Prevention of sexual transmitted infections (STIs) including human immunodeficiency virus (HIV) Infections and Infestations Contact with and exposure to communicable diseases
Conditions
Interventions
Trial groups:
Group 1: Gel alone
Group 2: Gel plus SLS
Group 3: Placebo
The study will be divided in two parts. Part A is a short-term study using escalating gel applications (1 x, 2 x and 3 x) d
Sponsors
Laval University (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Signed an informed consent 2. Healthy female subjects aged between 18 to 49 years 3. Normal physical and gynaecological examinations 4. Normal colposcopic examination 5. Have regular menstrual cycle with 21 - 40 days between menses 6. Human immunodeficiency virus (HIV)-negative subjects and at low risk of acquiring HIV 7. At low risk of getting sexually transmitted diseases (STDs), i.e., sexually abstinent or having history of protected sexual intercourse or having a stable sexual partner 8 Agreeing to abstain from sexual intercourse from screening to the end of the study (for sexually abstinent subjects) 9. Agreeing to have a minimum of four sexual intercourses for each period of 2 weeks of gel application (for sexually active subjects)
Exclusion criteria
Exclusion criteria: 1. Clinically significant abnormal physical and/or gynaecological examination 2. Clinically significant abnormal laboratory findings 3. Allergy to applicator material (polyethylene) or to gel polymer (polyoxyethylene - polyoxypropylene) or to latex 4. Participation in any investigational study involving drugs, vaccines or microbicides in the last 30 days or participation in a study involving the invisible condom 5. History of toxic shock syndrome 6. HIV infection 7. Bacterial vaginosis or Candida or Trichomonas at time of screening 8. STDs (gonorrheae, chlamydia, syphilis, genital herpes, chancroid) at time of screening 9. Breakthrough menstrual bleeding, or vaginal bleeding during or following sexual intercourse, in the last 3 months 10. Intravenous (IV) drug use except for medical reasons in the last year 11. Pregnant at enrolment or breast-feeding 12. Having received antibiotics in the last 14 days 13. Subjects considered as unreliable or unable to understand or follow the study protocol directions 14. Use of an intrauterine device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerance measured at all visits by gynecological and colposcopic examinations 2. Nugent score 3. Clinical laboratory safety tests | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability measured at the end of gel application period by acceptability questionnaire | — |
Countries
Cameroon, Canada
Outcome results
None listed