Safety and Pharmacokinetic Study of Fixed Dose Combination of Zidovudine, Lamivudine, and Nevirapine in HIV-Infected Children in Thailand
Model scores of the 29,894 trials active now.
Model score 9% 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 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 2010-01-31, after 2008-10-31 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 2010-01-31. 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
-
Sponsor's past termination rate: 3.5% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Design: crossover (lowers risk) · Design
-
Phase: 1/2 (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 104 (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Minimum age: 0.42 (lowers risk) · Who can join
-
Sponsor's past trials: 711 (raises risk) · Sponsor's track record
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: childrengreater thanthe protocolhepatitisacute
Phrases that lowered it: hiv infectedinformationin hivcombinationcriterion can -
Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 14.1% (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Maximum age: 12 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 95.0% (raises risk) · Drug's FDA history
-
Collaborators: 2 (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
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 0.42 (typical: 18)
- Maximum age
- 12 (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
- 711 (typical: 32)
- Sponsor's past termination rate
- 3.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 104 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 13139 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2700 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, immunology, urogenital
- Drugs matched to FDA substances
- lamivudine, nevirapine, zidovudine
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
- Atazavanir/Ritonavir-based HAART in Children NCT01656109 · started 2011 · scored riskier than 8% of active trials completed
- UNIVERSAL 1: Pharmacokinetic Study of a Novel DTG/FTC/TAF Dose Ratio for Children NCT05993767 · started 2024 · scored riskier than 28% of active trials completed
- Abacavir and Lamivudine PK in Children NCT01656122 · started 2012 · scored riskier than 8% of active trials completed
- Lopinavir (LPV) Dose Reduction NCT01159275 · started 2009 · scored riskier than 7% of active trials completed
- Pediatric Study for Appropriate Dose of Ritonavir Boosted Lopinavir in Thai HIV-infected Children (PEARL) NCT01307124 · started 2011 · scored riskier than 5% 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.