Human Immunodeficiency Virus (HIV)
Conditions
Keywords
Microbicide, SPL7013, VivaGel
Brief summary
The purpose of this study is to determine if SPL7013 Gel (VivaGel™) is safe when applied topically once a day for seven consecutive days to the shaft and glans of the penis in healthy male volunteers. The study will compare the safety of SPL7013 Gel on the penile epithelium and urethral mucosa to the safety of a placebo gel. The study will also assess the systemic safety of SPL7013 Gel, systemic absorption of the active ingredient of SPL7013 Gel, and the acceptability of the study products to the male volunteers.
Interventions
DRUG3% w/w SPL7013 Gel (VivaGel™)
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Starpharma Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provision of written informed consent * Healthy males aged 18 years or older * HIV negative * Reports vaginal intercourse in the past 12 months * Agrees to abstain from vaginal, anal (receptive and insertive) and oral sexual intercourse, and agrees to refrain from masturbation during the 7 days of product use until after the End-of-Treatment (Day 7) study visit
Exclusion criteria
* Known or suspected allergy to any component of the study products or similar ingredients in other products * History of significant drug reaction or allergy * Recent history (within 12 months) or presence at screening of contact dermatitis or other dermatological condition * Recent history (within three months of Screening) of a sexually transmitted infection (STI) * Current signs or symptoms of UTI and/or STI at Screening or Baseline * Positive urine leukocyte esterase test (≥ trace) * Biochemical and/or haematological parameters outside the laboratory's normal reference ranges at Screening * Evidence of genital piercing, ulceration, genital dermatoses, tinea cruris or other dermatological condition of the genitalia or upper thighs * Genital pain or discomfort at Screening or Baseline * Any other abnormal finding on physical examination or other medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant reports of genital pain, genital burning, penile itching, penile rash, penile ulceration or other genital symptoms | — |
| Erythema, vesiculation, bullous reaction, ulceration or other genital findings of the penile shaft, foreskin, glans or meatus as observed by visual examination | — |
Secondary
| Measure | Time frame |
|---|---|
| All other adverse events | — |
| Laboratory abnormalities | — |
| Plasma concentrations of SPL7013 | — |
| Expectations and experiences of the study products described by participant interviews | — |
Countries
Australia
Outcome results
None listed