Short course interferon-gamma for human immunodeficiency virus (HIV)-associated cryptococcal meningitis
| ISRCTN | ISRCTN72024361 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72024361 |
| Secondary identifying numbers | CM-IFN.1 |
- 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
Scientific
Centre for Infection
St George's University of London
London
SW17 ORE
United Kingdom
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Interferon gamma |
| Primary outcome measure | 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 study start date | 10/07/2007 |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 (40 per arm, three arms) |
| 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
- South Africa
- United Kingdom
Study participating centre
St George's University of London
London
SW17 ORE
United Kingdom
SW17 ORE
United Kingdom
Sponsor information
St George's University of London (UK)
University/education
University/education
Research Office
Cranmer Terrace
London
SW17 ORE
United Kingdom
| Website | http://www.sgul.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/040f08y74 |
Funders
Funder type
Charity
Wellcome Trust
Private sector organisation / International organizations
Private sector organisation / International organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
