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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN76481529

Enrollment

590

Registered

2001-05-18

Start date

2003-10-01

Completion date

Unknown

Last updated

2017-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Acquired Immunodeficiency Syndrome (AIDS) Infections and Infestations HIV, Acquired Immunodeficiency Syndrome (AIDS)

Interventions

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 p

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Invasive cryptococcal disease and mortality attributable to cryptococcal disease	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

Uganda

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026