HIV InfectionsPhase 1NCT01144676
A Safety Study to Assess the Delivery of Dapivirine From a Matrix Vaginal Ring
A Phase 1 study testing dapivirine in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 1 site in Belgium.
Trial summary
The proposed study is a single-center, double-blind, randomised, placebo-controlled trial to evaluate the delivery of dapivirine from matrix vaginal rings over a 56 and 57 day period and to assess the safety as compared to placebo vaginal rings in 48 healthy, HIV-negative, sexually active women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- dapivirine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2010to Sep 2010
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women ≥18 and ≤40 years of age who can give written informed consent;
- Available for all visits and consent to follow all procedures scheduled for the trial;
- Healthy and self-reported sexually active (defined as an average of one penetrative penile vaginal coital act per month for the 3 months prior to enrolment);
- Be on a stable form of contraception, defined as:
- A stable oral contraceptive regimen for at least 2 months prior to enrolment, OR,
- Transdermal contraceptive patch for at least 3 months prior to enrolment, OR,
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- Long-acting progestins for at least 6 months prior to enrolment, OR,
- An IUD inserted (with no vaginal or gynaecological complaints associated with its use) at least 3 months prior to enrolment, OR,
- Have undergone surgical sterilization at least 3 months prior to enrolment;
- In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle, defined as having a minimum of 21 days and a maximum of 35 days between menses;
- Upon pelvic examination and colposcopy at the time of enrolment, the cervix and vagina appear normal as determined by the Investigator;
- Asymptomatic for genital infections at the time of enrolment (if a woman is diagnosed with any treatable STI, either syndromically or by laboratory test at the time of screening, she must receive treatment at least 2 weeks prior to enrolment);
- Willing to refrain from the use of vaginal products or objects including, female condoms, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method), douches, lubricants, vibrators/dildos, and drying agents for 14 days prior to enrolment and for the duration of the trial. Tampon use will be permitted;
- Willing to use oral contraceptives to avoid menstruation, if necessary while taking part in this trial;
- Documentation of no abnormality on Pap test, including grossly bloody smear, within 90 days prior to screening;
- Willing to refrain from participation in any other research trial for the duration of this trial;
- Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures [e.g., by home visit or telephone; or via family or close neighbour contacts (confidentiality to be maintained)];
- Willing to agree to abstain from all the following criteria for a total of 2 days (48 hours) prior to each trial visit, as well as for a total of 3 days (72 hours) after the biopsy procedure:
- Vaginal intercourse
- Oral contact with her genitalia
- Hepatitis B and C negative at the time of enrolment.
Who cannot join
- Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening;
- Currently breast-feeding;
- Currently or within two months of participation in any other clinical research trial involving investigational or marketed products prior to screening;
- Untreated symptomatic urogenital infections, e.g., urinary tract or other sexually transmitted infections, or other gynaecological conditions such as vaginal itching, pain, or discharge, within 2 weeks prior to enrolment;
- Presence of any abnormal clinically significant physical finding on the vulva, vaginal walls or cervix during pelvic examination and/or colposcopy at pre-enrolment;
- History of urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence or urge incontinence;
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- Current vulvar or vaginal symptoms / abnormalities that could influence the trial results;
- Pap test result that requires cryotherapy, biopsy, treatment (other than for infection); or further evaluation [this includes any findings of atypical squamous cells of undetermined significance (ASCUS)];
- Symptomatic genital HSV infection or a history of genital herpetic infection;
- Any Grade 2, 3 or 4 haematology, chemistry or urinalysis laboratory abnormality at baseline (screening) according to the DAIDS Table for Grading Adverse Events (NOTE: This table can be found at: http://rcc.tech-res.com/safetyandpharmacovigilance;and a standardized version will be provided to the research centre in the Study Operations Manual);
- Unexplained, abnormal bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrolment;
- Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or silicone;
- Any serious acute, chronic or progressive disease (e.g., any known history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV, AIDS, or blood dyscrasias), or signs of cardiac disease, renal failure, or severe malnutrition;
- Have undergone a hysterectomy;
- Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomised, Placebo-Controlled Pharmacokinetic and Safety Trial in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From a Matrix Vaginal Ring and to Evaluate the Safety of a Matrix Vaginal Ring Containing 25 MG of Dapivirine
The proposed study is a single-center, double-blind, randomised, placebo-controlled trial to evaluate the delivery of dapivirine from matrix vaginal rings over a 56 and 57 day period and to assess the safety as compared to placebo vaginal rings in 48 healthy, HIV-negative, sexually active women.
- Conditions
- HIV Infections
- Being tested
- dapivirine, placebo
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapivirineDrug
25mg dapivirine per ring.
The first vaginal ring will be removed on Day 28, and a new vaginal ring will be reinserted after 3 days, on day 31, for another 28 days.
placeboDrug
The first vaginal ring will be removed on Day 28, and a new vaginal ring will be reinserted after 3 days, on day 31, for another 28 days.
dapivirineDrug
25mg dapivirine per ring.
