Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
Model scores of the 29,894 trials active now.
Model score 6% 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 13% of the time (1,304 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-11-24, after 2019-09-19 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 2022-11-24. 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
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: cancerinfectioncellpriorhiv
Phrases that lowered it: pharmacokineticsvisitevaluate thetolerabilitysafety -
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Sponsor's past termination rate: 17.2% (raises risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Primary purpose: prevention (lowers risk) · Design
-
Sponsor's past trials: 1260 (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 123 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
-
Blinding: double (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 3 (lowers risk) · Design
-
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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (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
- industry (typical: academic or other)
- Sponsor's past trials
- 1260 (typical: 32)
- Sponsor's past termination rate
- 17.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 123 (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
- none of the 14 tracked areas
- Drugs matched to FDA substances
- islatravir
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
- A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003) NCT02217904 · started 2015 · scored riskier than 35% of active trials completed
- Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007) NCT06045507 · started 2023 · scored riskier than 12% of active trials completed
- MK-8583 Single Dose Study in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants (MK-8583-002) NCT03552536 · started 2018 · scored riskier than 38% of active trials completed
- Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) NCT03272347 · started 2017 · scored riskier than 28% of active trials completed
- Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013] NCT04564547 · started 2021 · scored riskier than 46% 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.