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. 2010 Nov 10;2010(11):CD003940. doi: 10.1002/14651858.CD003940.pub3

Goldman 2005.

Methods Multi‐centre prevention study conducted in the USA: May 1997 through April 2000
Loss to follow‐up: 184 from Episodic Fluconazole
205 from Continuous Fluconazole
Participants Eligibility criteria:
  1. Aged ≥13 years

  2. Confirmed HIV positive and weighed ≥40 kg.

  3. CD4 T cell count of ≤150 cells/mm3 within 30 days of entry

  4. Non pregnant females agrees to practice abstinence and/or birth control

  5. One documented episode of oropharyngeal candidiasis (OPC) in last six months


Exclusion criteria:
  1. Prior fluconazole refractory mucosal infection (FRI), azole allergy or intolerance

  2. ≥ 3 episodes of OPC within 12 weeks before study and/or history of oesophageal candidiasis (OC)

  3. Need for systemic antifungal or >1 month of continuous systemic or oral antifungal within the past 3 months

  4. severe liver disease, serum creatinine level of >3 times the upper limit of normal

  5. Haemoglobin concentration of <8.0g/dL


Subjects who initiated treatment for opportunistic infection 14 days before trial commenced or medication in which coadministration of fluconazole is contraindicated.
829 Patients enrolled:
416 randomised to episodic or intermittent fluconazole
413 randomised to continuous fluconazole
Interventions Fluconazole:
Continuous: 200mg fluconazole orally 3 times weekly
Episodic: Fluconazole only administered for OPC and EC episodes.
Outcomes Primary:
Time to development of fluconazole refractory mucosal Candida infection (FRI)
Secondary:
  1. Incident mucosal infection

  2. Invasive fungal infection

  3. Non‐fungal opportunistic infections

  4. Mortality

Notes Written consent obtained from participants
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Sequence generation not reported
Allocation concealment? Unclear risk Concealment of allocation not reported
Blinding? 
 All outcomes High risk Open‐label study ‐ patients, researchers and evaluators not blinded
Incomplete outcome data addressed? 
 All outcomes High risk 53% loss to follow‐up