| Methods |
Multicenter study conducted from 15 December 1998 to 27 October 1999 at 47 sites of which 19 were in USA and 28 located worldwide, primarily Europe, Latin America, Canada and South Africa. |
| Participants |
366 patients enrolled and randomised to one of two treatment arms.
Eligibility criteria:
Older than 18 years Confirmed HIV Infection -
Clinical evidence of pseudomembranous oropharyngeal candidiasis
≥2 discrete pseudomembranous plaques; or single confluent plaque of ≥3dm
Microbiological evidence of Candida species documented by either KOH or fungal stain. Anticipated survival of >2 months Ability to swallow study medication Karnofsky performance score ≥ 60
Exclusion criteria:
Systemic fungal therapy during week before enrolment Use of topical antifungal treatment within 2 days of enrolment Received other investigational agents in preceding month. Intolerant to azole drugs Used protease inhibitors for 1st time within 30 days before enrolment Taking medication which could interacts with azoles.
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| Interventions |
Pozaconazole 200mg oral suspension (40mg/ml) on day 1, followed by 100 mg/day for 13 days. (178 participants) Fluconazole 200 mg oral suspension (40mg/ml) on day 1 followed by 100mg/day for 13 days (172 participants) |
| Outcomes |
Primary: Clinical cure = proportion of patients who were clinically cured or showed improvement after 14 days of treatment
Secondary:
Mycological cure = Quantitative yeast culture yielding ≤20cfu/ml of Candida species. Eradication = 0cfu/ml Mycological relapse = ≤20cfu/ml of Candida species on day 14 and >20 cfu/ml on day42 Clinical relapse = recurrence of signs or symptoms after initial improvement on day 14 Safety
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| Notes |
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| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
No indication how sequence was generated |
| Allocation concealment? |
High risk |
Not reported |
| Blinding?
All outcomes |
Low risk |
Evaluators were blinded/masked |
