Study to Evaluate a HIV Drug for the Treatment of HIV Infection
Model scores of the 29,894 trials active now.
Model score 11% 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 8% of the time (780 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 2014-11-29, after 2013-04-04 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
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2014-11-29. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: bmsqtwomenmsecplacebo
Phrases that lowered it: infecteddrughivgastrointestinalblood -
Sponsor's past termination rate: 13.0% (raises risk) · Sponsor's track record
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Number of arms: 13 (lowers risk) · Design
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Phase: 2 (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 10.5% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 27 (lowers risk) · Sponsor's track record
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Blinding: triple (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Has a data monitoring committee: No (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Sponsor's past trials: 69 (lowers risk) · Sponsor's track record
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Disease area, infectious disease: Yes (lowers risk) · Disease area
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Maximum age: 55 (lowers risk) · Who can join
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports before start: 31690 (lowers risk) · Drug's FDA history
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Keywords listed: 0 (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
- 2
- Number of arms
- 13 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 55 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 69 (typical: 32)
- Sponsor's past termination rate
- 13.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 27 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 31690 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4455 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, immunology, urogenital
- Drugs matched to FDA substances
- atazanavir, emtricitabine, ritonavir, tenofovir
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
- Pharmacodynamics, Safety and Pharmacokinetics of BMS-663068, an HIV Attachment Inhibitor, in HIV-1 NCT01009814 · started 2009 · scored riskier than 13% of active trials completed
- Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection NCT01199731 · started 2010 · scored riskier than 22% of active trials terminated
- Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults NCT02415595 · started 2015 · scored riskier than 21% of active trials terminated
- A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen NCT02105987 · started 2014 · scored riskier than 22% of active trials completed
- Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults NCT00892437 · started 2009 · scored riskier than 48% 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.