Phase 2
Completed N=20
Romidepsin Plus 3BNC117 Phase 2a Study
Source: ClinicalTrials.gov NCT02850016 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Days to Viral Rebound During Analytical Treatment Interruption (ATI) — 18; 28 days
Summary
The aim of this protocol is to evaluate the effects of romidepsin plus 3BNC117 or romidepsin alone on delaying or preventing viral rebound in ART-treated HIV-1-infected individuals during an analytical interruption of ART.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days to Viral Rebound During Analytical Treatment Interruption (ATI) |
18; 28 | — |
| SECONDARY Number of of Adverse Events (AE), Serious Adverse Events (SAE), and Serious Unexpected Serious Adverse Reactions (SUSAR). |
112; 66; 4; 0; 29; 5 | — |
| SECONDARY Change in the Size of the Proviral HIV-1 Reservoir |
58; 46 | — |
| SECONDARY Plasma HIV-1 RNA |
4; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Adults age 18-65 years with documented HIV-1 infection
- CD4+ T-cell count >500 cells/mm3 at screening
- On ART for a minimum of 24 months and HIV-1 RNA plasma level of 50 but 450 msec when calculated using the Fridericia formula from either lead V3 or V4, pathological Q-waves (Q-wave > 40 msec or depth > 0.4-0.5 mV), evidence of a ventricular pre-excitation syndromes, complete or incomplete LBBB or RBBB, second or third degree heart block, QRS duration > 120 msec, or bradycardia defined by sinus rate 1.0 ULN
- Creatinine > 1.0 ULN
- Any vaccination within 14 days prior to 3BNC117 administration
- Receipt of any therapeutic HIV vaccine in the past
- Receipt of any monoclonal antibody or HDAC inhibitor of any kind in the past.
- Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.
Data sourced from ClinicalTrials.gov (NCT02850016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.