The first vaginal ring will be removed on day 35 and the new vaginal ring will be reinserted after 3 days, on day 38, for another 21 days. A third vaginal ring will be inserted immediately following removal of second ring on Day 59 and will be worn for 24 hours.
placeboDrug
The first vaginal ring will be removed on day 35 and the new vaginal ring will be reinserted after 3 days, on day 38, for another 21 days. A third vaginal ring will be inserted immediately following removal of second ring on Day 59 and will be worn for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group A1: Dapivirine Vaginal Ring | Experimental | Not described Receives: Drug: dapivirine |
| Group A2: Placebo Vaginal Ring | Placebo comparator | Not described Receives: Drug: placebo |
| Group B1: Dapivirine Vaginal Ring | Experimental | Not described Receives: Drug: dapivirine |
| Group B2: Placebo Vaginal Ring | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: To assess the safety of the dapivirine vaginal ring, the endpoint was the proportion of women in four vaginal ring regimens on dapivirine or placebo ring experiencing specific, protocol-defined safety events during the study (see description)
- Mucosal abnormalities (as defined in the CONRAD/WHO manual) visible during naked eye examination and/or colposcopy;
- Abnormal vaginal pH and/or abnormal vaginal flora during the course of the trial.
- Positive diagnostic tests for trichomonas, gonorrhoea and/or chlamydia;
- At least one adverse event during the 12-week trial period;
- Any laboratory abnormalities on haematology, electrolytes, liver function, and renal function.
Measured: 56/57 days
Pharmacokinetics: To examine local and systemic pharmacokinetics of dapivirine concentrations delivered by the vaginal rings, measured in plasma, vaginal fluids and cervical tissue during the trial period
Measured: 56/57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionSep 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
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Annelene Nel, PhD, Study director, Beijing Immupeutics Medicine Technology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144676
- Sponsor's protocol ID
- IPM 013
- Status last verified
- Oct 2010
- First submitted
- 10 Jun 2010
- Last updated
- 6 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomised, Placebo-Controlled Pharmacokinetic and Safety Trial in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From a Matrix Vaginal Ring and to Evaluate the Safety of a Matrix Vaginal Ring Containing 25 MG of Dapivirine
- ClinicalTrials.gov ID
- NCT01144676
- Acronym / sponsor ID
- IPM 013
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Jun 2010 (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 single-center, double-blind, randomised, placebo-controlled trial to evaluate the delivery of dapivirine from matrix vaginal rings over a 56 and 57 day period and to assess the safety as compared to placebo vaginal rings in 48 healthy, HIV-negative, sexually active women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A1: Dapivirine Vaginal Ring | Experimental | Drug: dapivirine |
| Group A2: Placebo Vaginal Ring | Placebo comparator | Drug: placebo |
| Group B1: Dapivirine Vaginal Ring | Experimental | Drug: dapivirine |
| Group B2: Placebo Vaginal Ring | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Women ≥18 and ≤40 years of age who can give written informed consent;
- Available for all visits and consent to follow all procedures scheduled for the trial;
- Healthy and self-reported sexually active (defined as an average of one penetrative penile vaginal coital act per month for the 3 months prior to enrolment);
- Be on a stable form of contraception, defined as:
- In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle, defined as having a minimum of 21 days and a maximum of 35 days between menses;
Key exclusion criteria (15 listed)
- Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening;
- Currently breast-feeding;
- Currently or within two months of participation in any other clinical research trial involving investigational or marketed products prior to screening;
- Untreated symptomatic urogenital infections, e.g., urinary tract or other sexually transmitted infections, or other gynaecological conditions such as vaginal itching, pain, or discharge, within 2 weeks prior to enrolment;
- Presence of any abnormal clinically significant physical finding on the vulva, vaginal walls or cervix during pelvic examination and/or colposcopy at pre-enrolment;
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 |
|---|---|---|
| dapivirine25mg dapivirine per ring. The first vaginal ring will be removed on Day 28, and a new vaginal ring will be reinserted after 3 days, on day 31, for another 28 days. | Drug | Group A1: Dapivirine Vaginal Ring |
| placeboThe first vaginal ring will be removed on Day 28, and a new vaginal ring will be reinserted after 3 days, on day 31, for another 28 days. | Drug | Group A2: Placebo Vaginal Ring |
| dapivirine25mg dapivirine per ring. The first vaginal ring will be removed on day 35 and the new vaginal ring will be reinserted after 3 days, on day 38, for another 21 days. A third vaginal ring will be inserted immediately following removal of second ring on Day 59 and will be worn for 24 hours. | Drug | Group B1: Dapivirine Vaginal Ring |
| placeboThe first vaginal ring will be removed on day 35 and the new vaginal ring will be reinserted after 3 days, on day 38, for another 21 days. A third vaginal ring will be inserted immediately following removal of second ring on Day 59 and will be worn for 24 hours. | Drug | Group B2: Placebo Vaginal Ring |
Primary outcome
Safety: To assess the safety of the dapivirine vaginal ring, the endpoint was the proportion of women in four vaginal ring regimens on dapivirine or placebo ring experiencing specific, protocol-defined safety events during the study (see description)
Time frame: 56/57 days
* Mucosal abnormalities (as defined in the CONRAD/WHO manual) visible during naked eye examination and/or colposcopy; * Abnormal vaginal pH and/or abnormal vaginal flora during the course of the trial. * Positive diagnostic tests for trichomonas, gonorrhoea and/or chlamydia; * At least one adverse event during the 12-week trial period; * Any laboratory abnormalities on haematology, electrolytes, liver function, and renal function.
Pharmacokinetics: To examine local and systemic pharmacokinetics of dapivirine concentrations delivered by the vaginal rings, measured in plasma, vaginal fluids and cervical tissue during the trial period
Time frame: 56/57 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 6 Oct 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.
Annelene Nel, PhD 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 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 21 inclusion and 15 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 6 Oct 2010. 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: To assess the safety of the dapivirine vaginal ring, the endpoint was the proportion of women in four vaginal ring regimens on dapivirine or placebo ring experiencing specific, protocol-defined safety events during the study (see description) (time frame: 56/57 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 6 Oct 2010.