HIV InfectionsPhase 1/2NCT01071174
A Safety Study of Dapivirine Vaginal Ring in Africa
A Phase 1/2 study testing Dapivirine in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 10 sites in 4 countries.
Trial summary
This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg 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
- 280 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Apr 2010to Jul 2011
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between 18 and 40 years of age inclusive who can provide informed consent
- Available for all visits and consent to follow all procedures scheduled for the study
- Healthy and self-reported sexually active
- HIV-negative
- On a stable form of contraception and willing to continue OR have undergone surgical sterilization at least 3 months prior to enrollment
- 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
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- Upon pelvic/speculum 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
- Willing to refrain from use of vaginal products or objects within 14 days from enrollment and for the duration of the study
- Willing to answer to acceptability, adherence and behavioural assessments throughout the study
- Willing to refrain from participation in any other research study for the duration of their participation
- Willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures
Who cannot join
- Currently pregnant or last pregnancy within 3 months prior to enrolment
- Currently breast-feeding
- Participated in any other research study within 60 days prior to screening
- Previously participated in any HIV vaccine study
- Untreated urogenital infections within 2 weeks prior to enrolment
- Presence of any abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy
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- History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, or urethral obstruction, incontinence or urge incontinence
- Pap smear result at screening that requires cryotherapy, biopsy, treatment or further evaluation
- Any Grade 2, 3 or 4 baseline (screening) haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Events
- Any abnormal bleeding per vagina, 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 elastomer
- Any serious acute, chronic or progressive disease
- Any condition(s) that, in the opinion of the investigator, might interfere with adherence to study requirements or evaluation of the study objectives
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
South Africa7 sites
Madibeng Centre for Research
Brits, North West
Desmond Tutu HIV Foundation Masiphumelele
Cape Town, Western Cape
Desmond Tutu HIV Foundation Nyanga
Cape Town, Western Cape
Reproductive Health and HIV Research Unit (RHRU)
Edendale, KwaZulu-Natal
Qhakaza Mbokodo
Ladysmith, KwaZulu-Natal
Be Part Yoluntu Centre Mbekweni
Paarl, Western Cape
Prevention for HIV and AIDS Project (PHIVA)
Pinetown, KwaZulu-Natal
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety of an Intravaginal Matrix Ring With Dapivirine in Healthy, HIV-Negative Women.
This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg 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 84 days (3 rings total)
PlaceboOther
Vaginal Ring containing no drug substance
| Study group | Role | What they receive |
|---|---|---|
| Placebo Ring | Placebo comparator | Vaginal Ring containing no drug substance Receives: Other: Placebo |
| Dapivirine Ring | Experimental | Dapivirine Vaginal Ring 25mg Receives: Other: Dapivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as determined by the proportion of women in each arm experiencing protocol-specified events, including AEs, laboratory abnormalities, cervico-vaginal abnormalities, abnormal vaginal flora/pH during the study.
Measured: 16 weeks
Secondary outcomes (2)
Acceptability of the product determined by questionnaire.
Measured: 16 weeks
Adherence to the protocol-specific product regimen as determined by self-report and clinician observation at each study visit.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr Annalene Nel, Study director, Beijing Immupeutics Medicine Technology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071174
- Sponsor's protocol ID
- IPM 015
- Status last verified
- Aug 2011
- First submitted
- 17 Feb 2010
- Last updated
- 2 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nel A, Bekker LG, Bukusi E, Hellstrӧm E, Kotze P, Louw C, Martinson F, Masenga G, Montgomery E, Ndaba N, van der Straten A, van Niekerk N, Woodsong C. Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa. PLoS One. 2016 Mar 10;11(3):e0147743. doi: 10.1371/journal.pone.0147743. eCollection 2016.
PubMed 26963505
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety of an Intravaginal Matrix Ring With Dapivirine in Healthy, HIV-Negative Women.
- ClinicalTrials.gov ID
- NCT01071174
- Acronym / sponsor ID
- IPM 015
- Conditions
- HIV Infections
- Keywords
- HIV infections, Anti-HIV agents, HIV-1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 Feb 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.
This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg dapivirine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Ring | Placebo comparator | Other: PlaceboVaginal Ring containing no drug substance |
| Dapivirine Ring | Experimental | Other: DapivirineDapivirine Vaginal Ring 25mg |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Women between 18 and 40 years of age inclusive who can provide informed consent
- Available for all visits and consent to follow all procedures scheduled for the study
- Healthy and self-reported sexually active
- HIV-negative
- On a stable form of contraception and willing to continue OR have undergone surgical sterilization at least 3 months prior to enrollment
Key exclusion criteria (13 listed)
- Currently pregnant or last pregnancy within 3 months prior to enrolment
- Currently breast-feeding
- Participated in any other research study within 60 days prior to screening
- Previously participated in any HIV vaccine study
- Untreated urogenital infections within 2 weeks 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 84 days (3 rings total) | Other | Dapivirine Ring |
| PlaceboVaginal Ring containing no drug substance | Other | Placebo Ring |
Primary outcome
Safety as determined by the proportion of women in each arm experiencing protocol-specified events, including AEs, laboratory abnormalities, cervico-vaginal abnormalities, abnormal vaginal flora/pH during the study.
Time frame: 16 weeks
2 secondary outcomes
Acceptability of the product determined by questionnaire.
Time frame: 16 weeks
Adherence to the protocol-specific product regimen as determined by self-report and clinician observation at each study visit.
Time frame: 12 weeks
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 Aug 2011.
- Derived from this study: PubMed 26963505Nel A, Bekker LG, Bukusi E, Hellstrӧm E, Kotze P, Louw C, Martinson F, Masenga G, Montgomery E, Ndaba N, van der Straten A, van Niekerk N, Woodsong C. Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa. PLoS One. 2016 Mar 10;11(3):e0147743. doi: 10.1371/journal.pone.0147743. eCollection 2016.
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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.
Dr Annalene Nel study director
Beijing Immupeutics Medicine Technology Limited
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dapivirine in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 10 sites in 4 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 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 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Africa, Kenya, Malawi, 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. 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 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?
Safety as determined by the proportion of women in each arm experiencing protocol-specified events, including AEs, laboratory abnormalities, cervico-vaginal abnormalities, abnormal vaginal flora/pH during the study. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01071174, which also lists 1 linked publication.
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 Aug 2011.