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Trial · NCT01562132

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants Alive at 12 Weeks12 weeks
SecondaryNumber of Participants Alive at 2 Weeks2 weeks
SecondarySurvival at 24 Weeks24 weeks
SecondaryNumber of Individuals Who Develop Cryptococcal Meningitis24 weeks
Clinical meningitis AND at least one of the following: cryptococcal antigen in the cerebrospinal fluid (CSF), cryptococcal organisms on India Ink stain, or fungal culture of CSF. Clinical meningitis will be defined as: * fever\>39.0°C, AND * severe headache, AND At least one of the following: * meningismus, * photophobia, * new onset seizure, * focal neurological deficit localizable to the central nervous system * papilledema * confusion, delirium, or decreased level of consciousness.
SecondaryNumber of Individuals Who Develop Immune Reconstitution Inflammatory Syndrome Due to Cryptococcus24 weeks
Individuals who develop clinical meningitis without evidence of fungal, bacterial, or parasitic (e.g. malaria) organisms in the cerebrospinal fluid. Clinical meningitis will be defined as: * fever\>39.0°C, AND * severe headache, AND * At least one of the following: * meningismus, * photophobia, * new onset seizure, * focal neurological deficit localizable to the central nervous system * papilledema * confusion, delirium, or decreased level of consciousness.
SecondaryAchieve Targeted Recruitment, Retention and Adherence Rates24 weeks
SecondaryProportion of Individuals Requiring Treatment Discontinuation4 weeks
SecondaryProportion of Individuals Requiring Dose Reduction24 weeks
SecondaryNumber of Individuals With Treatment Related Adverse Events24 weeks
SecondaryNumber of Individuals With Treatment Related Serious Adverse Events24 weeks
SecondaryCryptococcal Meningitis-free Survival at 24 Weeks24 weeks
Clinical meningitis AND at least one of the following: cryptococcal antigen in the cerebrospinal fluid (CSF), cryptococcal organisms on India Ink stain, or fungal culture of CSF. Clinical meningitis will be defined as: * fever\>39.0°C, AND * severe headache, AND At least one of the following: * meningismus, * photophobia, * new onset seizure, * focal neurological deficit localizable to the central nervous system * papilledema * confusion, delirium, or decreased level of consciousness.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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