Short course interferon-gamma for human immunodeficiency virus (HIV)-associated cryptococcal meningitis

ISRCTN	ISRCTN72024361
DOI	https://doi.org/10.1186/ISRCTN72024361
Protocol serial number	CM-IFN.1
Sponsor	St George's University of London (UK)
Funder	Wellcome Trust

Submission date: 20/08/2007
Registration date: 23/08/2007
Last edited: 05/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Thomas Harrison
Scientific

Centre for Infection
St George's University of London
London
SW17 ORE
United Kingdom

Study information

Primary study design	Interventional
Study design	Single-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	Short course adjunctive interferon gamma will increase rate of sterilisation of cerebrospinal fluid (CSF) in human immunodeficiency virus (HIV)-associated cryptococcal meningitis.
Ethics approval(s)	1. UK: London Surrey Borders Research Ethics Committee (REC), 23/05/2007 2. South Africa: University Cape Town REC, 25/06/2007
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Interferon gamma
Primary outcome measure(s)	Early Fungicidal Activity (EFA, the rate of sterilisation of CSF), for each treatment arm.
Key secondary outcome measure(s)	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
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key 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.
Key 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)
Date of first enrolment	10/07/2007
Date of final enrolment	10/07/2009

Locations

Countries of recruitment

United Kingdom
South Africa

Study participating centre

St George's University of London

London
SW17 ORE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes