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SPL7013 Gel - Male Tolerance Study

Primary Purpose

Human Immunodeficiency Virus (HIV)

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
3% w/w SPL7013 Gel (VivaGel™)
Sponsored by
Starpharma Pty Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus (HIV) focused on measuring Microbicide, SPL7013, VivaGel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Melbourne Sexual Health Centre

Outcomes

Primary Outcome Measures

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

All other adverse events
Laboratory abnormalities
Plasma concentrations of SPL7013
Expectations and experiences of the study products described by participant interviews

Full Information

First Posted
August 30, 2006
Last Updated
January 10, 2008
Sponsor
Starpharma Pty Ltd
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00370357
Brief Title
SPL7013 Gel - Male Tolerance Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Starpharma Pty Ltd
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV)
Keywords
Microbicide, SPL7013, VivaGel

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
3% w/w SPL7013 Gel (VivaGel™)
Primary Outcome Measure Information:
Title
Participant reports of genital pain, genital burning, penile itching, penile rash, penile ulceration or other genital symptoms
Title
Erythema, vesiculation, bullous reaction, ulceration or other genital findings of the penile shaft, foreskin, glans or meatus as observed by visual examination
Secondary Outcome Measure Information:
Title
All other adverse events
Title
Laboratory abnormalities
Title
Plasma concentrations of SPL7013
Title
Expectations and experiences of the study products described by participant interviews

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Chen, MD, PhD
Organizational Affiliation
Melbourne Sexual Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Melbourne Sexual Health Centre
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

SPL7013 Gel - Male Tolerance Study

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