Autopsy report · NCT02355184

An Extension of Protocol PRO 140_CD01 Study

“FDA required the sponsor to halt enrollment in the trial and transition participants to available therapies for the treatment of their disease. The trial was subsequently terminated once participants were transitioned.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months after it had already started.
• Ran for about 7 years 8 months before it stopped.
• 20 participants enrolled.
• Results were posted on the registry 3 years 3 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

CytoDyn, Inc.

Sponsor type

Industry

Conditions

HIV; Human Immunodeficiency Virus

Interventions

PRO 140 350mg weekly subcutaneous (SC) injection.

Participants

20

Sites

1

Countries

United States

Trials that died the same way

• Safety and Efficacy of MAGE-A3/A6 T Cell Receptor Engineered T Cells (KITE-718) in HLA-DPB1*04:01 Positive Adults With Advanced Cancers
  “The study was terminated due to the sponsor's decision to discontinue the clinical trial.” (81% match in meaning)
• Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia
  “Termination of the clinical trial by sponsor.” (77% match in meaning)
• TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations
  “The Sponsor had decided to terminate this clinical trial due to an insufficient rate of accrual of patients.” (77% match in meaning)
• Pre-emptive Anakinra for Cytokine Event Reduction
  “The trial has been stopped pending FDA approval of modifications to the trial protocol.” (75% match in meaning)
• Acute Effects Of Donepezil On Brain Perfusion And Memory In Subjects With Cognitive Impairment And Mild Alzheimer's Disease
  “The study was terminated because of slow enrollment. The decision to terminate the trial was not based on any safety or efficacy concerns.” (75% 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.