Trial · NCT00885703
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B | Measured from study entry through Week10 | Discontinuation of study-provided high dose fluconazole at or by week 10 Discontinuation of study-provided ampho B at or by week 2 Discontinuation includes discontinuing for any reason, including progression of symptoms, death, etc. |
| Primary | Categorized Quantitative Culture Results | At entry, Week 2, and Week 10 | Count of participants who were CM negative (had no cryptococcal growth), CM negative after switching treatment (switched from Fluconazole to Ampho B or vice versa and later became CM negative), CM positive, Died, Lost to follow-up. Note: CM positive means continued to have cryptococcal growth. |
| Primary | Change in Log10 Quantitative CSF Culture Results | Entry and Week 2 | Change in quantitative CSF (cerebrospinal fluid) cultures. Note: No further CSF specimens are drawn following a negative culture. Thus, only week 2 CSF cultures are considered in this analysis. |
| Primary | Kaplan Meier (KM) Proportion of Participant Mortality | Measured from study entry through Week 24 | Kaplan Meier Proportion of participants who died over study with 90% Confidence Intervals. |
| Secondary | Results of the Neurological Examination | Measured at study entry, Week 2, and Week 10 | Results from Glasgow Coma Score, which provides assessment of impairment of conscious level in response to defined stimuli. Min score of 0 and max score of 15 (no mental impairment). |
| Secondary | Results of Functional Status Evaluation | Measured 6 weeks before enrollment, at study entry, at Week 10, and at Week 24 | Functional assessment of work status and ability. Consists of 2 measures: 1) Does participants have full time work status 2) Does participant have functional ability to work. The measure from 6 week before enrollment will be referred to as 'baseline'. |
| Secondary | Length of Hospitalization | Measured from study entry through Week 10 | Duration of first hospitalization in days starting at entry in safety population. |
| Secondary | Number of Hospital Admissions | Measured from study entry through Week 24 | Count of number of times a participant was admitted to the hospital. |
| Secondary | Number of Participants With Progression of Symptoms | Measured from study entry through Week 24 | Progression of symptoms is defined as: * Died (including early deaths) * Discontinued Fluconazole and started ampho B * Had a positive cryptococcal culture at week 10 * Microbiological Failure (i.e., relapse of CM) * Complication of CM (e.g., obstructive hydrocephalus or vascular complications such as venous or arterial thrombosis) * CM IRIS causing increased inflammation after ART exposure * New CNS Ol (e.g., toxoplasmosis, PML, CNS lymphoma) * Possibly related to CM but mechanism indeterminate * Other defined complication unrelated to CM |
| Secondary | Number of Participants With CNS IRIS | Measured from study entry through Week 24 | Number of participants who were diagnosed with CNS immune reconstitution inflammatory syndrome (IRIS) |
| Secondary | Number of Participants With Grade 3 and 4 Adverse Events | Measured from study entry through Week 24 | Occurrence of grade 3 (severe) and 4 (life-threatening) sign and symptoms events (as defined by FSTRF Appendix 29) Occurrence of grade 3 (severe) and 4 (life-threatening) laboratory events (as defined by FSTRF Appendix 76) See DAIDS AE Grading table V1.0 |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00885703/registered