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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04233216 | Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019) | PHASE3 | COMPLETED | 35 | — | — | Mar 18, 2020 | Nov 1, 2023 | Dec 27, 2024 | 98 | United States, Australia +16 |
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.
| 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. |
| 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. |
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...