<strong>IPM</strong><strong>014A</strong> 24 February 2009Final Version 5.0 Page 11 of 76STUDYPOPULATION:SAMPLESIZE:REGIMEN:STUDYDURATION:STATISTICALANALYSIS:Healthy, sexually active, HIV-negative women 18-40 years of age whounderstand the study and can provide informed consent.Approximately 320 women (20-50 per research centre) will be enrolled.Potential participants who consent will be invited to screen for the study.All participants who consent to participate in the study, meet specifiedinclusion/exclusion criteria, have normal findings based upon a physicaland pelvic/speculum examination with colposcopy, and have negativepregnancy, HIV and STI tests, will be invited to enrol in the study. Eligiblewomen will be randomly assigned in a 1:1 ratio to one of two study arms:• Study arm 1: Dapivirine Gel 4759, 0.05% 2.5g• Study arm 2: Matching vehicle placebo gel 2.5g containing nodapivirine.Dapivirine Gel 4759 or placebo gel will be applied by participants oncedaily and adherence will be monitored by the collection of used applicatorsby study staff Monday to Friday (DMA) for a period of 6 weeks. OnSaturday, Sunday and Public Holidays participants may not have contactwith study staff, and may then return used applicators on the followingMonday, or in the case of a public holiday, on the following working day.Clinic visits will be conducted at weeks 0 (enrolment), 1, 2, 4, and 6 wheresafety evaluations will be performed. Participants will have a follow-up visitat week 10, 4 weeks post gel discontinuation. At enrolment and at eachstudy visit, all participants will undergo a pelvic/speculum examination withcollection of cervico-vaginal specimens for vaginal flora assessment; preandpost-test HIV counselling; appropriate HIV/STI risk reductioncounselling including condom dispensing; HIV and pregnancy testing; andcollection of locator, menses, and concomitant medications information.Appropriate contraceptive counselling will be done at screening and allstudy visits except week 10. Colposcopy will be performed at week 0(baseline), and weeks 1, 2, and 6. Cervico-vaginal samples for STI testingand safety laboratory testing will be performed at screening and week 6 oras clinically indicated. Adverse events (AEs) will be assessed at all visitsfollowing enrolment. Acceptability and adherence questionnaires will beadministered at baseline (week 0), and at weeks 2, 6 and 10.The maximum allowable time between screening and enrolment perparticipant is 28 days. Following enrolment into the study, each participantwill be followed for a total of 6 weeks during daily gel use, and 4 weekspost gel discontinuation. It is anticipated that full enrolment per researchcentre will be completed in 24 weeks for a total of up to 34 weeks studyduration. If a research centre cannot complete enrolment within 7 monthsof the Site Initiation Visit (SIV), enrolment at the centre may be terminated.The primary analysis will focus on safety assessments, using the intentto-treatpopulation, and comparing the women who are using DapivirineGel 4759 to women who are using a matching vehicle placebo gel.Restricted * Confidential – Limited Access*
<strong>IPM</strong><strong>014A</strong> 24 February 2009Final Version 5.0 Page 12 of 76Exploratory analyses using a per-<strong>protocol</strong> population or subgroups ofparticular interest may also be performed.The secondary analysis will focus on assessment of gel acceptability; thefeasibility of using a DMA method; the changes in vaginal flora andvaginal pH as compared between the 2 study arms; and sexual behaviourand condom use of women using an intravaginal microbicide. Appropriatestatistical analyses will be performed.An interim analysis of the safety assessment data will be conducted afterapproximately 100 participants have completed 6 weeks of gel use.Restricted * Confidential – Limited Access*
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