HIV InfectionsPhase 1NCT00304642
A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel
A Phase 1 study testing dapivirine (TMC120) vaginal gel in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 1 site in South Africa.
Trial summary
Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy HIV-negative women ages 18 to 50. 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?
- dapivirine (TMC120) vaginal gel
- How many people
- 18 participants
- Where
- 1 siteSouth Africa
- Study dates
- Nov 2005to not given
- 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
- HIV-negative
- Willing to participate and sign and informed consent form.
- Willing to be tested for HIV and to use an experimental vaginal gel.
- Willing to use a reliable form of contraception during the study.
- Willing to undergo pelvic examinations with colposcopy according to the protocol throughout the study.
- Normal cervical assessment.
- Willing to abstain from using any vaginal product (other than the study product).
- Willing to be sexually abstinent from Day 1 until completion of study product use on Day 10.
Who cannot join
- Currently pregnant or breast-feeding.
- Currently has any clinically detectable abnormality on the vulva, vaginal walls or cervix.
- Currently has laboratory confirmed gonorrhea, chlamydia, trichomonas or syphilis, has Genital Ulcer Disease (GUD) or vaginal candidiasis symptoms; or has an HSV-2 lesion as indicated by clinical diagnosis or laboratory test.
- Symptomatic bacterial vaginosis (BV) and unwilling to undergo treatment.
- Current use of injection drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel in Healthy HIV-Negative Women.
Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy HIV-negative women ages 18 to 50. Volunteers will be randomized in a 1:1:1 ratio to receive 2.5mL dapivirine vaginal microbicide gel at one of three concentrations.
- Conditions
- HIV Infections
- Being tested
- dapivirine (TMC120) vaginal gel
- 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.
dapivirine (TMC120) vaginal gelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess plasma levels and pharmacokinetics of dapivirine applied vaginally. To measure vaginal fluid and vaginal tissue levels of dapivirine at various time after application of the gel.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study startNov 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Zeda Rosenberg, ScD, Study director, Beijing Immupeutics Medicine Technology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304642
- Sponsor's protocol ID
- IPM004
- Status last verified
- Jun 2006
- First submitted
- 16 Mar 2006
- Last updated
- 2 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Pharmacokinetics of Dapivirine (TMC120) Vaginal Microbicide Gel in Healthy HIV-Negative Women.
- ClinicalTrials.gov ID
- NCT00304642
- Acronym / sponsor ID
- IPM004
- Conditions
- HIV Infections
- Keywords
- HIV-1, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2005
- First posted
- 20 Mar 2006 (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.
Approximately 18 women will be enrolled in this single-center, double-blind, randomized Phase I study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of dapivirine (TMC120) gel, which will be applied for 10 consecutive days in 18 healthy HIV-negative women ages 18 to 50. Volunteers will be randomized in a 1:1:1 ratio to receive 2.5mL dapivirine vaginal microbicide gel at one of three concentrations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- HIV-negative
- Willing to participate and sign and informed consent form.
- Willing to be tested for HIV and to use an experimental vaginal gel.
- Willing to use a reliable form of contraception during the study.
- Willing to undergo pelvic examinations with colposcopy according to the protocol throughout the study.
Key exclusion criteria (5 listed)
- Currently pregnant or breast-feeding.
- Currently has any clinically detectable abnormality on the vulva, vaginal walls or cervix.
- Currently has laboratory confirmed gonorrhea, chlamydia, trichomonas or syphilis, has Genital Ulcer Disease (GUD) or vaginal candidiasis symptoms; or has an HSV-2 lesion as indicated by clinical diagnosis or laboratory test.
- Symptomatic bacterial vaginosis (BV) and unwilling to undergo treatment.
- Current use of injection drugs.
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 (TMC120) vaginal gel | Drug | – |
Primary outcome
To assess plasma levels and pharmacokinetics of dapivirine applied vaginally. To measure vaginal fluid and vaginal tissue levels of dapivirine at various time after application of the gel.
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 2 Jun 2006.
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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.
Zeda Rosenberg, ScD study director
Beijing Immupeutics Medicine Technology Limited
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 (TMC120) vaginal gel in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 1 site in South Africa.
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 5 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 2 Jun 2006. 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 South Africa. 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?
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?
To assess plasma levels and pharmacokinetics of dapivirine applied vaginally. To measure vaginal fluid and vaginal tissue levels of dapivirine at various time after application of the gel.. 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 2 Jun 2006.