HIV InfectionsPhase 3NCT01337583
A Safety and Efficacy Trial of Dapivirine Vaginal Ring in Africa
A Phase 3 study testing Dapivirine in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 5 sites in 3 countries.
Trial summary
This is a double-blind, randomized, placebo-controlled Phase III study to asses the safety and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine. 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
- 0 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jul 2011to Jul 2014
- Phase
- Phase 3
- 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 provide informed consent
- Available for all visits and consent to follow all procedures scheduled for the trial
- Generally healthy and self-reported sexually active (defined as an average of at least one penetrative penile vaginal coital act per month for the last 3 months prior to enrolment)
- HIV-negative as determined by the HIV algorithm applied at screening and enrolment
- On a stable form of contraception and willing to continue on stable contraception for the duration of the clinical trial;
- Asymptomatic for genital infections at the time of enrolment (if a woman is diagnosed with any clinically significant treatable STI, she must have initiated treatment at least 1 week prior to enrolment and have completed the full course of treatment)
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- Willing to answer questions about adherence, sexual behaviour, vaginal practices and ring acceptability;
- 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 refrain from participation in another research trial using drugs, vaccines, medical devices, microbicides or oral pre-exposure prophylaxis investigational drugs for the duration of the IPM 009B trial;
- 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;
- Willing to refrain from use of vaginal products or objects including spermicides, tampons, female condoms, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method), douches and drying agents within 14 days from enrolment and for the duration of the trial.
Who cannot join
- Currently pregnant or last pregnancy within 3 months prior to screening;
- Currently breast-feeding
- Participated in another research trial using drugs, medical devices, microbicides or oral pre-exposure prophylaxis agents within 60 days prior to screening
- Previously participated or currently participating in any HIV vaccine trial
- Untreated, clinically significant urogenital infections (either symptomatic or asymptomatic), e.g., urinary tract or other sexually transmitted infections, or other gynaecological symptoms within 1 week prior to enrolment
- History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence or urge incontinence
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- Any gynaecological surgery within 90 days prior to enrolment
- Any Grade 3 or 4 baseline haematology, chemistry or urinalysis laboratory value according to the DAIDS Table for Grading Adverse Experiences, or clinically significant Grade 2 findings
- Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or a silicone elastomer
- Any history of diabetes mellitus and chronic use of oral steroid therapy and any uncontrolled serious chronic or progressive disease
- Cervical cytology at screening that requires cryotherapy, biopsy, treatment (other than for infection), or further evaluation [this includes any findings of atypical squamous cells of undetermined significance (ASCUS)]
- Any condition(s) that, in the opinion of the investigator, might put the participant at risk, or interfere with the trial objectives, or adherence to trial requirements
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
South Africa3 sites
Desmond Tutu HIV Foundation, Nyanga (DTHF)
Nyanga, Cape Town
Prevention of HIV / AIDS (PHIVA) Project
Pinetown, KwaZulu-Natal, 3610
Maternal, Adolescent and Child Health (MatCH)
Plessislaer, 3216
About this study
Official title: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Phase III Safety and Efficacy Trial of a Vaginal Matrix Ring With Dapivirine for the Prevention of HIV-1 Infection in Women
This is a double-blind, randomized, placebo-controlled Phase III study to asses the safety and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.
- Conditions
- HIV Infections
- Being tested
- Dapivirine, Placebo
- Keywords
- HIV Infections, Anti-HIV agents, HIV-1
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapivirineOther
Vaginal ring containing 25mg dapivirine; one ring inserted every 28 days for at least 15 months
PlaceboOther
Vaginal Ring containing no drug substance
DapivirineDrug
| Study group | Role | What they receive |
|---|---|---|
| Dapivirine | Experimental | Vaginal ring containing 25mg of dapivirine Receives: Other: Dapivirine; Drug: Dapivirine |
| Placebo Ring | Placebo comparator | Vaginal ring containing no drug substance Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as determined by HIV-1 seroconversion rate per person-years of product use, measured at the end of the investigational product use period.
The primary endpoint is HIV-1 seroconversion measured by rapid and specialized laboratory tests according to a comprehensive HIV testing algorithm. This algorithm employs a series of high specificity and high sensitivity immunoassay-based HIV blood tests that minimize the chance of false positive results to determine if a subject is positive for HIV. Endpoint confirmation of HIV infection is by Western blot.
