Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women - Full Text View

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
Information provided by:	Starpharma Pty Ltd
ClinicalTrials.gov Identifier:	NCT00442910

Purpose

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	Intervention	Phase
Healthy	Drug: SPL7013 Gel Drug: Placebo Gel	Phase I

Drug Information available for: SPL 7013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Phase 1 Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women

Further study details as provided by Starpharma Pty Ltd:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	40
Study Start Date:	July 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Intravaginal application of 3.5 g SPL7013 gel twice daily for 14 days	Drug: SPL7013 Gel 3% vaginal gel
2: Placebo Comparator Intravaginal application of 3.5 g placebo gel twice daily for 14 days	Drug: Placebo Gel Placebo for SPL7013 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.

Eligibility

Ages Eligible for Study:	18 Years to 24 Years
Genders 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442910

Locations

United States, Florida
University of South Florida	Recruiting
Tampa, Florida, United States, 33606
Contact: Patricia Emmanual, MD pemmanue@health.usf.edu
Principal Investigator: Patricia Emmanuel, MD
Puerto Rico
University of Puerto Rico	Recruiting
San Juan, Puerto Rico, 00936-5067
Contact: Irma Febo, MD febo.irma@fstrf.org

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

More Information

Click here for the Microbicide Trials Network Web site This link exits the ClinicalTrials.gov site

Publications:

Balzarini J, Van Damme L. Microbicide drug candidates to prevent HIV infection. Lancet. 2007 Mar 3;369(9563):787-97. Review.

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. Review.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	MTN-004; SPL7013-006
Study First Received:	March 2, 2007
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00442910
Health Authority:	United States: Food and Drug Administration

Keywords provided by Starpharma Pty Ltd:

Safety and Acceptability

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009