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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03696160 | The Late Presenter Treatment Optimisation Study | PHASE3 | COMPLETED | 447 | — | — | Mar 5, 2019 | Jun 17, 2024 | Dec 17, 2025 | 53 | Belgium, France +5 |
Composite outcome: treatment failure due to either virological or clinical reasons. Virological reasons can either be insufficient virological response or viral rebound. Clinical reasons can be death related to HIV/AIDS/opportunistic infection or severe bacterial infection, new or recurrent AIDS defining event, any serious non-AIDS defining event or clinically relevant adverse events of any grade or immune reconstitution inflammatory syndrome requiring treatment
| Arm | Type | Description |
|---|---|---|
| Biktarvy | EXPERIMENTAL | Bictegravir is an inhibitor of HIV-1 integrase that is being evaluated for the treatment of HIV-1 infection. Biktarvy® received marketing authorisation valid throughout the European Union (EU) in June 2018. Biktarvy is a combination of bictegravir, emtricitabine, and tenofovir (B/F/TAF). Method of administration: One combined B 50mg/F 200mg/TAF 25mg tablet taken orally once daily for up to 48 weeks without regard to food. |
| Symtuza | EXPERIMENTAL | Symtuza® is a boosted PI indicated for the treatment of HIV-1 infection. Symtuza® received marketing authorisation valid throughout the EU in September 2017. Symtuza is a combination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide (D/C/F/TAF) Method of administration: One combined D 800mg/C 150mg/F 200mg/TAF 10mg tablet taken orally once daily for up to 48 weeks with the addition of food. |
| Name | Type | Description |
|---|---|---|
| Biktarvy | DRUG | Integrase inhibitor used to treat HIV-1 infection |
| Symtuza | DRUG | Protease inhibitor used to treat HIV-1 infection |
Inclusion Criteria: 1. The ability to understand and sign a written informed consent form (ICF) and must be willing to comply with all study requirements. 2. Male or non-pregnant, non-lactating females†. 3. Age ≥ 18 years. 4. Have documented, untreated HIV-1 infection with either: 1. AIDS with ...