SPL7013 Gel - Male Tolerance Study

NCT00370357 | Completed Phase 1

• 1 other identifier: SPL7013-002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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)

Keywords

Microbicide; SPL7013; VivaGel

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• All other adverse events

• Laboratory abnormalities

• Plasma concentrations of SPL7013

• Expectations and experiences of the study products described by participant interviews

Interventions

3% w/w SPL7013 Gel (VivaGel™) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Starpharma Pty Ltd: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Melbourne Sexual Health Centre

Carlton, Victoria, 3053, Australia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

astodrimer

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Marcus Chen, MD, PhD

  Melbourne Sexual Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 30, 2006
• First Posted: August 31, 2006
• Study Start: August 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: June 1, 2007
• Last Updated: January 16, 2008

Record last verified: 2008-01

Locations

AU (1)