Primary prevention of invasive cryptococcal disease using fluconazole prophylaxis in Human Immunodeficiency Virus (HIV) infected Ugandans

ISRCTN	ISRCTN76481529
DOI	https://doi.org/10.1186/ISRCTN76481529
Secondary identifying numbers	G0100035

Submission date: 18/05/2001
Registration date: 18/05/2001
Last edited: 17/07/2017

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David Lalloo
Scientific

Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom

Phone	+44 (0)151 708 9393
Email	dlalloo@liverpool.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Primary prevention of invasive cryptococcal disease using fluconazole prophylaxis in Human Immunodeficiency Virus (HIV) infected Ugandans
Study acronym	CRYPTOPRO-UGANDA
Study objectives	Designed to determine whether routine use of fluconazole primary prophylaxis in HIV-infected African patients with relatively advanced HIV disease reduces the incidence of and mortality from invasive cryptococcal disease.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	HIV, Acquired Immunodeficiency Syndrome (AIDS)
Intervention	The trial will take place in TASO Masaka in collaboration with the MRC Programme on AIDS in Uganda and will last for 3.5 years in total. A cohort of 590 non-pregnant adults will be randomised 1:1 to placebo or fluconazole over 18 months. Fluconazole 200 mg three times a week will be compared to placebo.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Fluconazole
Primary outcome measure	Invasive cryptococcal disease and mortality attributable to cryptococcal disease
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/10/2003
Completion date	31/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	590
Key inclusion criteria	1. Adults (age >15) 2. CD4 count below 200 cells 3. Giving informed consent to the study
Key exclusion criteria	1. Pregnancy 2. Previous cryptococcal disease 3. Symptoms/signs suggestive of cryptococcal disease or a positive serum cryptococcal antigen test 4. Moribund or bedbound patients who are terminally ill 5. Current antiretroviral therapy
Date of first enrolment	01/10/2003
Date of final enrolment	31/03/2007

Locations

Countries of recruitment

England
Uganda
United Kingdom

Study participating centre

Liverpool School of Tropical Medicine

Liverpool
L3 5QA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2011		Yes	No
Results article	results	13/07/2017		Yes	No

Editorial Notes

17/07/2017: Publication reference added.