SPL7013 Gel - Male Tolerance Study - Full Text View

Sponsors and Collaborators:	Starpharma Pty Ltd National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	Starpharma Pty Ltd
ClinicalTrials.gov Identifier:	NCT00370357

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 I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety 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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: SPL 7013

U.S. FDA Resources

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

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

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

Marcus Chen, MD, PhD

Melbourne Sexual Health Centre

More Information

No publications provided

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

Keywords provided by Starpharma Pty Ltd:

Microbicide
SPL7013
VivaGel

Study placed in the following topic categories:

Virus Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Healthy
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 09, 2009