SPL7013 Gel - Male Tolerance Study

Human Immunodeficiency Virus (HIV) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370357
• Other study ID #: SPL7013-002
• Status: Completed
• Phase: Phase 1
• First received: August 30, 2006
• Last updated: January 10, 2008
• Start date: August 2006
• Est. completion date: June 2007

Study information

• Verified date: January 2008
• Source: Starpharma Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes

Intervention

Drug:
• 3% w/w SPL7013 Gel (VivaGel™)

Locations

Country	Name	City	State
Australia	Melbourne Sexual Health Centre	Carlton	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Starpharma Pty Ltd	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant reports of genital pain, genital burning, penile itching, penile rash, penile ulceration or other genital symptoms
Primary	Erythema, vesiculation, bullous reaction, ulceration or other genital findings of the penile shaft, foreskin, glans or meatus as observed by visual examination
Secondary	All other adverse events
Secondary	Laboratory abnormalities
Secondary	Plasma concentrations of SPL7013
Secondary	Expectations and experiences of the study products described by participant interviews