Autopsy report · NCT00768989

Phase IIB Pilot of Atazanavir + Raltegravir

“Efficacy endpoint met, but overall experimental dosing regimen not considered optimal to support further clinical development in this population.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month before it started.
• Ran for about 1 year 6 months before it stopped.
• 167 participants enrolled.
• Results were posted on the registry 1 year 8 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Bristol-Myers Squibb

Sponsor type

Industry

Conditions

HIV

Interventions

Atazanavir; Raltegravir; Atazanavir; Ritonavir; Tenofovir/Emtricitabine

Participants

167

Sites

16

Countries

Argentina, France, United States

Trials that died the same way

• Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC)
  “The study did not meet efficacy end point and did not enroll patients in the randomized phase.” (69% match in meaning)
• A Pilot Study of Candesartan as a Treatment for Cocaine Dependence
  “Results of interim efficacy analysis showed results were not promising.” (68% match in meaning)
• Study to Assess LX201 for Prevention of Corneal Allograft Rejection or Graft Failure in Subjects Who Have Experienced One or More Rejection Episodes Following Penetrating Keratoplasty
  “The primary efficacy endpoint was not met” (67% match in meaning)
• A Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Participants With Autism Spectrum Disorder (ASD)
  “The 24-week analysis indicated no clinical or statistical benefit for the primary endpoint for the overall study population. No new safety concerns identified.” (64% match in meaning)
• Anecortave Acetate Injection to Treat Steroid-responsive Intraocular Pressure Increase in Cornea Transplant Patients
  “Preliminary data analysis showed insufficient efficacy to justify continuation.” (64% 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.