HIV Infections, HSV-2 Genital Herpes
Conditions
Keywords
Prevention
Brief summary
To assess the retention and anti-viral activity (human immunodeficiency virus (HIV) and herpes simplex virus 2 (genital herpes, HSV-2) of SPL7013 in cervicovaginal samples taken up to 24 hours after administration of 3% SPL7013 in the vagina. There is no hypothesis for this study.
Interventions
A single application of VivaGel applied to the vagina on five separate occasions, each occasion separated by a minimum of 5 days.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Starpharma Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy women aged 18-45 with regular menstrual cycles, free from sexually transmitted infections and using adequate contraception
Exclusion criteria
* Any condition, including genital conditions, sexually transmitted infection, menopause, and/or allergies that would make the study participant unsuitable for the study. * Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Experiences | Approximately 13 weeks | Number of participants with any untoward medical occurrence in a subject administered the Investigational Product, irrespective of any perceived causality to that study product |
Countries
Australia
Participant flow
Recruitment details
12 women recruited. Details to be provided in publication, which is in process.
Pre-assignment details
Open label study, no assignment.
Participants by arm
| Arm | Count |
|---|---|
| Open Label, Only Arm 3%w/w SPL7013 vaginal gel (VivaGel) | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Open Label, Only Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Region of Enrollment Australia | 12 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
HIV Antiviral Activity of Each of the Cervico-vaginal Samples (Samples Taken From the Vagina Using the Softcup)
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.
Time frame: at 3 hours
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Open Label Active | 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 |
Secondary
Number of Participants With Adverse Experiences
Number of participants with any untoward medical occurrence in a subject administered the Investigational Product, irrespective of any perceived causality to that study product
Time frame: Approximately 13 weeks
Population: All Enrolled
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Label Active | Number of Participants With Adverse Experiences | 7 Participants |