Condition category
Infections and Infestations
Date applied
20/08/2007
Date assigned
23/08/2007
Last edited
05/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Harrison

ORCID ID

Contact details

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

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

http://www.sgul.ac.uk/

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

Publication citations

Additional files

Editorial Notes