HIV InfectionsPhase 1NCT02920827
Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From a Vaginal Ring
A Phase 1 study testing Dapivirine Vaginal Ring 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 placebo-controlled trial to assess the safety and tolerability of the dapivirine ring as compared to a placebo ring when inserted for 28 days in 16 healthy, HIV-negative 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 Vaginal Ring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2009to Apr 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
- were females between 18 and 40 years of age, inclusive
- were willing and able to give written, informed consent
- were available for all visits and consented to follow all procedures scheduled for the trial
- were healthy, based on medical history, vital signs, physical examination, urinalysis (dipstick and microscopy), laboratory evaluations for genital infections (gonorrhea, chlamydia and trichomonas), and laboratory evaluations for hematology and biochemistry
- were HIV-negative, as determined by an HIV test at screening
- were willing to abstain from sexual activity for the duration of the period of ring use
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- were on a stable form of contraception, defined as a stable oral contraceptive regimen for at least two months prior to enrollment; OR a transdermal contraceptive patch for at least three months prior to enrollment; OR long-acting progestins for at least six months prior to enrollment; OR had an intra-uterine device (IUD) inserted (with no vaginal or gynecological complaints associated with its use) at least three months prior to enrollment; OR had undergone surgical sterilization at least three months prior to enrollment; AND were willing to use oral contraceptives, if necessary, to avoid menstruation while taking part in this trial
- were asymptomatic for genital infections at the time of enrollment, and the cervix and vagina appeared normal upon pelvic examination and colposcopy, as determined by the investigator
- were willing to refrain from the use of vaginal products or objects including, but not limited to, tampons, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method), douches, lubricants, vibrators/dildos, non-trial vaginal rings and drying agents for 14 days prior to enrollment and for the duration of the trial
- were willing to refrain from participation in any other research trial for the duration of this trial
- were willing to provide adequate locator information for trial retention purposes and were reachable per local standard procedures (e.g. by home visit or telephone, or via family or close neighbor contacts (confidentiality was to be maintained))
- were hepatitis B and C negative at the time of screening.
Who cannot join
- had a history of anaphylaxis or severe allergy resulting in angioedema, or a history of sensitivity/allergy to latex or silicone
- were pregnant or breast-feeding, or had their last pregnancy outcome within three months prior to screening
- were participating in any other clinical research trial involving investigational or marketed products at the time of this trial or within two months prior to screening
- had a history or diagnosis of and/or treatment for a sexually transmitted disease within the previous three months
- had a history of genital tract surgery within the previous two months
- had a current diagnosis of sexually transmitted infections (STIs) (gonorrhea, chlamydia and/or trichomonas)
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- had current vulvar or vaginal symptoms/abnormalities that could influence the trial results
- had a history of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction, incontinence or urge incontinence
- had symptomatic genital herpes simplex virus (HSV) infection or a history of genital herpetic infection
- had current non-iatrogenic pelvic/colposcopic examination findings involving deep epithelial disruption
- had any Grade 2, 3 or 4 hematology, biochemistry or urinalysis laboratory abnormality at baseline (screening), according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Adverse Events
- had a Pap test result at screening that required cryotherapy, biopsy, treatment (other than for infection) or further evaluation; this included any findings of atypical squamous cells of undetermined significance (ASCUS)
- had any condition(s) that, in the opinion of the investigator, could 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 Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess Delivery of Dapivirine From the Matrix Vaginal Ring Containing 25 MG of Dapivirine
The proposed study is a single center, double-blind placebo-controlled trial to assess the safety and tolerability of the dapivirine ring as compared to a placebo ring when inserted for 28 days in 16 healthy, HIV-negative women.
Read the detailed description
The objective of this trial was to evaluate the feasibility of using a platinum-catalyzed matrix vaginal ring, containing 25 mg of dapivirine, to deliver investigational product for 28 continuous days. The specific objectives were to:
- Assess the safety and tolerability of the vaginal ring containing dapivirine, when used continuously for 28 days, compared to a placebo ring
- Assess dapivirine concentrations in plasma before, during and after 28 days' use of a silicone elastomer matrix vaginal ring containing dapivirine
- Assess dapivirine concentrations in vaginal fluids before, during and after 28 days' use of a silicone elastomer matrix vaginal ring containing dapivirine. Safety was evaluated from clinical evaluations, clinical laboratory test results and adverse events (AEs). The pharmacokinetic (PK) evaluation was made based on systemic absorption from plasma concentrations and local disposition from vaginal fluid concentrations.
