HIV InfectionsPhase 1/2NCT00303576
A Safety and Tolerability Study of Dapivirine (TMC120) Vaginal Microbicide Gel
A Phase 1/2 study testing dapivirine (TMC120) vaginal gel in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 4 sites in 3 countries.
Trial summary
Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or matching placebo gel. The volunteers will receive investigational product for a total of 42 days. 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
- 112 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Oct 2005to Jul 2006
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV-negative
- Willing to participate and sign an informed consent
- Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
- Willing to use two forms of contraception during the study.
- Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
- Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses.
- Willing to abstain from using any vaginal product (other than the study product or placebo).
- Willing to be sexually abstinent from randomization until completion of Day 7 evaluations.
Who cannot join
- Currently pregnant or breast-feeding.
- Clinically detectable genital abnormality on the vulva, vaginal walls or cervix.
- Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed genital ulcer disease or active HSV-2 lesions.
- Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization.
- Symptomatic bacterial vaginosis and unwilling to undergo treatment.
- Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
South Africa2 sites
Farmovs-Parexel
Bloemfontein
Reproductive Health Research Unit - Sheshisani IPM Clinic
Yeoville, Johannesburg
About this study
Official title: A Phase I/II Double-Blind, Randomized Study of the Safety, Tolerability and Systemic Absorption of TMC120 Vaginal Microbicide Gel and Matching Placebo in Healthy HIV-Negative Women.
Approximately 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or matching placebo gel. The volunteers will receive investigational product for a total of 42 days. Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and compliance.
- 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.
Local and systemic safety and tolerability.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startOct 2005
- Study completionJul 2006
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 112 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
- NCT00303576
- Sponsor's protocol ID
- IPM003
- Status last verified
- Jul 2006
- First submitted
- 15 Mar 2006
- Last updated
- 31 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Double-Blind, Randomized Study of the Safety, Tolerability and Systemic Absorption of TMC120 Vaginal Microbicide Gel and Matching Placebo in Healthy HIV-Negative Women.
- ClinicalTrials.gov ID
- NCT00303576
- Acronym / sponsor ID
- IPM003
- Conditions
- HIV Infections
- Keywords
- HIV-1, HIV Seronegativity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Jul 2006
- First posted
- 17 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 112 HIV-negative women, aged 18 to 50, will be enrolled in this multicenter study at four sites. Volunteers will be randomized to dapivirine (TMC120) vaginal gel or matching placebo gel. The volunteers will receive investigational product for a total of 42 days. Volunteers will be monitored on days 7, 28 and 42 for safety, tolerability and compliance.
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 an informed consent
- Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
- Willing to use two forms of contraception during the study.
- Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
Key exclusion criteria (6 listed)
- Currently pregnant or breast-feeding.
- Clinically detectable genital abnormality on the vulva, vaginal walls or cervix.
- Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed genital ulcer disease or active HSV-2 lesions.
- Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization.
- Symptomatic bacterial vaginosis and unwilling to undergo treatment.
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
Local and systemic safety and tolerability.
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 31 Jul 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
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing dapivirine (TMC120) vaginal gel in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 4 sites in 3 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 8 inclusion and 6 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 31 Jul 2006. 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, Rwanda, 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 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?
Local and systemic safety and tolerability.. 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 31 Jul 2006.