 96 weeks |
| BIC/FTC/TAF | DRUG | BIC/FTC/TAF 50/200/25 mg oral tablet administered qd for 96 weeks |
| Placebo for BIC/FTC/TAF | DRUG | BIC/FTC/TAF-matching placebo oral tablet administered qd for 96 weeks |
| Placebo to ISL/ULO | DRUG | ISL/ULO-matching placebo oral tablets administered qw for 96 weeks |
| ISL/ULO | DRUG | ISL/ULO fixed-dose combination 2 mg/200 mg oral tablet administered qw for 96 weeks |
Inclusion Criteria: * Is HIV-1 positive. * Has been receiving the same baseline ART for ≥3 months prior to signing the Informed Consent Form/Assent Form. * Weighs ≥35 kg. * Has at least triple-class resistance (must include nucleoside reverse transcriptase inhibitor \[NRTI\], non-nucleoside reverse...
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ISL, also known as islatravir, is an investigational small molecule being developed for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) Infection. It is being studied in combination with other antiretroviral agents for both treatment-experienced and treatment-naive adults with HIV-1.
ISL is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating HIV-1 infection.
ISL is in Phase 3 clinical development for HIV-1 Infection. One Phase 3 trial has been completed, and additional Phase 2 studies are ongoing or active but not recruiting. The drug is investigational and has not been approved by regulatory authorities.
ISL is being studied in several clinical trials. NCT04233216 is a completed Phase 3 study of Doravirine/Islatravir in heavily treatment-experienced participants. NCT06891066 is an active Phase 2 trial of ISL with Ulonivirine once weekly in virologically suppressed adults. NCT07266831 is a recruiting Phase 2 study in treatment-naive people with HIV-1.
ISL is a nucleoside reverse transcriptase translocation inhibitor that works by blocking the action of reverse transcriptase, an enzyme HIV-1 needs to replicate. By inhibiting this enzyme, ISL helps reduce the viral load in people infected with HIV-1.
Yes, ISL is the same as islatravir. The drug is referred to by the abbreviation ISL in clinical trial names and is also known by its full name, islatravir. It is being studied in combination with other antiretrovirals for HIV-1 treatment.