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 个研究点目标入组 680 人开始时间: 2012年7月31日最近更新: 2020年6月29日

试验速览

•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

•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.
•4. Received >1 dose of amphotericin B or fluconazole therapy within 2 weeks of screening
•Original exclusion criteria:
•1. Pregnancy or lactation
•2. Previous serious reaction to study drugs
•3. Concomitant medication that is contraindicated with any study drugs
•4. Already on anti-retroviral therapy (ART)

发起方

St George's University of London (UK)