Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women

Study Overview
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Brief Summary
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There is an urgent need for HIV prevention methods that women can initiate and control themselves. Topical microbicides, substances that kill microbes, represent one such method. The purpose of this study is to assess the safety and to evaluate the acceptability of 3% w/w SPL7013 gel, a topical microbicide, when administered intravaginally for 14 consecutive days in healthy, sexually active HIV uninfected women.

Detailed Description
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Women continue to comprise a growing proportion of the new HIV infections around the world. A growing body of data suggests that a safe and effective topical microbicide will be a real option of prevention for women in the future. The purpose of this study is to assess the safety and acceptability of 3% SPL7013 Gel when administered intravaginally, twice daily for 14 consecutive days in healthy, sexually-active, HIV-uninfected women. The expected duration of this study for each participant is 21 days. Study participants will be randomly assigned to one of two arms. Participants in Arm 1 will apply 3.5 g of SPL7013 gel intravaginally twice daily for 14 consecutive days. Participants in Arm 2 will apply a placebo gel intravaginally twice daily for 14 consecutive days. Starpharma produces SPL7013 gel (VivaGel) and will provide it for this study. After enrollment, participants will attend three study visits. These visits will occur on Days 7, 14, and 21. A follow-up safety visit will occur if necessary. Medical and menstrual history, targeted physical exam, urine and blood collection, cervical swabs, and vaginal smears will occur at all visits. A colposcopy will occur at least once. On Day 2, participants will take part in a phone assessment.

Official Title
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Phase 1 Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women

Conditions
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Healthy

Intervention / Treatment
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* Drug: 3% SPL7013 Gel (VivaGel)
* Drug: Placebo Gel
* Drug: HEC Placebo Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-uninfected General good health Normal Pap result within 12 months prior to study entry Predictable menstrual cycle with at least 21 days between menses Sexually active Willing to use effective methods of contraception for the duration of the study. More information on this criterion can be found in the protocol. Willing to abstain from oral-vaginal and penile-anal intercourse for the duration of the study Willing to not use other intravaginal products and/or devices for 72 hours prior to study entry through Week 3 Agree to have partner use condoms provided by study for each act of intercourse during study participation Willing to undergo colposcopy if determined necessary by investigator Agree to not participate in other drug or device studies during study participation Exclusion Criteria: History of adverse reaction to latex or to any component of the study products History of male sex partner having an allergic reaction to latex Any abnormal finding on physical or pelvic examination Sexually transmitted infection (STI) or reproductive tract infection. More information on this criterion is available in the protocol. Diagnosed with STI within 6 months prior to study entry Use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to study entry Gynecological surgical procedure within 90 days prior to study entry Certain abnormal laboratory values. More information on this criterion is available in the protocol. Received non-therapeutic intravenous drugs within 12 months prior to study entry Any social or medical condition, that, in the opinion of the investigator, would interfere with the study Pregnant of breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3% SPL7013<br>Intravaginal application of 3.5 g SPL7013 gel twice daily for 14 days | Drug: 3% SPL7013 Gel (VivaGel)<br>* 3% vaginal gel<br>* Other names: VivaGel;|
| Placebo Comparator: Placebo for SPL7013 Gel<br>Intravaginal application of 3.5 g placebo gel twice daily for 14 days | Drug: Placebo Gel<br>* Placebo for SPL7013 gel<br>|
| Placebo Comparator: HEC Placebo Gel<br>Intravaginal application of 3.5 g HEC placebo gel twice daily for 14 days | Drug: HEC Placebo Gel<br>* HEC Placebo gel intravaginally bd for 14 days<br>* Other names: Universal Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of abnormal genital symptoms and/or pelvic exam findings |  | Throughout study | 
| Occurrence of adverse events and/or abnormal laboratory values |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in vaginal microflora |  | Throughout study | 
| Proportion of participants who report an 80% or greater adherence rate |  | At Day 7 and Day 14 | 
| Proportion of participants who say they would be very likely to use the study product in the future |  | At Day 14 | 
| Reported positive and negative aspects of using study product |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety and Acceptability