Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults
Model scores of the 29,894 trials active now.
Model score 7% 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 6% of the time (122 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-07-13, after 2015-02-28 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 2018-07-13. 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
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Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Primary purpose: prevention (lowers risk) · Design
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Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 5.5% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: coronarysafety tolerabilityventricularevidencenegative
Phrases that lowered it: evaluate thevaccinehealthyparticipantsparticipant -
Sponsor's past trials: 1020 (raises risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 95 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (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
- 1020 (typical: 32)
- Sponsor's past termination rate
- 5.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 95 (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
- cabotegravir
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
- Study to Evaluate the Safety Tolerability and Acceptability of Long Acting Injections of the Human Immunodeficiency Virus (HIV) Integrase Inhibitor, GSK1265744, in HIV Uninfected Men (ECLAIR) NCT02076178 · started 2014 · scored riskier than 7% of active trials completed
- A Healthy Volunteer And Patient Study To Assess The Safety, Tolerability And Pharmacokinetics Of GSK1265744 NCT00659191 · started 2008 · scored riskier than 8% of active trials completed
- Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC NCT01620944 · started 2012 · scored riskier than 15% of active trials terminated
- Safety and Efficacy Study of GSK2838232 in Human Immunodeficiency Virus (HIV)-1 Infected Adults NCT03045861 · started 2017 · scored riskier than 16% of active trials completed
- Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men NCT02720094 · started 2016 · scored riskier than 9% 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.