CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 143 enrolled
Drug / intervention
Amphotericin B +1 moredrug
Likely dose
Amphotericin B 0.7 mg/kg IV daily for 14 days (extendable up to 21 days); Fluconazole 400-800 mg daily (or weight-adjusted 200-400 mg/kg daily for baseline weight <40 kg)AI-extracted
Key inclusion· 5
  • ✓First episode of cryptococcal meningitis confirmed by positive CSF stain, CSF antigen, or pending culture
  • ✓Documented or presumptive HIV-1 infection (confirmed or pending confirmation with lab testing within 10 days of entry)
  • ✓Age 13 years or older
  • ✓Baseline ECG with QTc interval ≤500 milliseconds (Fredericia's Correction)
Key exclusion· 12
  • ✕Pregnancy or breastfeeding
  • ✕Concurrent CNS process interfering with assessment (e.g., lymphoma, toxoplasmosis, tuberculosis)
  • ✕Estimated creatinine clearance <50 mL/min
  • ✕AST or ALT >5× upper limit of normal, or bilirubin >2.5× upper limit of normal

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00145249
NCT00145249Phase 2Completed
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A Phase II Randomized Trial of Amphotericin B Alone or Combined With Fluconazole in the Treatment of AIDS-Associated Cryptococcal Meningitis

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Sep 5, 2005·Updated May 16, 2012

In Brief

A Phase 2 clinical trial evaluating Amphotericin B and Fluconazole for Cryptococcal Meningitis. Completed, enrolled 143 participants across 15 sites in 2 countries.

Detailed Summary

This study will examine the effectiveness and safety of a combination treatment for cryptococcal meningitis, a fungal infection common in persons with acquired immune deficiency syndrome (AIDS) in the developing world. The standard initial treatment includes two medications: amphotericin B for 2 weeks followed by 8 weeks of fluconazole. This study will look at whether study participants recover more quickly and have fewer side effects if they are given both drugs at the same time for 2 weeks followed by 8 weeks of fluconazole as compared to the standard treatment. Participants will be followed for approximately 6 months from the time they are enrolled into the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCryptococcal Meningitis
CountriesThailand, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2005
Enrollment StartMay 1, 2005
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.8 years ago

Interventions

Amphotericin Bdrug

Amphotericin B 0.7 mg/kg IV for the first 14 days of treatment. This period may be extended up to an additional 7 days.

Fluconazoledrug

Fluconazole 400 or 800 mg daily. Among subjects whose baseline weight is less than 40 kg, randomized fluconazole doses will be 200 mg/kg daily or 400 mg/kg daily.