A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.

NCT04840199 on ClinicalTrials.gov Phase 2 National Institute of Allergy and Infectious Diseases (NIAID) (government) Started 2022-04-19 Terminated

Riskier than 17% of active trials

Model scores of the 29,894 trials active now.

Model score 10% 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 6% of the time (122 trials).

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

How it ended

Terminated on 2023-11-30, after 2022-04-19 start.

Reason given by the sponsor: “efficacy”

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 2023-11-30. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: heartstudy entrytherapyactiveprior
Phrases that lowered it: copies mlarthiv rnascreeningevaluate the
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Sponsor's past trials: 1386 (raises risk) · Sponsor's track record
Minimum age: 40 (lowers risk) · Who can join
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 19.4% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 78 (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Design: parallel (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Collaborators: 1 (raises risk) · Design
Sponsor's past termination rate: 8.0% (raises risk) · Sponsor's track record
Responsible party: sponsor (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: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 40 (typical: 18)
Maximum age: not given (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: 1386 (typical: 32)
Sponsor's past termination rate: 8.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 78 (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: 1095 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 380 (typical: 412.5)
Drug's FAERS reports marked serious: 82.1% (typical: 85.6%)
Drug's FAERS reports with a death: 19.4% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, immunology, urogenital
Drugs matched to FDA substances: letermovir

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

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Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO) NCT03446573 · started 2018 · scored riskier than 11% of active trials completed
Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults NCT03844386 · started 2019 · scored riskier than 14% of active trials completed
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

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.