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An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2)

NCT02831764 on ClinicalTrials.gov Phase 3 ViiV Healthcare (industry) Started 2016-07-18 Completed
Riskier than 12% of active trials
this trial: 9% 0% 36%

Model scores of the 29,894 trials active now.

Model score 9% 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 6% of the time (876 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2022-06-29, after 2016-07-18 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

0% 17% 34% 52% 69% 0123456 yr completed 60% terminated 11%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2022-06-29. 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

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
3 (typical: 2)
Number of arms
2
Allocation
randomized
Design
parallel
Primary purpose
treatment
Blinding
double (typical: none)
Has a data monitoring committee
Yes (typical: 56% yes)
Responsible party
sponsor
Collaborators
1 (typical: 0)
Keywords listed
7 (typical: 1)

Who can join

Minimum age
18
Maximum age
not given (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
117 (typical: 32)
Sponsor's past termination rate
8.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
38 (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
58476 (typical: 2148)
Drug's FAERS reports in the prior 12 months
11583 (typical: 412.5)
Drug's FAERS reports marked serious
85.9% (typical: 85.6%)
Drug's FAERS reports with a death
10.4% (typical: 15.9%)

Disease area and drugs

Disease areas
infectious disease, immunology, urogenital
Drugs matched to FDA substances
dolutegravir, emtricitabine, lamivudine, tenofovir, 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

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.