SPL7013 Gel - Male Tolerance Study

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Placebo Controlled Study of the Safety of 3% w/w SPL7013 Gel, Administered to the Penis of Healthy Male Volunteers Once Daily for Seven Days

Conditions
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Human Immunodeficiency Virus (HIV)

Intervention / Treatment
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* Drug: 3% w/w SPL7013 Gel (VivaGel™)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 3% w/w SPL7013 Gel (VivaGel™)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All other adverse events |  |  | 
| Laboratory abnormalities |  |  | 
| Plasma concentrations of SPL7013 |  |  | 
| Expectations and experiences of the study products described by participant interviews |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbicide, SPL7013, VivaGel