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

Starpharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: HSV-2 Genital Herpes; HIV Infections

Treatments: Drug: 3% SPL7013 Gel (VivaGel)

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00740584

NIH contract HHSN266200500042C

DAIDS ES number 10730

SPL7013-003

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Open Label, only arm

Experimental group

Description:

3%w/w SPL7013 vaginal gel (VivaGel)

Treatment:

Drug: 3% SPL7013 Gel (VivaGel)