Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)
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 4% of the time (217 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-12-21, after 2018-06-12 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 2022-12-21. 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
-
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Phase: 1 (lowers risk) · Design
-
Sponsor's past termination rate: 11.5% (raises risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Design: single group (raises risk) · Design
-
Drug's FAERS reports with a death: 7.4% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 63.3% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 191484 (lowers risk) · Drug's FDA history
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Number of arms: 1 (raises 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 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- basic science (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 5 (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
- 130 (typical: 32)
- Sponsor's past termination rate
- 11.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 191484 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 27242 (typical: 412.5)
- Drug's FAERS reports marked serious
- 63.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 7.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, immunology, urogenital
- Drugs matched to FDA substances
- isoniazid, pyridoxine, rifapentine, tenofovir alafenamide, vitamin b
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
- Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers NCT02771249 · started 2016 · scored riskier than 11% of active trials completed
- Evaluating the Safety and Drug Interaction of PA-824, an Investigational Tuberculosis Medication, Together With Efavirenz, Ritonavir-Boosted Lopinavir, or Rifampin NCT01571414 · started 2012 · scored riskier than 4% of active trials completed
- PanACEA Sutezolid Dose-finding and Combination Evaluation NCT03959566 · started 2021 · scored riskier than 12% of active trials completed
- Early Bactericidal Activity of TBA-7371 in Pulmonary Tuberculosis NCT04176250 · started 2020 · scored riskier than 16% of active trials completed
- A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy NCT05917509 · started 2023 · 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.