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

NCT00442910 | Completed Phase 1 DMC

• 1 other identifier: MTN-004; SPL7013-006
• Study Type: interventional
• Target: 61
• Locations: 2 countries
• Sites: 3

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.

Conditions

Healthy

Keywords

Safety and Acceptability

Outcome Measures

Primary Outcomes (2)

• Incidence of abnormal genital symptoms and/or pelvic exam findings

  Throughout study

• Occurrence of adverse events and/or abnormal laboratory values

  Throughout study

Secondary Outcomes (4)

• 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

Study Arms (3)

3% SPL7013

ACTIVE COMPARATOR

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

Drug: 3% SPL7013 Gel (VivaGel)

Placebo for SPL7013 Gel

PLACEBO COMPARATOR

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

Drug: Placebo Gel

HEC Placebo Gel

PLACEBO COMPARATOR

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

Drug: HEC Placebo Gel

Interventions

3% SPL7013 Gel (VivaGel) DRUG

3% vaginal gel

Also known as: VivaGel

3% SPL7013

Placebo Gel DRUG

Placebo for SPL7013 gel

Placebo for SPL7013 Gel

HEC Placebo Gel DRUG

HEC Placebo gel intravaginally bd for 14 days

Also known as: Universal Placebo

HEC Placebo Gel

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Starpharma Pty Ltd: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Microbicide Trials Network: collaborator

Study Sites (3)

University of South Florida

Tampa, Florida, 33606, United States

Location

Center for Family Planning Research, Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213-3180, United States

Location

University of Puerto Rico

San Juan, 00936-5067, Puerto Rico

Location

Related Publications (3)

• 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.

  PMID: 17336656 BACKGROUND

• 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.

  PMID: 18203424 BACKGROUND

• 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.

  PMID: 21505316 DERIVED

MeSH Terms

Interventions

astodrimer

Study Officials

• Ian McGowan, MD, PhD

  University of California Geffen School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 5, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 24, 2010

Record last verified: 2010-06

Locations

US (2); PR (1)