Study to Evaluate the Safety and Effect of HIVconsv Vaccines in Combination With Histone Deacetylase Inhibitor Romidepsin on the Viral Rebound Kinetic After Treatment Interruption in Early Treated HIV-1 Infected Individuals
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (340 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-10-30, after 2016-02-29 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2017-10-30. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Collaborators: 7 (lowers risk) · Design
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: cancercellsdiseaseulncell
Phrases that lowered it: evaluateeffect ofscreeningvisithiv infected -
Drug's FAERS reports with a death: 32.8% (raises risk) · Drug's FDA history
-
Phase: 1 (lowers risk) · Design
-
Design: single group (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Maximum age: 99 (lowers risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports marked serious: 93.4% (raises risk) · Drug's FDA history
-
Number of arms: 1 (raises risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 7 (typical: 0)
- Keywords listed
- 8 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 99 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 256 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 114 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 32.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, immunology, urogenital
- Drugs matched to FDA substances
- romidepsin
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Safety and Efficacy of Romidepsin and the Therapeutic Vaccine Vacc-4x for Reduction of the Latent HIV-1 Reservoir NCT02092116 · started 2014 · scored riskier than 27% of active trials completed
- LRAs United as a Novel Anti-HIV Strategy. NCT03525730 · started 2018 · scored riskier than 24% of active trials completed
- Reducing the Residual Reservoir of HIV-1 Infected Cells in Patients Receiving Antiretroviral Therapy NCT02471430 · started 2016 · scored riskier than 37% of active trials completed
- Efficacy of VHM After Treatment Interruption in Subjects Initiating ART During Acute HIV Infection NCT02475915 · started 2015 · scored riskier than 12% of active trials completed
- Early Administration of Romidepsin and 3BNC117 in Treatment-naïve HIV Patients Starting ART NCT03041012 · started 2017 · scored riskier than 14% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.