SPL7013 Gel - Male Tolerance Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Starpharma Pty Ltd
ClinicalTrials.gov Identifier:
NCT00370357
First received: August 30, 2006
Last updated: January 10, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Human Immunodeficiency Virus (HIV)
Drug: 3% w/w SPL7013 Gel (VivaGel™)
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Starpharma Pty Ltd:

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

Estimated Enrollment: 36
Study Start Date: August 2006
Study Completion Date: June 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370357

Locations
Australia, Victoria
Melbourne Sexual Health Centre
Carlton, Victoria, Australia, 3053
Sponsors and Collaborators
Starpharma Pty Ltd
Investigators
Principal Investigator: Marcus Chen, MD, PhD Melbourne Sexual Health Centre
  More Information

No publications provided

Responsible Party: Marcus Chen MD, Melbourne Sexual Health Clinic
ClinicalTrials.gov Identifier: NCT00370357     History of Changes
Other Study ID Numbers: SPL7013-002
Study First Received: August 30, 2006
Last Updated: January 10, 2008
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Administration

Keywords provided by Starpharma Pty Ltd:
Microbicide
SPL7013
VivaGel

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 19, 2014