HealthyPhase 1NCT00442910
Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women
A Phase 1 study testing 3% SPL7013 Gel (VivaGel) in people with Healthy, run by Starpharma Pty Ltd at 3 sites in 2 countries.
Trial summary
There is an urgent need for HIV prevention methods that women can initiate and control themselves. Topical microbicides, substances that kill microbes, represent one such method. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 3% SPL7013 Gel (VivaGel)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2007to Dec 2009
- 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 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV-uninfected
- General good health
- Normal Pap result within 12 months prior to study entry
- Predictable menstrual cycle with at least 21 days between menses
- Sexually active
- Willing to use effective methods of contraception for the duration of the study. More information on this criterion can be found in the protocol.
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- Willing to abstain from oral-vaginal and penile-anal intercourse for the duration of the study
- Willing to not use other intravaginal products and/or devices for 72 hours prior to study entry through Week 3
- Agree to have partner use condoms provided by study for each act of intercourse during study participation
- Willing to undergo colposcopy if determined necessary by investigator
- Agree to not participate in other drug or device studies during study participation
Who cannot join
- History of adverse reaction to latex or to any component of the study products
- History of male sex partner having an allergic reaction to latex
- Any abnormal finding on physical or pelvic examination
- Sexually transmitted infection (STI) or reproductive tract infection. More information on this criterion is available in the protocol.
- Diagnosed with STI within 6 months prior to study entry
- Use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to study entry
Show all 11Show fewer
- Gynecological surgical procedure within 90 days prior to study entry
- Certain abnormal laboratory values. More information on this criterion is available in the protocol.
- Received non-therapeutic intravenous drugs within 12 months prior to study entry
- Any social or medical condition, that, in the opinion of the investigator, would interfere with the study
- Pregnant of breastfeeding
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Center for Family Planning Research, Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213-3180
University of South Florida
Tampa, Florida, 33606
About this study
Official title: Phase 1 Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women
There is an urgent need for HIV prevention methods that women can initiate and control themselves. Topical microbicides, substances that kill microbes, represent one such method. The purpose of this study is to assess the safety and to evaluate the acceptability of 3% w/w SPL7013 gel, a topical microbicide, when administered intravaginally for 14 consecutive days in healthy, sexually active HIV uninfected women.
Read the detailed description
Women continue to comprise a growing proportion of the new HIV infections around the world. A growing body of data suggests that a safe and effective topical microbicide will be a real option of prevention for women in the future. The purpose of this study is to assess the safety and acceptability of 3% SPL7013 Gel when administered intravaginally, twice daily for 14 consecutive days in healthy, sexually-active, HIV-uninfected women.
The expected duration of this study for each participant is 21 days. Study participants will be randomly assigned to one of two arms. Participants in Arm 1 will apply 3.5 g of SPL7013 gel intravaginally twice daily for 14 consecutive days. Participants in Arm 2 will apply a placebo gel intravaginally twice daily for 14 consecutive days. Starpharma produces SPL7013 gel (VivaGel) and will provide it for this study.
After enrollment, participants will attend three study visits. These visits will occur on Days 7, 14, and 21. A follow-up safety visit will occur if necessary. Medical and menstrual history, targeted physical exam, urine and blood collection, cervical swabs, and vaginal smears will occur at all visits. A colposcopy will occur at least once. On Day 2, participants will take part in a phone assessment.
- Conditions
- Healthy
- Being tested
- 3% SPL7013 Gel (VivaGel), Placebo Gel, HEC Placebo Gel
- Keywords
- Safety and Acceptability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% SPL7013 Gel (VivaGel)Drug
Also called VivaGel
3% vaginal gel
Placebo GelDrug
Placebo for SPL7013 gel
HEC Placebo GelDrug
Also called Universal Placebo
HEC Placebo gel intravaginally bd for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 3% SPL7013 | Active comparator | Intravaginal application of 3.5 g SPL7013 gel twice daily for 14 days Receives: Drug: 3% SPL7013 Gel (VivaGel) |
| Placebo for SPL7013 Gel | Placebo comparator | Intravaginal application of 3.5 g placebo gel twice daily for 14 days Receives: Drug: Placebo Gel |
| HEC Placebo Gel | Placebo comparator | Intravaginal application of 3.5 g HEC placebo gel twice daily for 14 days Receives: Drug: HEC Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of abnormal genital symptoms and/or pelvic exam findings
Measured: Throughout study
Occurrence of adverse events and/or abnormal laboratory values
Measured: Throughout study
Secondary outcomes (4)
Changes in vaginal microflora
Measured: Throughout study
Proportion of participants who report an 80% or greater adherence rate
Measured: At Day 7 and Day 14
Proportion of participants who say they would be very likely to use the study product in the future
Measured: At Day 14
Reported positive and negative aspects of using study product
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Starpharma Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Microbicide Trials Network
- Investigators
- Ian McGowan, MD, PhD, Study chair, University of California Geffen School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442910
- Sponsor's protocol ID
- MTN-004; SPL7013-006
- Status last verified
- Jun 2010
- First submitted
- 2 Mar 2007
- Last updated
- 24 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Balzarini J, Van Damme L. Microbicide drug candidates to prevent HIV infection. Lancet. 2007 Mar 3;369(9563):787-797. doi: 10.1016/S0140-6736(07)60202-5.
PubMed 17336656Rupp R, Rosenthal SL, Stanberry LR. VivaGel (SPL7013 Gel): a candidate dendrimer--microbicide for the prevention of HIV and HSV infection. Int J Nanomedicine. 2007;2(4):561-6.
