Condition category
Infections and Infestations
Date applied
18/05/2001
Date assigned
18/05/2001
Last edited
12/10/2011
Prospective/Retrospective
Prospectively 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 David Lalloo

ORCID ID

Contact details

Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
+44 (0)151 708 9393
dlalloo@liverpool.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0100035

Study information

Scientific title

Acronym

CRYPTOPRO-UGANDA

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Not provided at time of registration

Primary outcome measures

The primary endpoints of the trial will be invasive cryptococcal disease and mortality attributable to cryptococcal disease.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2003

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Inclusion: adults (age >15)
2. CD4 count below 200 cells
3. Giving informed consent to the study

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

590

Participant 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

Recruitment start date

01/10/2003

Recruitment end date

31/03/2007

Locations

Countries of recruitment

Uganda

Trial participating centre

Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21982529

Publication citations

  1. Results

    Parkes-Ratanshi R, Wakeham K, Levin J, Namusoke D, Whitworth J, Coutinho A, Mugisha NK, Grosskurth H, Kamali A, Lalloo DG, , Primary prophylaxis of cryptococcal disease with fluconazole in HIV-positive Ugandan adults: a double-blind, randomised, placebo-controlled trial., Lancet Infect Dis, 2011, 11, 12, 933-941, doi: 10.1016/S1473-3099(11)70245-6.

Additional files

Editorial Notes