Trial · NCT00885703
High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals
NCT00885703, Phase 1, Phase 2, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2018-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals. Trials, record NCT00885703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00885703
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals
- NCT number
- NCT00885703
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 168 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Cryptococcal Meningitis, HIV Infections
- Interventions
- Fluconazole, Amphotericin B
- First posted
- 2009-04-22
- Last updated
- 2021-11-04
- Results first posted
- 2018-03-12
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B | Measured from study entry through Week10 | Analysis in safety population (see study detailed description for details) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Categorized Quantitative Culture Results | At entry, Week 2, and Week 10 | Arms pooled by dose. Analysis in efficacy population (see study detailed description for details). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change in Log10 Quantitative CSF Culture Results | Entry and Week 2 | Arms pooled by dose. Analysis done in efficacy population (see study detailed description for details). Excludes participants who did not have a week 2 observation. | Log10 CFU/mL | MEDIAN |
| PRIMARY | Kaplan Meier (KM) Proportion of Participant Mortality | Measured from study entry through Week 24 | Arms pooled by dose in the safety population (see study detailed description for details). | proportion of participants | NUMBER |
| SECONDARY | Results of the Neurological Examination | Measured at study entry, Week 2, and Week 10 | Arms pooled by dose. Safety population (see study detailed description for details). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Results of Functional Status Evaluation | Measured 6 weeks before enrollment, at study entry, at Week 10, and at Week 24 | Arms pooled by dose. Safety population (see study detailed description for details). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Length of Hospitalization | Measured from study entry through Week 10 | Arms pooled by dose in safety population (see study detailed description for details). Fluconazole 2000mg arm had one participant data missing (was not admitted to hospital at study entry). | Days | MEDIAN |
| SECONDARY | Number of Hospital Admissions | Measured from study entry through Week 24 | Arms pooled by dose in safety population (see study detailed description for details). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Progression of Symptoms | Measured from study entry through Week 24 | Arms pooled by dose. Analysis done in efficacy population (see detailed study description for details). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With CNS IRIS | Measured from study entry through Week 24 | Arms pooled by dose in study population (see study detailed description for details). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group163
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B | Stage 1, Fluconazole 1200mg | 14 | Participants | ||
| Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B | Stage 1, Fluconazole 1600mg | 11 | Participants | ||
| Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B | Stage 1, Fluconazole 2000mg | 11 | Participants | ||
| Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B | Stage 1, Ampho B | 6 | Participants | ||
| Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B | Stage 2, Fluconazole 1600mg | 12 | Participants | ||
| Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B | Stage 2, Fluconazole 2000mg | 13 | Participants | ||
| Number of Participants Who Discontinued Study-provided High Dose Fluconazole or Ampho B | Stage 2, Ampho B | 6 | Participants | ||
| Categorized Quantitative Culture Results | Fluconazole 1200mg | Week 0 / CM Positive | 20 | Participants | |
| Categorized Quantitative Culture Results | Fluconazole 1600mg | Week 0 / CM Positive | 45 | Participants | |
| Categorized Quantitative Culture Results | Fluconazole 2000mg | Week 0 / CM Positive | 43 | Participants |
1 to 10 of 163Source ClinicalTrials.gov
See all 163 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stage 1, Fluconazole 1200mg | 22 | |
| Overall Study | STARTED | Stage 1, Fluconazole 1600mg | 26 | |
| Overall Study | STARTED | Stage 1, Fluconazole 2000mg | 24 | |
| Overall Study | STARTED | Stage 1, Ampho B | 24 | |
| Overall Study | STARTED | Stage 2, Fluconazole 1600mg | 24 | |
| Overall Study | STARTED | Stage 2, Fulconazole 2000mg | 24 | |
| Overall Study | STARTED | Stage 2, Ampho B | 24 | |
| Overall Study | COMPLETED | Stage 1, Fluconazole 1200mg | 12 | |
| Overall Study | COMPLETED | Stage 1, Fluconazole 1600mg | 16 | |
| Overall Study | COMPLETED | Stage 1, Fluconazole 2000mg | 13 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,008
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Stage 1: 1200mg Fluconazole | 3 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1: 1600mg Fluconazole | 2 | 26 | |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1: 2000mg Fluconazole | 0 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1: Ampho B | 3 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Stage 2: 1600mg Fluconazole | 1 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Stage 2: 2000mg Fluconazole | 3 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Stage 2: Ampho B | 5 | 24 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Stage 1: 1200mg Fluconazole | 1 | 22 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Stage 1: 1600mg Fluconazole | 1 | 26 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Stage 1: 2000mg Fluconazole | 2 | 24 |
1 to 10 of 1,008Source ClinicalTrials.gov
See all 1,008 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1: 1200mg Fluconazole | 9 | 22 |
| Total, all-cause mortality | Stage 1: 1600mg Fluconazole | 7 | 26 |
| Total, all-cause mortality | Stage 1: 2000mg Fluconazole | 8 | 24 |
| Total, all-cause mortality | Stage 1: Ampho B | 7 | 24 |
| Total, all-cause mortality | Stage 2: 1600mg Fluconazole | 7 | 24 |
| Total, all-cause mortality | Stage 2: 2000mg Fluconazole | 8 | 24 |
| Total, all-cause mortality | Stage 2: Ampho B | 4 | 24 |
| Total, other adverse events | Stage 1: 1200mg Fluconazole | 22 | 22 |
| Total, other adverse events | Stage 1: 1600mg Fluconazole | 26 | 26 |
| Total, other adverse events | Stage 1: 2000mg Fluconazole | 24 | 24 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00885703
GET https://conductscience.org/api/trials/v1/NCT00885703/results?page=2