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 |
| Protocol serial number | G0100035 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- 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
Scientific
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
United Kingdom
| Phone | +44 (0)151 708 9393 |
|---|---|
| dlalloo@liverpool.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Fluconazole |
| Primary outcome measure(s) |
Invasive cryptococcal disease and mortality attributable to cryptococcal disease |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
- Uganda
Study participating centre
Liverpool School of Tropical Medicine
Liverpool
L3 5QA
United Kingdom
L3 5QA
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? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2011 | Yes | No | |
| Results article | results | 13/07/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
17/07/2017: Publication reference added.
