Autopsy report · NCT00080119

Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV

“Data Safety Monitoring Board (DSMB) recommended stopping study due to futility”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month after it had already started.
• Ran for about 5 years 3 months before it stopped.
• 1,354 participants enrolled.
• Results were posted on the registry 1 year 5 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2, Phase 3

Sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Sponsor type

University, hospital or other

Conditions

HIV Infection; Tuberculosis; Pneumocystis Jiroveci Pneumonia

Interventions

Isoniazid (INH); Trimethoprim/Sulfamethoxazole (TMP/SMX); Isoniazid Placebo (PL)

Participants

1,354

Sites

6

Countries

Botswana, South Africa

Trials that died the same way

• A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung
  “The Data Safety Monitoring Board (DSMB) recommended study termination for slow accrual and futility.” (90% match in meaning)
• Methylprednisolone in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS)
  “Following a recommendation from the Data Safety Monitoring Board (DSMB).” (74% match in meaning)
• ATG Plus Low-dose PT-Cy for GVHD Prevention
  “DSMB recommended halting the study owing to futility after the first interim analysis in August 2024.” (73% match in meaning)
• Pilot Study of Varenicline (Chantix®) in the Treatment of Friedreich's Ataxia
  “The DSMB recommended that the study be stopped as a result of concerns regarding safety and intolerability and insufficient evidence of efficacy.” (72% match in meaning)
• Dichloroacetate (DCA) in Patients With Previously Treated Metastatic Breast or Non-Small Cell Lung Cancer (NSCL)
  “DSMB determined, due to higher than expected risk/safety concerns, study should be closed.” (70% 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.