HIV InfectionsPhase 1NCT00469768
A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium
A Phase 1 study testing dapivirine reservoir intravaginal ring and dapivirine matrix intravaginal ring in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 1 site in Belgium.
Trial summary
IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess safety and tolerability compared to placebo 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?
- dapivirine reservoir intravaginal ring and dapivirine matrix intravaginal ring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- May 2007to Aug 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between 18 and 35 years of age
- Willing and able to give written informed consent
- Available for all visits and consent to follow all procedures scheduled for the study
- Healthy and HIV-negative as determined by a HIV-1 ELISA test at time of enrollment;
- Willing to abstain from sexual activity for the duration of the study
- Willing to use oral contraceptives to avoid menstruation while taking part in this study or on long-acting progestins for 6 months prior to enrollment
- Upon pelvic / speculum examination at enrollment, the cervix and vagina appear normal
- Willing to refrain from use of vaginal products or objects for the duration of the study.
Who cannot join
- History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements;
- History of sensitivity / allergy to latex, dapivirine or to the constituents of the vaginal ring (i.e. silicone elastomer)
- Currently pregnant or breast-feeding, or within three months of last pregnancy outcome
- Currently or within one month of participating in any other clinical research study
- History or diagnosis of and / or treatment for a sexually transmitted disease within the last three months
- History of genital tract surgery within the last month
Show all 10Show fewer
- Current diagnosis of sexually transmitted infections (Gonorrhea, Chlamydia and Trichomonas)
- Current vulvar or vaginal symptoms / abnormalities that could influence the study results
- History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last three months;
- Smoking more than 10 cigarettes per day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Safety and Pharmacokinetic Study in Healthy HIV-negative Women to Assess the Delivery of Dapivirine From Matrix and Reservoir Intravaginal Rings Each Containing 25 mg of Dapivirine
IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess safety and tolerability compared to placebo
- Conditions
- HIV Infections
- Being tested
- dapivirine reservoir intravaginal ring, dapivirine matrix intravaginal ring, placebo intravaginal ring
- Keywords
- HIV-1 infection, 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.
dapivirine reservoir intravaginal ringDrug
a silicone elastomer reservoir ring containing 25mg of dapivirine
dapivirine matrix intravaginal ringDrug
a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine
placebo intravaginal ringOther
a silicone elastomer intravaginal ring containing no dapivirine
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: dapivirine matrix intravaginal ring |
| B | Experimental | Not described Receives: Drug: dapivirine reservoir intravaginal ring |
| C | Placebo comparator | Not described Receives: Other: placebo intravaginal ring |
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 startMay 2007
- Study completionAug 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.
- 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
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Annalene Nel, Study director, International Partnership for Microbicides (IPM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00469768
- Sponsor's protocol ID
- IPM 018
- Status last verified
- Aug 2009
- First submitted
- 3 May 2007
- Last updated
- 1 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Safety and Pharmacokinetic Study in Healthy HIV-negative Women to Assess the Delivery of Dapivirine From Matrix and Reservoir Intravaginal Rings Each Containing 25 mg of Dapivirine
- ClinicalTrials.gov ID
- NCT00469768
- Acronym / sponsor ID
- IPM 018
- Conditions
- HIV Infections
- Keywords
- HIV-1 infection, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Study completion
- Aug 2007 (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.
IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess safety and tolerability compared to placebo
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: dapivirine matrix intravaginal ring |
| B | Experimental | Drug: dapivirine reservoir intravaginal ring |
| C | Placebo comparator | Other: placebo intravaginal ring |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women between 18 and 35 years of age
- Willing and able to give written informed consent
- Available for all visits and consent to follow all procedures scheduled for the study
- Healthy and HIV-negative as determined by a HIV-1 ELISA test at time of enrollment;
- Willing to abstain from sexual activity for the duration of the study
Key exclusion criteria (10 listed)
- History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements;
- History of sensitivity / allergy to latex, dapivirine or to the constituents of the vaginal ring (i.e. silicone elastomer)
- Currently pregnant or breast-feeding, or within three months of last pregnancy outcome
- Currently or within one month of participating in any other clinical research study
- History or diagnosis of and / or treatment for a sexually transmitted disease within the last three months
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 |
|---|---|---|
| dapivirine reservoir intravaginal ringa silicone elastomer reservoir ring containing 25mg of dapivirine | Drug | B |
| dapivirine matrix intravaginal ringa silicone elastomer matrix intravaginal ring containing 25mg of dapivirine | Drug | A |
| placebo intravaginal ringa silicone elastomer intravaginal ring containing no dapivirine | Other | C |
Primary outcome
Not reported in the source record.
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 1 Sep 2009.
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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
International Partnership for Microbicides (IPM)
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 dapivirine reservoir intravaginal ring and dapivirine matrix intravaginal ring in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 1 site in Belgium.
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 8 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 1 Sep 2009. 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 Belgium. 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.
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 1 Sep 2009.