Measured: 15 months
Safety as determined by grade 3 and 4 AE's, clinically significant grade 2 laboratory findings (based on DAIDS grading) and all serious AE's.
This will be measured by self-reports, physical examination, safety laboratory tests and other specialised investigations.
Measured: 15 months
Secondary outcomes (2)
Adherence to the protocol-specific product regimen as determined by self-reported diary cards and questionnaires.
Measured: 15 months
The incidence of curable STI's or pregnancy as determined by STI testing and pregnancy testing.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Annalene Nel, Study director, Beijing Immupeutics Medicine Technology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337583
- Sponsor's protocol ID
- IPM 009B
- Status last verified
- Jun 2012
- First submitted
- 13 Apr 2011
- Last updated
- 11 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Phase III Safety and Efficacy Trial of a Vaginal Matrix Ring With Dapivirine for the Prevention of HIV-1 Infection in Women
- ClinicalTrials.gov ID
- NCT01337583
- Acronym / sponsor ID
- IPM 009B
- Conditions
- HIV Infections
- Keywords
- HIV Infections, Anti-HIV agents, HIV-1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 19 Apr 2011 (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.
This is a double-blind, randomized, placebo-controlled Phase III study to asses the safety and efficacy of a silicone elastomer vaginal ring containing 25mg of dapivirine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapivirine | Experimental | Other: Dapivirine, Drug: DapivirineVaginal ring containing 25mg of dapivirine |
| Placebo Ring | Placebo comparator | Other: PlaceboVaginal ring containing no drug substance |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Women >18 and <40 years of age who can provide informed consent
- Available for all visits and consent to follow all procedures scheduled for the trial
- Generally healthy and self-reported sexually active (defined as an average of at least one penetrative penile vaginal coital act per month for the last 3 months prior to enrolment)
- HIV-negative as determined by the HIV algorithm applied at screening and enrolment
- On a stable form of contraception and willing to continue on stable contraception for the duration of the clinical trial;
Key exclusion criteria (12 listed)
- Currently pregnant or last pregnancy within 3 months prior to screening;
- Currently breast-feeding
- Participated in another research trial using drugs, medical devices, microbicides or oral pre-exposure prophylaxis agents within 60 days prior to screening
- Previously participated or currently participating in any HIV vaccine trial
- Untreated, clinically significant urogenital infections (either symptomatic or asymptomatic), e.g., urinary tract or other sexually transmitted infections, or other gynaecological symptoms within 1 week prior to 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 |
|---|---|---|
| DapivirineVaginal ring containing 25mg dapivirine; one ring inserted every 28 days for at least 15 months | Other | Dapivirine |
| PlaceboVaginal Ring containing no drug substance | Other | Placebo Ring |
| Dapivirine | Drug | Dapivirine |
Primary outcome
Efficacy as determined by HIV-1 seroconversion rate per person-years of product use, measured at the end of the investigational product use period.
Time frame: 15 months
The primary endpoint is HIV-1 seroconversion measured by rapid and specialized laboratory tests according to a comprehensive HIV testing algorithm. This algorithm employs a series of high specificity and high sensitivity immunoassay-based HIV blood tests that minimize the chance of false positive results to determine if a subject is positive for HIV. Endpoint confirmation of HIV infection is by Western blot.
Safety as determined by grade 3 and 4 AE's, clinically significant grade 2 laboratory findings (based on DAIDS grading) and all serious AE's.
Time frame: 15 months
This will be measured by self-reports, physical examination, safety laboratory tests and other specialised investigations.
2 secondary outcomes
Adherence to the protocol-specific product regimen as determined by self-reported diary cards and questionnaires.
Time frame: 15 months
The incidence of curable STI's or pregnancy as determined by STI testing and pregnancy testing.
Time frame: 15 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2012.
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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 study director
Beijing Immupeutics Medicine Technology Limited
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapivirine in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 5 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 11 inclusion and 12 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: withdrawn, as of the sponsor's last update on 11 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Africa, Kenya, Malawi. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Efficacy as determined by HIV-1 seroconversion rate per person-years of product use, measured at the end of the investigational product use period. (time frame: 15 months). 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 11 Jun 2012.