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

Phase 3

Completed

• Conditions: HIV-associated cryptococcal meningitis; Infections and Infestations; Cryptococcosis, unspecified

• Registration Number: ISRCTN45035509
• Lead Sponsor: St George's University of London (UK)

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-31
• Study Completion: 2017-06-01
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 680

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.
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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified