Trial Outcomes & Findings for Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing. (NCT NCT00740584)

Results Overview

The HIV antiviral activity is the ability of each sample taken from the vagina (cervico-vaginal (CV) sample) to inhibit HIV virus from infecting a specific cell culture. The inhibition of HIV in the presence of the CV sample is compared to the inhibition of HIV in the cell culture with no CV sample added. This allows an assessment of the affect that the CV sample has.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

at 3 hours

Results posted on

2018-10-30

Participant Flow

12 women recruited. Details to be provided in publication, which is in process.

Open label study, no assignment.

Participant milestones

Participant milestones
Measure	Open Label, Only Arm 3%w/w SPL7013 vaginal gel (VivaGel)
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Open Label, Only Arm 3%w/w SPL7013 vaginal gel (VivaGel)
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Retention and Duration of Activity of SPL7013 (VivaGel®) After Vaginal Dosing.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label, Only Arm n=12 Participants 3%w/w SPL7013 vaginal gel (VivaGel)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Australia	12 participants n=5 Participants

PRIMARY outcome

Timeframe: at 3 hours

The HIV antiviral activity is the ability of each sample taken from the vagina (cervico-vaginal (CV) sample) to inhibit HIV virus from infecting a specific cell culture. The inhibition of HIV in the presence of the CV sample is compared to the inhibition of HIV in the cell culture with no CV sample added. This allows an assessment of the affect that the CV sample has.

Outcome measures

Outcome measures
Measure	Open Label Active n=11 Participants
HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)	96 percent anti-viral activity Inter-Quartile Range 2 • Interval 95.0 to 98.0

SECONDARY outcome

Timeframe: Approximately 13 weeks

Population: All Enrolled

Number of participants with any untoward medical occurrence in a subject administered the Investigational Product, irrespective of any perceived causality to that study product

Outcome measures

Outcome measures
Measure	Open Label Active n=12 Participants
Number of Participants With Adverse Experiences	7 Participants

Adverse Events

Open Label, Only Arm

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open Label, Only Arm n=12 participants at risk 3%w/w SPL7013 vaginal gel (VivaGel)
Reproductive system and breast disorders Related Genitourinary AEs	25.0% 3/12 • Number of events 3

Additional Information

Clinical Development Manger

Starpharma Pty Ltd

Phone: +61 3 9532 2700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No disclosure without SPL consent.
Publication restrictions are in place

Restriction type: OTHER