Adults 18 to 65, any sex, with Human Immunodeficiency Virus (HIV). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Days to Viral Rebound During Analytical Treatment Interruption (ATI)Primary· Week 24 to Week 36
Viral rebound is defined as HIV-1 RNA ≥ 200 copies/mL on 2 consecutive measurements during ATI. If viral rebound occurs, the date of the first measurement of HIV-1 RNA ≥ 200 copies/mL will be defined as "date of viral rebound
Group
Value
95% CI
Group A
18
14 – 28
Group B
28
21 – 35
Number of of Adverse Events (AE), Serious Adverse Events (SAE), and Serious Unexpected Serious Adverse Reactions (SUSAR).Secondary· 48 weeks
The occurrence of adverse events was assessed during each follow up visit. Adverse events of grades 1 or higher were reported.
All Adverse events related to Romidepsin
Group
Value
95% CI
Group A
112
Group B
66
All Adverse events related to 3BNC117
Group
Value
95% CI
Group A
4
Group B
0
Grade 2 or higher Adverse Events Related to Romidepsin
Group
Value
95% CI
Group A
29
Group B
5
Grade 2 or higher Adverse Events Related to 3BNC117
Group
Value
95% CI
Group A
1
Group B
0
Change in the Size of the Proviral HIV-1 ReservoirSecondary· baseline and week 24
Determined by total HIV-1 DNA and episomal HIV-1 DNA (2-LTR) in circulating total CD4+ T cells at baseline and prior to the ATI period (week 24).
Group
Value
95% CI
Group A
58
27 – 482
Group B
46
0 – 270
Plasma HIV-1 RNASecondary· 48 weeks
As measured by a routine clinical assay (Cobas Taqman; detection limit 20 copies/mL), a transcription mediated amplification (TMA)-based assay (detection limit 12 copies/ml) and/or a single copy assay (detection limit 1-2 copies/mL)
Group
Value
95% CI
Group A
4
Group B
4
HIV-1 Transcriptional Activity as Determined by Unspliced HIV-1 RNA (CA usHIV-1 RNA) in Circulating Total CD4+ T Cells.Secondary· baseline and week 24
The median fold-change in cell-associated unspliced HIV-1 RNA concentrations after romidepsin administration across all infusions
Group
Value
95% CI
Group A
9
1 – 111
Group B
11
5 – 85
Adverse events — posted to ClinicalTrials.gov
Time frame: 48 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rockefeller University
Last refreshed: 14 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02850016.