Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of a Human Monoclonal Antibody (VRC01) in HIV-Infected Adults Undergoing a Brief Treatment Interruption

Model scores of the 29,894 trials active now.

Model score 9% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 4% of the time (217 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2016-10-31. 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.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: or equalgreaterequal tocellscell
  Phrases that lowered it: participantpharmacokineticshiv infectedkgmale
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 1 (lowers risk) · Design
• Sponsor's past termination rate: 5.9% (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 96 (lowers risk) · Sponsor's track record
• Design: single group (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Sponsor's past trials: 1052 (raises risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Responsible party: sponsor (lowers risk) · Design
• Maximum age: not given (raises risk) · Who can join

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.

• Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART) NCT02411539 · started 2015 · scored riskier than 14% of active trials completed
• VRC 601: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC HIVMAB060-00-AB (VRC01), With Broad HIV-1 Neutralizing Activity, Administered Intravenously or Subcutaneously to HIV-Infected... NCT01950325 · started 2013 · scored riskier than 17% of active trials completed
• Phase 1, Open-label, Single Dose Study to Examine Safety, Tolerability, Pharmacokinetics and Virologic Impact of VRC01LS or VRC07-523LS in HIV-infected Viremic Adults NCT02840474 · started 2017 · scored riskier than 15% of active trials completed
• Pharmacokinetics and Safety of SAR441236 NCT03705169 · started 2019 · scored riskier than 15% of active trials terminated
• The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE NCT03635788 · started 2019 · scored riskier than 16% 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.