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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05911360 | A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF | PHASE3 | COMPLETED | 203 | — | — | Jul 27, 2023 | Feb 9, 2026 | May 14, 2026 | 56 | United States, Austria +10 |
Participants with HIV-1 RNA \>= 50 c/mL were evaluated. Virologic outcome was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the Week 48 Window. The analysis was done using the modified Snapshot algorithm.
| Arm | Type | Description |
|---|---|---|
| Participants Receiving DTG/3TC FDC | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| DTG/3TC | DRUG | DTG/3TC FDC will be administered once daily. |
Inclusion Criteria: * Participants living with HIV-1 with documented plasma HIV-1 RNA \<50 c/mL within 3 months prior to Screening. * Participants must have been on uninterrupted antiretroviral therapy (ART) for ≥1 year (except for brief periods \[less than 30 days\] where all ART was stopped due t...