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

Healthy Clinical Trial

Official title:

Phase 1 Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442910
• Other study ID #: MTN-004; SPL7013-006
• Status: Completed
• Phase: Phase 1
• First received: March 2, 2007
• Last updated: June 22, 2010
• Start date: July 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2010
• Source: Starpharma Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 24 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 3% SPL7013 Gel (VivaGel)
3% vaginal gel
• Placebo Gel
Placebo for SPL7013 gel
• HEC Placebo Gel
HEC Placebo gel intravaginally bd for 14 days

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico	San Juan
United States	Center for Family Planning Research, Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	University of South Florida	Tampa	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Starpharma Pty Ltd	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Microbicide Trials Network, National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of abnormal genital symptoms and/or pelvic exam findings		Throughout study	Yes
Primary	Occurrence of adverse events and/or abnormal laboratory values		Throughout study	Yes
Secondary	Changes in vaginal microflora		Throughout study	No
Secondary	Proportion of participants who report an 80% or greater adherence rate		At Day 7 and Day 14	No
Secondary	Proportion of participants who say they would be very likely to use the study product in the future		At Day 14	No
Secondary	Reported positive and negative aspects of using study product		Throughout study	No

External Links

•   Click here for the Microbicide Trials Network Web site