The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE

NCT03635788 on ClinicalTrials.gov Phase 3 National Institute of Allergy and Infectious Diseases (NIAID) (government) Started 2019-03-28 Completed

Riskier than 16% 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 14% of the time (59 trials).

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

How it ended

Completed on 2026-08-17, after 2019-03-28 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

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2026-08-17. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: study entrydefinedpriorregistrationtherapy
Phrases that lowered it: participantparticipantshiv rnacopies mlart
Phase: 3 (lowers risk) · Design
Drug's FAERS reports marked serious: 59.1% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 111 (lowers risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Sponsor's past termination rate: 7.0% (lowers risk) · Sponsor's track record
Sponsor's past trials: 1229 (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 2.9% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Sponsor type: government (raises risk) · Sponsor's track record
Number of arms: 3 (lowers risk) · Design
Collaborators: 1 (raises 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: 3 (typical: 2)
Number of arms: 3 (typical: 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: 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: 1229 (typical: 32)
Sponsor's past termination rate: 7.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 111 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 2418 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 791 (typical: 412.5)
Drug's FAERS reports marked serious: 59.1% (typical: 85.6%)
Drug's FAERS reports with a death: 2.9% (typical: 15.9%)

Disease area and drugs

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

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

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
A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed NCT04542070 · started 2020 · scored riskier than 20% of active trials completed
Evaluating the Safety, Pharmacokinetics, and Antiviral Activity of a Human Monoclonal Antibody (VRC01) in HIV-Infected Adults Undergoing a Brief Treatment Interruption NCT02463227 · started 2015 · scored riskier than 14% of active trials completed
Study to Identify and Determine Best Implementation Practices for Injectable Cabotegravir+Rilpivirine in the United States (US) NCT04001803 · started 2019 · scored riskier than 24% of active trials completed
Pausing Antiretroviral Treatment Under Structured Evaluation NCT06031272 · started 2024 · scored riskier than 20% 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.