Evaluating the Pharmacokinetics, Safety, and Tolerability of Doravirine (MK-1439) and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (MK-1439A) in HIV-1-Infected Children and Adolescents
Model scores of the 29,894 trials active now.
Model score 13% 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 0% of the time (33 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-05-25, after 2018-07-02 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 2022-05-25. 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: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Sponsor's past termination rate: 6.6% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 105 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 8.3% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 1180 (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: enrollmententryprotocolpriorcell
Phrases that lowered it: participantpharmacokineticshiv rnaartmk -
Primary purpose: treatment (raises risk) · Design
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Maximum age: 17 (raises risk) · Who can join
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers 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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- 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
- 12 (typical: 18)
- Maximum age
- 17 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 1180 (typical: 32)
- Sponsor's past termination rate
- 6.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 105 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 12 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, immunology, urogenital
- Drugs matched to FDA substances
- doravirine, doravirine lamivudine tenofovir disoproxil
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
- Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA) NCT04021290 · started 2019 · scored riskier than 14% of active trials completed
- Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents NCT03682848 · started 2019 · scored riskier than 10% of active trials completed
- Study of GS-3242 in Participants With HIV-1; Substudy-05 NCT07001319 · started 2025 · scored riskier than 15% of active trials completed
- Study of GS-1219 in Participants With HIV-1 NCT07115368 · started 2025 · scored riskier than 16% 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.