HIV InfectionsEarly Phase 1NCT00469170
A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method
A Early Phase 1 study testing intravaginal ring in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 4 sites in 2 countries.
Trial summary
The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active women. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- intravaginal ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2007to Feb 2010
- Phase
- Early 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, age 18-35 years
- Willing and able to provide written informed consent
- HIV-uninfected and otherwise healthy
- Self-reported sexually active
- On a stable hormonal contraceptive regimen
- Regular menstrual cycle
- Willing to refrain from use of vaginal products or objects during the study
Who cannot join
- Currently pregnant or last pregnancy within 3 months prior to enrollment
- Currently breast-feeding
- Participated in any other research study within 30 days prior to enrollment;
- Symptomatic untreated vaginal infections within 2 weeks prior to enrollment
- Presence of abnormal physical finding on the vulva, vaginal walls or cervix
- History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction;
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- Pap smear result at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation
- Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
- Any serious acute, chronic or progressive disease
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
South Africa3 sites
Desmond Tutu HIV Foundation, Masiphumelele
Cape Town, 7975
South African Medical Research Council
Durban, KwaZulu-Natal, 4067
Reproductive Health & HIV Research Unit - Sheshisani IPM Clinic
Yeoville, Johannesburg
About this study
Official title: A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method for the Prevention of HIV Infection in Women
The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active women.
- Conditions
- HIV Infections
- Being tested
- intravaginal ring
- Keywords
- HIV-1, HIV seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravaginal ringDevice
silicone elastomer intravaginal ring containing no drug product
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | vaginal ring first 12 weeks \& observational safety last 12 weeks Receives: Device: intravaginal ring |
| B | Experimental | observational safety first 12 weeks \& vaginal ring last 12 weeks Receives: Device: intravaginal ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary measure of acceptability will be defined as the proportion of women indicating that they would use the study product if it is found to prevent HIV.
Measured: 3 months
The primary measure of safety will be the proportion of women who have abnormal observations during the pelvic/speculum examinations and the proportion of women who experience adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2007 (estimated)
- Study startMar 2007
- Primary completionFeb 2010
- Study completionFeb 2010
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.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Annalene Nel, Study director, Beijing Immupeutics Medicine Technology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469170
- Sponsor's protocol ID
- IPM 011
- Status last verified
- Nov 2010
- First submitted
- 3 May 2007
- Last updated
- 15 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method for the Prevention of HIV Infection in Women
- ClinicalTrials.gov ID
- NCT00469170
- Acronym / sponsor ID
- IPM 011
- Conditions
- HIV Infections
- Keywords
- HIV-1, HIV seronegativity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 4 May 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.
The proposed study is a multi-centre, open-label crossover study to assess the safety and acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a 12 week period in 200 healthy, sexually active women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: intravaginal ringvaginal ring first 12 weeks \& observational safety last 12 weeks |
| B | Experimental | Device: intravaginal ringobservational safety first 12 weeks \& vaginal ring last 12 weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female, age 18-35 years
- Willing and able to provide written informed consent
- HIV-uninfected and otherwise healthy
- Self-reported sexually active
- On a stable hormonal contraceptive regimen
Key exclusion criteria (9 listed)
- Currently pregnant or last pregnancy within 3 months prior to enrollment
- Currently breast-feeding
- Participated in any other research study within 30 days prior to enrollment;
- Symptomatic untreated vaginal infections within 2 weeks prior to enrollment
- Presence of abnormal physical finding on the vulva, vaginal walls or cervix
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 |
|---|---|---|
| intravaginal ringsilicone elastomer intravaginal ring containing no drug product | Device | A, B |
Primary outcome
The primary measure of acceptability will be defined as the proportion of women indicating that they would use the study product if it is found to prevent HIV.
Time frame: 3 months
The primary measure of safety will be the proportion of women who have abnormal observations during the pelvic/speculum examinations and the proportion of women who experience adverse events
Time frame: 3 months
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 15 Nov 2010.
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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.
Dr. Annalene Nel study director
Beijing Immupeutics Medicine Technology Limited
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing intravaginal ring in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 4 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 7 inclusion and 9 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 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Africa, Tanzania. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The primary measure of acceptability will be defined as the proportion of women indicating that they would use the study product if it is found to prevent HIV. (time frame: 3 months). 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 15 Nov 2010.