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

This study has been completed.
Sponsor:
Collaborators:
Microbicide Trials Network
Information provided by:
Starpharma Pty Ltd
ClinicalTrials.gov Identifier:
NCT00442910
First received: March 2, 2007
Last updated: June 22, 2010
Last verified: June 2010

March 2, 2007
June 22, 2010
July 2007
December 2009   (final data collection date for primary outcome measure)
  • Incidence of abnormal genital symptoms and/or pelvic exam findings [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Occurrence of adverse events and/or abnormal laboratory values [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00442910 on ClinicalTrials.gov Archive Site
  • Changes in vaginal microflora [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Proportion of participants who report an 80% or greater adherence rate [ Time Frame: At Day 7 and Day 14 ] [ Designated as safety issue: No ]
  • Proportion of participants who say they would be very likely to use the study product in the future [ Time Frame: At Day 14 ] [ Designated as safety issue: No ]
  • Reported positive and negative aspects of using study product [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women
Phase 1 Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Healthy
  • Drug: 3% SPL7013 Gel (VivaGel)
    3% vaginal gel
    Other Name: VivaGel
  • Drug: Placebo Gel
    Placebo for SPL7013 gel
  • Drug: HEC Placebo Gel
    HEC Placebo gel intravaginally bd for 14 days
    Other Name: Universal Placebo
  • Active Comparator: 3% SPL7013
    Intravaginal application of 3.5 g SPL7013 gel twice daily for 14 days
    Intervention: Drug: 3% SPL7013 Gel (VivaGel)
  • Placebo Comparator: Placebo for SPL7013 Gel
    Intravaginal application of 3.5 g placebo gel twice daily for 14 days
    Intervention: Drug: Placebo Gel
  • Placebo Comparator: HEC Placebo Gel
    Intravaginal application of 3.5 g HEC placebo gel twice daily for 14 days
    Intervention: Drug: HEC Placebo Gel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 24 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00442910
MTN-004; SPL7013-006
Yes
Professor Ian McGowan, Principal Investigator, Microbicide Trials Network
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
Study Chair: Ian McGowan, MD, PhD University of California Geffen School of Medicine
Starpharma Pty Ltd
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP