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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 3% SPL7013 Gel (VivaGel); Drug: Placebo Gel; Drug: HEC Placebo Gel

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
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00936-5067
    • University of Puerto Rico
• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213-3180
      • Center for Family Planning Research, Magee-Womens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 22 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: Universal Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Starpharma Pty Ltd
• Collaborators: 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

Publications and helpful links

General Publications

• Balzarini J, Van Damme L. Microbicide drug candidates to prevent HIV infection. Lancet. 2007 Mar 3;369(9563):787-797. doi: 10.1016/S0140-6736(07)60202-5.
• Rupp R, Rosenthal SL, Stanberry LR. VivaGel (SPL7013 Gel): a candidate dendrimer--microbicide for the prevention of HIV and HSV infection. Int J Nanomedicine. 2007;2(4):561-6.
• McGowan I, Gomez K, Bruder K, Febo I, Chen BA, Richardson BA, Husnik M, Livant E, Price C, Jacobson C; MTN-004 Protocol Team. Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004). AIDS. 2011 May 15;25(8):1057-64. doi: 10.1097/QAD.0b013e328346bd3e.

Helpful Links

• Click here for the Microbicide Trials Network Web site

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: March 2, 2007
• First Submitted That Met QC Criteria: March 2, 2007
• First Posted (Estimate): March 5, 2007

Study Record Updates

• Last Update Posted (Estimate): June 24, 2010
• Last Update Submitted That Met QC Criteria: June 22, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Safety and Acceptability
• Other Study ID Numbers: MTN-004; SPL7013-006