ISRCTN45035509
Completed
Phase 3
A phase III, randomised, controlled trial for the treatment of HIV-associated cryptococcal meningitis: oral fluconazole plus flucytosine or one week amphotericin B-based therapy vs two weeks amphotericin B-based therapy
St George's University of London (UK)0 sites680 target enrollmentJuly 31, 2012
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- St George's University of London (UK)
- Enrollment
- 680
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29539274 2019 results in https://pubmed.ncbi.nlm.nih.gov/30863852/ (added 17/06/2020)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 21/10/2013:
- •1\. Consecutive patients age 18 years or over with a first episode of cryptococcal meningitis on basis cerebrospinal fluid (CSF) India ink and/or CSF cryptococcal antigen.
- •2\. Willing to agree to HIV testing
- •3\. Willing to consent to participate in the study.
- •Previous inclusion criteria:
- •1\. Consecutive patients age \> 18 years with a first episode of cryptococcal meningitis on basis cerebrospinal fluid (CSF) India ink and/or CSF cryptococcal antigen
- •2\. Willing to agree to HIV testing
- •3\. Willing to consent to participate in the study
Exclusion Criteria
- •Current exclusion criteria as of 15/12/2014:
- •1\. Pregnancy or lactation
- •2\. Previous serious reaction to study drugs
- •3\. Concomitant medication that is contraindicated with any study drugs
- •4\. Received \>1 dose of Amphotericin B therapy within 2 weeks of screening
- •5\. Received \> 1 cryptococcal treatment dose (up to 1200 mg) of fluconazole or \> 7 days low dose (200 mg) fluconazole within 2 weeks of screening
- •Previous exclusion criteria from 21/10/2013 to 15/12/2014:
- •1\. Pregnancy or lactation.
- •2\. Previous serious reaction to study drugs
- •3\. Concomitant medication that is contraindicated with any study drugs.
Outcomes
Primary Outcomes
Not specified
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