Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CM-IFN.1
Study information
Scientific title
Randomised controlled trial of short course adjunctive interferon gamma for inital treatment of human immunodeficiency virus (HIV)-associated cryptococcal meningitis: effect on rate of clearance of infection and immune response
Acronym
Study hypothesis
Short course adjunctive interferon gamma will increase rate of sterilisation of cerebrospinal fluid (CSF) in human immunodeficiency virus (HIV)-associated cryptococcal meningitis.
Ethics approval
1. UK: London Surrey Borders Research Ethics Committee (REC), 23/05/2007
2. South Africa: University Cape Town REC, 25/06/2007
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cryptococcal meningitis
Intervention
Group 1: Amphotericin B 1 mg/kg/d plus flucytosine 25 mg/kg four times a day (qds) for two weeks.
Group 2: Amphotericin B 1 mg/kg/d plus flucytosine 25 mg/kg qds for two weeks plus interferon (IFN)-gamma, 100 micrograms subcutaneous (s/c) three times a week for two weeks (six doses).
Group 3: Amphotericin B 1 mg/kg/d plus flucytosine 25 mg/kg qds for two weeks plus IFN-gamma, 100 micrograms s/c three times a week on days 1 and 3 (two doses).
In all steps, after two weeks, all patients will receive fluconazole 400 mg/d for eight weeks, followed by fluconazole 200mg/d thereafter.
Intervention type
Drug
Phase
Not Applicable
Drug names
Interferon gamma
Primary outcome measures
Early Fungicidal Activity (EFA, the rate of sterilisation of CSF), for each treatment arm.
Secondary outcome measures
1. The proportions of patients in each arm suffering clinical and laboratory-defined side effects
2. Mortality at 2 and 10 weeks by treatment group
Overall trial start date
10/07/2007
Overall trial end date
30/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Patients greater than 18 years (either sex) with a first episode of cryptococcal meningitis on basis of CSF India ink or CSF cryptococcal antigen.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120 (40 per arm, three arms)
Participant exclusion criteria
1. Alanine Aminotransferase (ALT) greater than five times upper limit of normal
2. Polymorphonuclear leukocytes (PMNs) less than 500 x 10^6/L
3. Platelets (Plts) less than 50,000 x 10^6/L
4. Pregnancy or lactation
5. Previous serious reaction to study drugs
6. Concomitant medication that is contraindicated with any study drugs
7. Already on Anti-Retroviral Therapy (ART)
Recruitment start date
10/07/2007
Recruitment end date
10/07/2009
Locations
Countries of recruitment
South Africa
Trial participating centre
St George's University of London
London
SW17 ORE
United Kingdom
Sponsor information
Organisation
St George's University of London (UK)
Sponsor details
Research Office
Cranmer Terrace
London
SW17 ORE
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary