SPL7013 Gel - Male Tolerance Study

NCT ID: NCT00370357

Last Updated: 2008-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2007-06-30

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.

Conditions

Human Immunodeficiency Virus (HIV)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

3% w/w SPL7013 Gel (VivaGel™)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Starpharma Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Melbourne Sexual Health Clinic

Principal Investigators

Marcus Chen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Melbourne Sexual Health Centre

Locations

Melbourne Sexual Health Centre

Carlton, Victoria, Australia

Countries

Australia

Other Identifiers

SPL7013-002

Identifier Type: -

Identifier Source: org_study_id