Human Immunodeficiency Virus (HIV)Phase 1NCT00370357
SPL7013 Gel - Male Tolerance Study
A Phase 1 study testing 3% w/w SPL7013 Gel (VivaGel™) in people with Human Immunodeficiency Virus (HIV), run by Starpharma Pty Ltd at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)
- What is being tested?
- 3% w/w SPL7013 Gel (VivaGel™)
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2006to Jun 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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)
- Being tested
- 3% w/w SPL7013 Gel (VivaGel™)
- Keywords
- Microbicide, SPL7013, VivaGel
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% w/w SPL7013 Gel (VivaGel™)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionFeb 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Starpharma Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marcus Chen, MD, PhD, Principal investigator, Melbourne Sexual Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370357
- Sponsor's protocol ID
- SPL7013-002
- Status last verified
- Jan 2008
- First submitted
- 30 Aug 2006
- Last updated
- 16 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00370357
- Acronym / sponsor ID
- SPL7013-002
- Conditions
- Human Immunodeficiency Virus (HIV)
- Keywords
- Microbicide, SPL7013, VivaGel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- Starpharma Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Aug 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 31 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3% w/w SPL7013 Gel (VivaGel™) | Drug | – |
Primary outcome
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
4 secondary outcomes
All other adverse events
Laboratory abnormalities
Plasma concentrations of SPL7013
Expectations and experiences of the study products described by participant interviews
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Chen, MD, PhD principal investigator
Melbourne Sexual Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3% w/w SPL7013 Gel (VivaGel™) in people with Human Immunodeficiency Virus (HIV), run by Starpharma Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant reports of genital pain, genital burning, penile itching, penile rash, penile ulceration or other genital symptoms. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2008; AzTrials last refreshed its copy on 28 Oct 2026.