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Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), Administered Intravenously or Subcutaneously to Healthy Adults

NCT01993706 on ClinicalTrials.gov Phase 1 National Institute of Allergy and Infectious Diseases (NIAID) (government) Started 2013-11-19 Completed
Riskier than 6% of active trials
this trial: 5% 0% 36%

Model scores of the 29,894 trials active now.

Model score 5% for any early termination, 1% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Completed on 2015-02-27, after 2013-11-19 start.

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Termination over time, as the model saw it at the start

0% 20% 39% 59% 79% 0123456 yr completed 68% terminated 10%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2015-02-27. 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

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
not given (typical: 2)
Allocation
randomized
Design
parallel
Primary purpose
prevention (typical: treatment)
Blinding
not given (typical: none)
Has a data monitoring committee
not given (typical: 56% yes)
Responsible party
sponsor
Collaborators
0
Keywords listed
6 (typical: 1)

Who can join

Minimum age
18
Maximum age
50 (typical: 71)
Sex
all
Accepts healthy volunteers
Yes (typical: 9% yes)

Sponsor's track record

Sponsor type
government (typical: academic or other)
Sponsor's past trials
961 (typical: 32)
Sponsor's past termination rate
5.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
85 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history
0 (typical: 1)
Drug has FAERS history
No (typical: 64% yes)
Drug's FAERS reports before start
0 (typical: 2148)
Drug's FAERS reports in the prior 12 months
0 (typical: 412.5)
Drug's FAERS reports marked serious
no FAERS history (typical: 85.6%)
Drug's FAERS reports with a death
no FAERS history (typical: 15.9%)

Disease area and drugs

Disease areas
infectious disease, immunology, urogenital
Drugs matched to FDA substances
none matched

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

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.