Autopsy report · NCT03493568

Switch From Dual Regimens Based on Dolutegravir Plus a Reverse Transcriptase Inhibitor to E/C/F/TAF in Virologically Suppressed, HIV-1 Infected Patients (Be-OnE)

“The futility analysis on 24-week results estimated that there was only 2% probability of verifying the study hypothesis of a higher proportion pat. with no residual viremia through 48w in arm E/C/F/TAF”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 year 2 months after it had already started.
• Ran for about 3 years 6 months before it stopped.
• 100 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

IRCCS San Raffaele

Sponsor type

University, hospital or other

Conditions

HIV-1-infection

Interventions

Genvoya 150Mg-150Mg-200Mg-10Mg Tablet; Dolutegravir 50 mg plus one RTI

Participants

100

Sites

2

Countries

Italy

Trials that died the same way

• Tissue Adhesive vs. Sterile Strips After Cesarean Delivery
  “Based on results of an interim analysis, the study was halted for futility” (65% match in meaning)
• Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion
  “Assessment for futility” (62% match in meaning)
• CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1)
  “Study was terminated after the planned interim analysis as the pre-defined futility threshold was met” (61% match in meaning)
• Efficacy and Safety Study of DP-b99 in Treating Acute Ischemic Stroke
  “The result of a pre-planned interim futility analysis” (60% match in meaning)
• A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
  “The study was stopped for futility based on efficacy results at the interim analysis; no unexpected safety findings were observed.” (59% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.