Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
3BNC117-LS · 1 trial · 1 indication
Occurrence of Grade ≥2 AE or SAE that are possibly, probably, or definitely related to the study bNAbs during Step 1 (as judged by the CMC, blinded to active/placebo treatment).
Sustained HIV-1 RNA ≥1000 copies/mL over a 4-week period means at least two measurements of HIV-1 RNA ≥1000 copies/mL over 4 weeks with no HIV-1 RNA \<1000 copies/mL measured between them. Through Step 2 means the 4-week period has started between Step 2 week 0 and week 24.Time to sustained HIV-1 RNA ≥1000 copies/mL over 4 weeks is the time to the first measurement that reaches that level over 4 weeks.
| Arm | Type | Description |
|---|---|---|
| Broadly neutralizing antibodies (bNAbs) infusions with antiretroviral therapy (ART) | ACTIVE_COMPARATOR | - |
| Placebo infusions with ART | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 3BNC117-LS | DRUG | 30 mg/kg to be administered via IV at Step 1 (Day 1) |
| 10-1074-LS | DRUG | 10 mg/kg to be administered intravenously at Step 1 (Day 1) |
| Placebo for 3BNC117-LS | DRUG | 0.9% Sodium Chloride Injection to be administered intravenously at Step 1 (Day 1) |
| Placebo for 10-1074-LS | DRUG | 0.9% Sodium Chloride Injection) to be administered IV at Step 1 (Day 1) |
Step 1 Inclusion Criteria: * Confirmed HIV-1, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study Step 1 entry AND Confirmed by one of the following: * A second antibody test from different manufacturers or based on...
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