HIV InfectionsPhase 1NCT00700284
Feasibility Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine)
A Phase 1 study testing TMC120 (dapivirine) vaginal ring in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 1 site in Belgium.
Trial summary
The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- TMC120 (dapivirine) vaginal ring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2004to Jan 2005
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female, 18-50 years, inclusive
- Willing and able to provide written informed consent
- HIV-uninfected and otherwise healthy
- Willing to abstain from sexual activity and use of vaginal products while participating in the trial
- Currently using oral contraceptives for pregnancy prevention
- Willing to use oral contraceptives as needed to avoid menstruation while taking part in this trial
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 allergy to TMC120 or to the constituents of the vaginal ring.
- History of hypersensitivity to propofol, or other contraindication to general anesthesia or sedation
- History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months.
- History of genital tract surgery within the last month
- Currently pregnant or breastfeeding, or within two months of last pregnancy outcome
Show all 10Show fewer
- Currently or within one month of participating in any other clinical research trial
- Current (during screening) diagnosis of any genital infection
- Current vulvar of vaginal symptoms
- Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine) as a Vaginal Microbicide
The purpose of this trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.
- Conditions
- HIV Infections
- Being tested
- placebo vaginal ring, TMC120 (dapivirine) vaginal ring
- Keywords
- HIV-I, Reverse transcriptase inhibitors, 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.
placebo vaginal ringDrug
vaginal ring containing no TMC120 (dapivirine)
TMC120 (dapivirine) vaginal ringDrug
vaginal ring containing 120 mg TMC120 (dapivirine)
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: placebo vaginal ring |
| B | Experimental | Not described Receives: Drug: TMC120 (dapivirine) vaginal ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability of a vaginal ring containing TMC120 (dapivirine)
Measured: 7 days
TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startOct 2004
- Primary completionJan 2005
- Study completionJan 2005
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tibotec Pharmaceutical Limited
- Investigators
- Dr Luc Van Bortel, Principal investigator, Drug Research Unit, UZ Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700284
- Sponsor's protocol ID
- IPM 001, TMC120-C130
- Status last verified
- Aug 2009
- First submitted
- 16 Jun 2008
- 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
- Phase I Study of a Vaginal Ring for Delivery of TMC120 (Dapivirine) as a Vaginal Microbicide
- ClinicalTrials.gov ID
- NCT00700284
- Acronym / sponsor ID
- IPM 001, TMC120-C130
- Conditions
- HIV Infections
- Keywords
- HIV-I, Reverse transcriptase inhibitors, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tibotec Pharmaceutical Limited
- Study start
- Oct 2004
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 18 Jun 2008 (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 trial was to evaluate the safety and feasibility of using a vaginal ring to deliver the candidate microbicide TMC120 (dapivirine). Twelve women initially underwent 7-day exposure to a placebo ring containing no investigational agent. They then underwent 7-day exposure to a ring containing 120 mg of TMC120 (dapivirine). Feasibility was assessed in terms of safety and tolerability as well as drug delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: placebo vaginal ring |
| B | Experimental | Drug: TMC120 (dapivirine) vaginal ring |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female, 18-50 years, inclusive
- Willing and able to provide written informed consent
- HIV-uninfected and otherwise healthy
- Willing to abstain from sexual activity and use of vaginal products while participating in the trial
- Currently using oral contraceptives for pregnancy prevention
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 allergy to TMC120 or to the constituents of the vaginal ring.
- History of hypersensitivity to propofol, or other contraindication to general anesthesia or sedation
- History of diagnosis of and/or treatment for a sexually transmitted disease within the last three months.
- History of genital tract surgery within the last month
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 |
|---|---|---|
| placebo vaginal ringvaginal ring containing no TMC120 (dapivirine) | Drug | A |
| TMC120 (dapivirine) vaginal ringvaginal ring containing 120 mg TMC120 (dapivirine) | Drug | B |
Primary outcome
safety and tolerability of a vaginal ring containing TMC120 (dapivirine)
Time frame: 7 days
TMC120 (dapivirine) concentrations in vaginal fluids, vaginal and cervical epithelial tissue, and plasma
Time frame: 7 days
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.
- The clinical study report synopsis can be found on the IPM website at this locationLink 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.
Dr Luc Van Bortel principal investigator
Drug Research Unit, UZ Gent
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 TMC120 (dapivirine) vaginal 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 6 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.
What does the primary outcome measure?
safety and tolerability of a vaginal ring containing TMC120 (dapivirine) (time frame: 7 days). 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 1 Sep 2009.