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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-12-31

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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3% SPL7013

Intravaginal application of 3.5 g SPL7013 gel twice daily for 14 days

Group Type ACTIVE_COMPARATOR

3% SPL7013 Gel (VivaGel)

Intervention Type DRUG

3% vaginal gel

Placebo for SPL7013 Gel

Intravaginal application of 3.5 g placebo gel twice daily for 14 days

Group Type PLACEBO_COMPARATOR

Placebo Gel

Intervention Type DRUG

Placebo for SPL7013 gel

HEC Placebo Gel

Intravaginal application of 3.5 g HEC placebo gel twice daily for 14 days

Group Type PLACEBO_COMPARATOR

HEC Placebo Gel

Intervention Type DRUG

HEC Placebo gel intravaginally bd for 14 days

Interventions

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3% SPL7013 Gel (VivaGel)

3% vaginal gel

Intervention Type DRUG

Placebo Gel

Placebo for SPL7013 gel

Intervention Type DRUG

HEC Placebo Gel

HEC Placebo gel intravaginally bd for 14 days

Intervention Type DRUG

Other Intervention Names

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VivaGel Universal Placebo

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes