Trial · NCT02850016

Romidepsin Plus 3BNC117 Phase 2a Study

NCT02850016, Phase 2, Completed, Rockefeller University; results first posted 2022-07-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Romidepsin Plus 3BNC117 Phase 2a Study. Trials, record NCT02850016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02850016

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Romidepsin Plus 3BNC117 Phase 2a Study
NCT number: NCT02850016
Status: Completed
Phases: Phase 2
Enrollment: 48 participants, actual
Lead sponsor: Rockefeller University
Conditions: Human Immunodeficiency Virus (HIV)
Interventions: 3BNC117, Romidepsin
First posted: 2016-07-29
Last updated: 2022-07-14
Results first posted: 2022-07-14

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Days to Viral Rebound During Analytical Treatment Interruption (ATI)	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
Secondary	Number of of Adverse Events (AE), Serious Adverse Events (SAE), and Serious Unexpected Serious Adverse Reactions (SUSAR).	48 weeks	The occurrence of adverse events was assessed during each follow up visit. Adverse events of grades 1 or higher were reported.
Secondary	Change in the Size of the Proviral HIV-1 Reservoir	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).
Secondary	Plasma HIV-1 RNA	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)
Other	HIV-1 Transcriptional Activity as Determined by Unspliced HIV-1 RNA (CA usHIV-1 RNA) in Circulating Total CD4+ T Cells.	baseline and week 24	The median fold-change in cell-associated unspliced HIV-1 RNA concentrations after romidepsin administration across all infusions

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Days to Viral Rebound During Analytical Treatment Interruption (ATI)	Week 24 to Week 36	Of the 11 participants randomized to Group A, 1 chose not to interrupt ART. Of the 9 participants randomized to Group B, 1 stopped ART earlier than planned in the protocol and 1 chose not to interrupt ART.	days	MEDIAN
SECONDARY	Number of of Adverse Events (AE), Serious Adverse Events (SAE), and Serious Unexpected Serious Adverse Reactions (SUSAR).	48 weeks	All participants who received at least a single dose of the investigational products.	events	NUMBER
SECONDARY	Change in the Size of the Proviral HIV-1 Reservoir	baseline and week 24	Participants who completed dosing per protocol and underwent leukapheresis at baseline and following the interventions (week 24).	HIV-1 DNA per million CD4+ T cells	MEDIAN
SECONDARY	Plasma HIV-1 RNA	48 weeks	Participants with detectable plasma HIV-1RNA during the treatment cycles measure by commercial assays.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	HIV-1 Transcriptional Activity as Determined by Unspliced HIV-1 RNA (CA usHIV-1 RNA) in Circulating Total CD4+ T Cells.	baseline and week 24	Participants who completed dosing according to protocol.	CA-us HIV-1 RNA per million CD4 T cells	MEDIAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Days to Viral Rebound During Analytical Treatment Interruption (ATI)	Group A		18	Inter-Quartile Range 14 to 28	days
Days to Viral Rebound During Analytical Treatment Interruption (ATI)	Group B		28	Inter-Quartile Range 21 to 35	days
Number of of Adverse Events (AE), Serious Adverse Events (SAE), and Serious Unexpected Serious Adverse Reactions (SUSAR).	Group A	All Adverse events related to Romidepsin	112		events
Number of of Adverse Events (AE), Serious Adverse Events (SAE), and Serious Unexpected Serious Adverse Reactions (SUSAR).	Group B	All Adverse events related to Romidepsin	66		events
Number of of Adverse Events (AE), Serious Adverse Events (SAE), and Serious Unexpected Serious Adverse Reactions (SUSAR).	Group A	All Adverse events related to 3BNC117	4		events
Number of of Adverse Events (AE), Serious Adverse Events (SAE), and Serious Unexpected Serious Adverse Reactions (SUSAR).	Group B	All Adverse events related to 3BNC117	0		events
Number of of Adverse Events (AE), Serious Adverse Events (SAE), and Serious Unexpected Serious Adverse Reactions (SUSAR).	Group A	Grade 2 or higher Adverse Events Related to Romidepsin	29		events
Number of of Adverse Events (AE), Serious Adverse Events (SAE), and Serious Unexpected Serious Adverse Reactions (SUSAR).	Group B	Grade 2 or higher Adverse Events Related to Romidepsin	5		events
Number of of Adverse Events (AE), Serious Adverse Events (SAE), and Serious Unexpected Serious Adverse Reactions (SUSAR).	Group A	Grade 2 or higher Adverse Events Related to 3BNC117	1		events
Number of of Adverse Events (AE), Serious Adverse Events (SAE), and Serious Unexpected Serious Adverse Reactions (SUSAR).	Group B	Grade 2 or higher Adverse Events Related to 3BNC117	0		events

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Group A	11
Overall Study	STARTED	Group B	9
Overall Study	COMPLETED	Group A	10
Overall Study	COMPLETED	Group B	7
Overall Study	NOT COMPLETED	Group A	1
Overall Study	NOT COMPLETED	Group B	2

Source ClinicalTrials.gov

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Group A	11	11	29
other	Nausea	Gastrointestinal disorders	Group B	9	9	9
other	Headache	General disorders	Group A	4	11	13
other	Headache	General disorders	Group B	3	9	10
other	Fatigue	General disorders	Group A	5	11	12
other	Fatigue	General disorders	Group B	4	9	4
other	Chills	General disorders	Group A	3	11	8
other	Chills	General disorders	Group B	2	9	2
other	Vomiting	Gastrointestinal disorders	Group A	4	11	8
other	Vomiting	Gastrointestinal disorders	Group B	2	9	2

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group A	0	11
Total, all-cause mortality	Group B	0	9
Total, other adverse events	Group A	11	11
Total, other adverse events	Group B	9	9
Total, serious adverse events	Group A	0	11
Total, serious adverse events	Group B	0	9

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32838558	DERIVED	PubMed
35544074	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Group A vs Group B: Plasma HIV-1 RNA	Trial comparisons
Group A vs Group B: deaths from any cause	Trial comparisons
Group A vs Group B: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02850016

GET https://conductscience.org/api/trials/v1/NCT02850016/events?page=2

API reference For AI assistants