HIV InfectionsPhase 1/2NCT00136643
Safety, Tolerance and Acceptability Trial of the Invisible Condom® in Healthy Women
A Phase 1/2 study testing Invisible Condom® in people with HIV Infections and Sexually Transmitted Diseases, run by Laval University at 1 site in Cameroon.
Trial summary
The objectives of this clinical study are to evaluate the extended safety, tolerance and acceptability of a vaginal gel formulation when applied in 452 healthy women volunteers. This vaginal formulation was shown to be well tolerated in a previous smaller clinical study. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- Invisible Condom®
- How many people
- 452 participants
- Where
- 1 siteCameroon
- Study dates
- Jun 2005to Jul 2007
- Phase
- Phase 1/2
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign an informed consent
- Healthy female subjects aged between 18 to 49. Healthy female subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination and laboratory tests.
- Normal physical and gynecological examinations
- Normal colposcopic examination
- Have regular menstrual cycle with 21-40 days between menses
- HIV-negative subjects and at low risk of acquiring HIV
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- At low risk of getting STIs (i.e. sexually abstinent or having history of protected sexual intercourse or having a stable sexual partner). Sexual intercourse is defined here as vaginal penetration. Stable sexual partner is defined as the same sexual partner for the length of the study.
- Agreeing to abstain from sexual intercourse from screening to the end of the study (for sexually abstinent subjects).
- Agreeing to have sexual intercourse a minimum of 4 times for each period of two weeks of gel application (for sexually active subjects)
Who cannot join
- Clinically significant abnormal physical and/or gynecological examination
- Clinically significant abnormal laboratory findings
- Allergy to applicator material (polyethylene) or to gel polymer (polyoxyethylene-polyoxypropylene) or to latex
- Participation in any investigational study involving drugs, vaccines or microbicides in the last 30 days
- History of toxic shock syndrome
- HIV infection
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- Bacterial vaginosis or Candida or Trichomonas vaginitis at time of screening
- STIs (gonorrhea, chlamydia, syphilis, genital herpes, chancroid) at time of screening
- Breakthrough menstrual bleeding, or vaginal bleeding during or following sexual intercourse, in the last 3 months
- Intravenous (IV) drug use except for medical reasons in the last year
- Pregnant at enrolment or breast-feeding
- Having received antibiotics in the last 14 days
- Subjects considered as unreliable or unable to understand or follow the study protocol directions
- Use of an intrauterine device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerance and Acceptability of a Vaginal Gel Containing Sodium Lauryl Sulfate (Invisible Condom®) in Healthy Female Subjects
The objectives of this clinical study are to evaluate the extended safety, tolerance and acceptability of a vaginal gel formulation when applied in 452 healthy women volunteers. This vaginal formulation was shown to be well tolerated in a previous smaller clinical study. The formulation is being developed as a microbicide for the prevention of sexually transmitted infections (STIs) including HIV.
Read the detailed description
Objectives: The objectives of this Phase I/II clinical trial are to evaluate the safety, tolerance and acceptability of a gel formulation containing sodium lauryl sulfate (SLS) (compared to gel alone and placebo) when applied intravaginally in healthy volunteers.
Design: In part A of the protocol, three groups: gel alone, gel plus SLS, and placebo will be tested for safety, tolerance and acceptability when applied intravaginally once, twice or three times daily for 14 days in 252 healthy subjects. The volunteers will be divided as follow: 36 sexually abstinent healthy subjects (12 per group) will apply the gel, gel plus SLS or the placebo once daily for 14 days; 72 sexually active healthy subjects (24 per group) will apply the gel, gel plus SLS or the placebo once daily for 14 days; 72 sexually active healthy subjects (24 per group) will apply the gel, gel plus SLS or the placebo twice daily for 14 days and 72 sexually active healthy subjects (24 per group) will apply the gel, gel plus SLS or the placebo three times daily for 14 days. The gel will be applied between menses. For the sexually active group, the gel should be applied less than 1 hour before sexual intercourse, if planned. Subjects will have vaginal intercourse a minimum of 4 times in a 2-week period of gel application.
In part B of the protocol, the extended safety of the gel alone, gel plus SLS and placebo will be studied when applied intravaginally twice daily for 8 weeks in sexually active healthy subjects. In this part B (actually represents Phase II of the trial), 80 healthy sexually active subjects for the gel alone group and 80 subjects for the gel + SLS group and 40 subjects for the placebo group, will be studied. The part B involves the participation of a total of 200 subjects. Subjects will have vaginal intercourse a minimum of 4 times in a 2-week period of gel application. The gel will be applied between menses. The gel should be applied less than 1 hour before sexual intercourse, if planned, but no more than twice a day.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- Invisible Condom®
- Keywords
- microbicide, Women, Prevention, HIV, STIs, HIV Seronegativity, prevention of sexually transmitted infections including HIV.