PubMed 18203424McGowan I, Gomez K, Bruder K, Febo I, Chen BA, Richardson BA, Husnik M, Livant E, Price C, Jacobson C; MTN-004 Protocol Team. Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004). AIDS. 2011 May 15;25(8):1057-64. doi: 10.1097/QAD.0b013e328346bd3e.
PubMed 21505316
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Safety and Acceptability of 3% w/w SPL7013 Gel (VivaGel™) Applied Vaginally in Sexually Active Young Women
- ClinicalTrials.gov ID
- NCT00442910
- Acronym / sponsor ID
- MTN-004; SPL7013-006
- Conditions
- Healthy
- Keywords
- Safety and Acceptability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Starpharma Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Microbicide Trials Network
- Study start
- Jul 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Mar 2007 (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.
There is an urgent need for HIV prevention methods that women can initiate and control themselves. Topical microbicides, substances that kill microbes, represent one such method. The purpose of this study is to assess the safety and to evaluate the acceptability of 3% w/w SPL7013 gel, a topical microbicide, when administered intravaginally for 14 consecutive days in healthy, sexually active HIV uninfected women.
Detailed description
Women continue to comprise a growing proportion of the new HIV infections around the world. A growing body of data suggests that a safe and effective topical microbicide will be a real option of prevention for women in the future. The purpose of this study is to assess the safety and acceptability of 3% SPL7013 Gel when administered intravaginally, twice daily for 14 consecutive days in healthy, sexually-active, HIV-uninfected women.
The expected duration of this study for each participant is 21 days. Study participants will be randomly assigned to one of two arms. Participants in Arm 1 will apply 3.5 g of SPL7013 gel intravaginally twice daily for 14 consecutive days. Participants in Arm 2 will apply a placebo gel intravaginally twice daily for 14 consecutive days. Starpharma produces SPL7013 gel (VivaGel) and will provide it for this study.
After enrollment, participants will attend three study visits. These visits will occur on Days 7, 14, and 21. A follow-up safety visit will occur if necessary. Medical and menstrual history, targeted physical exam, urine and blood collection, cervical swabs, and vaginal smears will occur at all visits. A colposcopy will occur at least once. On Day 2, participants will take part in a phone assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3% SPL7013 | Active comparator | Drug: 3% SPL7013 Gel (VivaGel)Intravaginal application of 3.5 g SPL7013 gel twice daily for 14 days |
| Placebo for SPL7013 Gel | Placebo comparator | Drug: Placebo GelIntravaginal application of 3.5 g placebo gel twice daily for 14 days |
| HEC Placebo Gel | Placebo comparator | Drug: HEC Placebo GelIntravaginal application of 3.5 g HEC placebo gel twice daily for 14 days |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- HIV-uninfected
- General good health
- Normal Pap result within 12 months prior to study entry
- Predictable menstrual cycle with at least 21 days between menses
- Sexually active
Key exclusion criteria (11 listed)
- History of adverse reaction to latex or to any component of the study products
- History of male sex partner having an allergic reaction to latex
- Any abnormal finding on physical or pelvic examination
- Sexually transmitted infection (STI) or reproductive tract infection. More information on this criterion is available in the protocol.
- Diagnosed with STI within 6 months prior to study entry
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% SPL7013 Gel (VivaGel)Also: VivaGel3% vaginal gel | Drug | 3% SPL7013 |
| Placebo GelPlacebo for SPL7013 gel | Drug | Placebo for SPL7013 Gel |
| HEC Placebo GelAlso: Universal PlaceboHEC Placebo gel intravaginally bd for 14 days | Drug | HEC Placebo Gel |
Primary outcome
Incidence of abnormal genital symptoms and/or pelvic exam findings
Time frame: Throughout study
Occurrence of adverse events and/or abnormal laboratory values
Time frame: Throughout study
4 secondary outcomes
Changes in vaginal microflora
Time frame: Throughout study
Proportion of participants who report an 80% or greater adherence rate
Time frame: At Day 7 and Day 14
Proportion of participants who say they would be very likely to use the study product in the future
Time frame: At Day 14
Reported positive and negative aspects of using study product
Time frame: Throughout study
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 24 Jun 2010.
- Background: PubMed 17336656Balzarini J, Van Damme L. Microbicide drug candidates to prevent HIV infection. Lancet. 2007 Mar 3;369(9563):787-797. doi: 10.1016/S0140-6736(07)60202-5.
- Background: PubMed 18203424Rupp R, Rosenthal SL, Stanberry LR. VivaGel (SPL7013 Gel): a candidate dendrimer--microbicide for the prevention of HIV and HSV infection. Int J Nanomedicine. 2007;2(4):561-6.
- Derived from this study: PubMed 21505316McGowan I, Gomez K, Bruder K, Febo I, Chen BA, Richardson BA, Husnik M, Livant E, Price C, Jacobson C; MTN-004 Protocol Team. Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004). AIDS. 2011 May 15;25(8):1057-64. doi: 10.1097/QAD.0b013e328346bd3e.
- Click here for the Microbicide Trials Network Web siteLink provided by the sponsor.
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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.
Ian McGowan, MD, PhD study chair
University of California Geffen School of Medicine
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3% SPL7013 Gel (VivaGel) in people with Healthy, run by Starpharma Pty Ltd at 3 sites in 2 countries.
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 11 inclusion and 11 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 24 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. 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?
Incidence of abnormal genital symptoms and/or pelvic exam findings (time frame: Throughout study). 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?
On the ClinicalTrials.gov record for NCT00442910, which also lists 3 linked publications.
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 24 Jun 2010.