AMBITION-cm: AMBIsome Therapy Induction OptimizatioN - Intermittent high dose AmBisome® on a high dose fluconazole backbone for cryptococcal meningitis induction therapy in sub-Saharan Africa
Phase 2
Completed
- Conditions
- HIV-associated cryptococcal meningitisInfections and InfestationsHuman immunodeficiency virus [HIV] disease resulting in other conditions
- Registration Number
- ISRCTN10248064
- Lead Sponsor
- St George's University of London (UK)
- Brief Summary
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26081985 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/29945252 (added 10/03/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1. Consecutive patients (male and female) aged > 18 years with a first episode of cryptococcal meningitis (CSF India ink or CrAg test)
2. Known to be HIV positive or willing to undertake an HIV test
3. Willing to agree to participate in the study
Exclusion Criteria
1. Pregnancy or lactation
2. Previous serious reaction to study drugs
3. Already taking antifungals for >48 hours
4. Concomitant medication that is contraindicated with study drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method