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invisible Condom®Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerance outcomes: Subjective assessment; Objective assessment
Secondary outcomes (1)
Acceptability assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startJun 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 452 participants
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Centre de Recheche du Centre Hospitalier Université Laval
- Investigators
- Michel G. Bergeron, MD, FRCPC, Principal investigator, Prof. and Director of Infectious Diseases Research Center, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136643
- Sponsor's protocol ID
- CRI-INV.06
- Other IDs
- FRN: 67531
- Status last verified
- Oct 2007
- First submitted
- 26 Aug 2005
- Last updated
- 10 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerance and Acceptability of a Vaginal Gel Containing Sodium Lauryl Sulfate (Invisible Condom®) in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT00136643
- Acronym / sponsor ID
- CRI-INV.06
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Keywords
- microbicide, Women, Prevention, HIV, STIs, HIV Seronegativity, prevention of sexually transmitted infections including HIV.
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Centre de Recheche du Centre Hospitalier Université Laval
- Study start
- Jun 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 29 Aug 2005 (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 objectives of this clinical study are to evaluate the extended safety, tolerance and acceptability of a vaginal gel formulation when applied in 452 healthy women volunteers. This vaginal formulation was shown to be well tolerated in a previous smaller clinical study. The formulation is being developed as a microbicide for the prevention of sexually transmitted infections (STIs) including HIV.
Detailed description
Objectives: The objectives of this Phase I/II clinical trial are to evaluate the safety, tolerance and acceptability of a gel formulation containing sodium lauryl sulfate (SLS) (compared to gel alone and placebo) when applied intravaginally in healthy volunteers.
Design: In part A of the protocol, three groups: gel alone, gel plus SLS, and placebo will be tested for safety, tolerance and acceptability when applied intravaginally once, twice or three times daily for 14 days in 252 healthy subjects. The volunteers will be divided as follow: 36 sexually abstinent healthy subjects (12 per group) will apply the gel, gel plus SLS or the placebo once daily for 14 days; 72 sexually active healthy subjects (24 per group) will apply the gel, gel plus SLS or the placebo once daily for 14 days; 72 sexually active healthy subjects (24 per group) will apply the gel, gel plus SLS or the placebo twice daily for 14 days and 72 sexually active healthy subjects (24 per group) will apply the gel, gel plus SLS or the placebo three times daily for 14 days. The gel will be applied between menses. For the sexually active group, the gel should be applied less than 1 hour before sexual intercourse, if planned. Subjects will have vaginal intercourse a minimum of 4 times in a 2-week period of gel application.
In part B of the protocol, the extended safety of the gel alone, gel plus SLS and placebo will be studied when applied intravaginally twice daily for 8 weeks in sexually active healthy subjects. In this part B (actually represents Phase II of the trial), 80 healthy sexually active subjects for the gel alone group and 80 subjects for the gel + SLS group and 40 subjects for the placebo group, will be studied. The part B involves the participation of a total of 200 subjects. Subjects will have vaginal intercourse a minimum of 4 times in a 2-week period of gel application. The gel will be applied between menses. The gel should be applied less than 1 hour before sexual intercourse, if planned, but no more than twice a day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Sign an informed consent
- Healthy female subjects aged between 18 to 49. Healthy female subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination and laboratory tests.
- Normal physical and gynecological examinations
- Normal colposcopic examination
- Have regular menstrual cycle with 21-40 days between menses
Key exclusion criteria (14 listed)
- Clinically significant abnormal physical and/or gynecological examination
- Clinically significant abnormal laboratory findings
- Allergy to applicator material (polyethylene) or to gel polymer (polyoxyethylene-polyoxypropylene) or to latex
- Participation in any investigational study involving drugs, vaccines or microbicides in the last 30 days
- History of toxic shock syndrome
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 |
|---|---|---|
| Invisible Condom® | Drug | – |
Primary outcome
Safety and tolerance outcomes: Subjective assessment; Objective assessment
1 secondary outcome
Acceptability assessment
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 10 Oct 2007.
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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.
Michel G. Bergeron, MD, FRCPC principal investigator
Prof. and Director of Infectious Diseases Research Center, Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Invisible Condom® in people with HIV Infections and Sexually Transmitted Diseases, run by Laval University at 1 site in Cameroon.
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 9 inclusion and 14 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 10 Oct 2007. 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 Cameroon. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and tolerance outcomes: Subjective assessment; Objective assessment. 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 10 Oct 2007.