Raltegravir Therapy for Women With HIV and Fat Accumulation
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 3% 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 (331 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 2011-12-31, after 2008-09-30 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 2011-12-31. 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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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: therapygrowthstagepriorcells
Phrases that lowered it: antiretroviralraltegravircopies mlhiv rnaart -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 4.4% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 46 (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Collaborators: 5 (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, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 5.1% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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Responsible party: principal investigator (lowers risk) · Design
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Sponsor's past trials: 45 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Minimum age: 18 (raises risk) · Who can join
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Blinding: none (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 72.0% (lowers 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
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 5 (typical: 0)
- Keywords listed
- 12 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 45 (typical: 32)
- Sponsor's past termination rate
- 4.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 46 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 314 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 305 (typical: 412.5)
- Drug's FAERS reports marked serious
- 72.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, metabolic, immunology, dermatology, urogenital
- Drugs matched to FDA substances
- raltegravir
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
- Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy NCT00887653 · started 2009 · scored riskier than 17% of active trials completed
- Switching From PI to RALtegravir in HIV Stable Patients NCT00528892 · started 2008 · scored riskier than 21% of active trials completed
- Raltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery NCT00562510 · started 2008 · scored riskier than 11% of active trials terminated
- Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen NCT03333083 · started 2018 · scored riskier than 20% of active trials terminated
- Comparison of Concentration-time Course of Plasma and Intracellular Raltegravir in Healthy Volunteers NCT01027182 · started 2009 · scored riskier than 4% 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.