Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
3BNC117-LS-J · 1 trial · 1 indication
The proportion of participants reporting a Grade ≥3 systemic (i.e., not a local reaction) adverse event (AE) or any AE (regardless of grade) leading to premature study or treatment discontinuation at least possibly related (as judged by the CMC, blinded to active/placebo treatment) to the combination of 3BNC117-LS-J and 10-1074-LS-J. An AE is any unfavorable and unintended sign, symptom, or diagnosis occurring in a study participant during the conduct of the study regardless of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening, 5=death.
The difference in proportion of participants with viral suppression during analytical treatment interruption (ATI) between those receiving 3BNC117-LS-J and 10-1074-LS-J and those receiving placebo. Viral suppression is defined as no confirmed HIV-1 RNA \>200 copies/mL, at or prior to week 24 of ART discontinuation.
| Arm | Type | Description |
|---|---|---|
| Arm A: 30 mg/kg 3BNC117-LS-J + 10 mg/kg 10-1074-LS-J | EXPERIMENTAL | Participants will receive 30 mg/kg 3BNC117-LS-J and 10 mg/kg 10-1074-LS-J, administered as two intravenous (IV) infusions at Step 1 entry (Day 0). Participants will discontinue ART on Day 2. |
| Arm B: Placebo | PLACEBO_COMPARATOR | Participants will receive dose-volume equivalent placebo IV infusions for both 3BNC117-LS-J and 10-1074-LS-J at Step 1 entry (Day 0). Participants will discontinue ART on Day 2. |
| Name | Type | Description |
|---|---|---|
| 3BNC117-LS-J | DRUG | Administered by intravenous (IV) infusion |
| 10-1074-LS-J | DRUG | Administered by intravenous (IV) infusion |
| Placebo for 3BNC117-LS-J | DRUG | Administered by intravenous (IV) infusion |
| Placebo for 10-1074-LS-J | DRUG | Administered by intravenous (IV) infusion |
Inclusion Criteria: Step 1: * Ability and willingness of participant to provide informed consent. * HIV-1 infection, documented by: * Any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry AND * Confirmed by one of the foll...
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