- Conditions
- HIV Infections
- Being tested
- Dapivirine Vaginal Ring, Placebo vaginal ring
- Keywords
- HIV Infections, 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 Vaginal RingCombination product
A platinum-catalysed silicone elastomer matrix vaginal ring containing 25mg of dapivirine used over 28 days
Placebo vaginal ringCombination product
Placebo vaginal ring containing no dapivirine
| Study group | Role | What they receive |
|---|---|---|
| Dapivirine Vaginal Ring | Experimental | Vaginal ring containing 25 mg dapivirine Receives: Combination Product: Dapivirine Vaginal Ring |
| Placebo Vaginal Ring | Placebo comparator | Placebo vaginal ring Receives: Combination Product: Placebo vaginal ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: To assess the safety and tolerability of the dapivirine vaginal ring, the endpoint was the proportion of women on the 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
- positive diagnostic tests for trichomonas, gonorrhea, and/or chlamydia
- at least one AE during the trial period
- any laboratory abnormalities on hematology and biochemistry
- abnormal vaginal pH and/or abnormal vaginal flora during the course of the trial.
Measured: 28 days
Pharmacokinetics: assessed by measurement of the concentrations of dapivirine in plasma and in vaginal fluids (collected by Tear Test Strips) before, during and after the trial period.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionApr 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annalene Nel, PhD, Study director, Beijing Immupeutics Medicine Technology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920827
- Sponsor's protocol ID
- IPM024
- Status last verified
- Sep 2017
- First submitted
- 29 Sep 2016
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomised, Placebo-Controlled Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess Delivery of Dapivirine From the Matrix Vaginal Ring Containing 25 MG of Dapivirine
- ClinicalTrials.gov ID
- NCT02920827
- Acronym / sponsor ID
- IPM024
- Conditions
- HIV Infections
- Keywords
- HIV Infections, HIV seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 30 Sep 2016 (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 placebo-controlled trial to assess the safety and tolerability of the dapivirine ring as compared to a placebo ring when inserted for 28 days in 16 healthy, HIV-negative women.
Detailed description
The objective of this trial was to evaluate the feasibility of using a platinum-catalyzed matrix vaginal ring, containing 25 mg of dapivirine, to deliver investigational product for 28 continuous days. The specific objectives were to:
- Assess the safety and tolerability of the vaginal ring containing dapivirine, when used continuously for 28 days, compared to a placebo ring
- Assess dapivirine concentrations in plasma before, during and after 28 days' use of a silicone elastomer matrix vaginal ring containing dapivirine
- Assess dapivirine concentrations in vaginal fluids before, during and after 28 days' use of a silicone elastomer matrix vaginal ring containing dapivirine. Safety was evaluated from clinical evaluations, clinical laboratory test results and adverse events (AEs). The pharmacokinetic (PK) evaluation was made based on systemic absorption from plasma concentrations and local disposition from vaginal fluid concentrations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapivirine Vaginal Ring | Experimental | Combination Product: Dapivirine Vaginal RingVaginal ring containing 25 mg dapivirine |
| Placebo Vaginal Ring | Placebo comparator | Combination Product: Placebo vaginal ringPlacebo vaginal ring |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- were females between 18 and 40 years of age, inclusive
- were willing and able to give written, informed consent
- were available for all visits and consented to follow all procedures scheduled for the trial
- were healthy, based on medical history, vital signs, physical examination, urinalysis (dipstick and microscopy), laboratory evaluations for genital infections (gonorrhea, chlamydia and trichomonas), and laboratory evaluations for hematology and biochemistry
- were HIV-negative, as determined by an HIV test at screening
Key exclusion criteria (13 listed)
- had a history of anaphylaxis or severe allergy resulting in angioedema, or a history of sensitivity/allergy to latex or silicone
- were pregnant or breast-feeding, or had their last pregnancy outcome within three months prior to screening
- were participating in any other clinical research trial involving investigational or marketed products at the time of this trial or within two months prior to screening
- had a history or diagnosis of and/or treatment for a sexually transmitted disease within the previous three months
- had a history of genital tract surgery within the previous two 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 Vaginal RingA platinum-catalysed silicone elastomer matrix vaginal ring containing 25mg of dapivirine used over 28 days | Combination product | Dapivirine Vaginal Ring |
| Placebo vaginal ringPlacebo vaginal ring containing no dapivirine | Combination product | Placebo Vaginal Ring |
Primary outcome
Safety: To assess the safety and tolerability of the dapivirine vaginal ring, the endpoint was the proportion of women on the dapivirine or placebo ring experiencing specific, protocol-defined safety events during the study (see description).
Time frame: 28 days
* mucosal abnormalities (as defined in the CONRAD/WHO manual) visible during naked eye examination and/or colposcopy * positive diagnostic tests for trichomonas, gonorrhea, and/or chlamydia * at least one AE during the trial period * any laboratory abnormalities on hematology and biochemistry * abnormal vaginal pH and/or abnormal vaginal flora during the course of the trial.
Pharmacokinetics: assessed by measurement of the concentrations of dapivirine in plasma and in vaginal fluids (collected by Tear Test Strips) before, during and after the trial period.
Time frame: 28 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 8 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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.
Annalene 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 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 12 inclusion and 13 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 8 Sep 2017. 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 and tolerability of the dapivirine vaginal ring, the endpoint was the proportion of women on the dapivirine or placebo ring experiencing specific, protocol-defined safety events during the study (see description). (time frame: 28 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 8 Sep 2017.