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

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ClinicalTrials.gov Identifier: NCT00442910
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : June 24, 2010
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Microbicide Trials Network
Information provided by:
Starpharma Pty Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: 3% SPL7013 Gel (VivaGel) Drug: Placebo Gel Drug: HEC Placebo Gel Phase 1

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 1 Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women
Study Start Date : July 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Active Comparator: 3% SPL7013
Intravaginal application of 3.5 g SPL7013 gel twice daily for 14 days
Drug: 3% SPL7013 Gel (VivaGel)
3% vaginal gel
Other Name: VivaGel
Placebo Comparator: Placebo for SPL7013 Gel
Intravaginal application of 3.5 g placebo gel twice daily for 14 days
Drug: Placebo Gel
Placebo for SPL7013 gel
Placebo Comparator: HEC Placebo Gel
Intravaginal application of 3.5 g HEC placebo gel twice daily for 14 days
Drug: HEC Placebo Gel
HEC Placebo gel intravaginally bd for 14 days
Other Name: Universal Placebo



Primary Outcome Measures :
  1. Incidence of abnormal genital symptoms and/or pelvic exam findings [ Time Frame: Throughout study ]
  2. Occurrence of adverse events and/or abnormal laboratory values [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Changes in vaginal microflora [ Time Frame: Throughout study ]
  2. Proportion of participants who report an 80% or greater adherence rate [ Time Frame: At Day 7 and Day 14 ]
  3. Proportion of participants who say they would be very likely to use the study product in the future [ Time Frame: At Day 14 ]
  4. Reported positive and negative aspects of using study product [ Time Frame: Throughout study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442910


Locations
United States, Florida
University of South Florida
Tampa, Florida, United States, 33606
United States, Pennsylvania
Center for Family Planning Research, Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213-3180
Puerto Rico
University of Puerto Rico
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
Starpharma Pty Ltd
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Microbicide Trials Network
Investigators
Study Chair: Ian McGowan, MD, PhD University of California Geffen School of Medicine