Conditions: HIV-1 Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 221
Healthy volunteers: no

Brief summary:
The purpose of this study was to see which one of two medicines (topical gentian violet \[GV\] or nystatin oral suspension) was better than the other in treating Oral Candidiasis (OC). This was measured by whether the study participant still had OC or sores in his/her mouth after 14 days of treatment. Also, safety and tolerability of GV and nystatin in the treatment of OC were assessed.

Detailed description:
A5265 was a phase III, open-label (both the researchers and participants know which treatment was being administered) clinical trial to compare the safety and efficacy of topical GV to that of oral nystatin suspension. Male and female HIV-1 positive participants ≥ 18 years of age were randomized (as if by the toss of a coin) with equal probability and stratified by CD4+ T-cell counts and the use of antiretroviral therapy at the time of study entry to receive either topical GV solution (5 mL swish and gargle for 1 minute and spit two times daily) or nystatin oral suspension (5 mL swish for 1 minute and swallow four times daily) for 14 days. Therapy was considered as failed if participants have no clinical improvement (assessed by severity of pseudomembranous candidiasis) during either treatment regimen. Evaluation of signs and symptoms of oral candidiasis was done by an evaluator who was blinded to the treatment assignment. A total of 494 participants was expected to enroll in the study but due to early study closure only 221 enrolled; and participants are expected to be on the study for about 13 weeks.

Arms:
arm 1: Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate \[spit\] 2 times per day \[BID\]) for 14 days arm 2: Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day \[QID\]) for 14 days

Interventions: intervention 1: Gentian Violet intervention 2: Nystatin oral suspension
Intervention descriptions: intervention 1: Participants were administered topical Gentian violet solution, orally, twice daily for 14 days. intervention 2: Participants were administered Nystatin oral suspension 4 times a day for 14 days.

Protocol document: