- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01539226
Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women
September 26, 2022 updated by: International Partnership for Microbicides, Inc.
A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women
This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A multi center, randomized, double-blind, placebo=controlled safety and efficacy trial of a Dapivirine Vaginal Matrix Ring in healthy HIV-negative women.
Study Type
Interventional
Enrollment (Actual)
1959
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brits, South Africa, 0250
- Madibeng Centre for Research (MCR)
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Cape Town, South Africa, 7975
- Desmond Tutu HIV Foundation, Guinea Fowl Road, Sunnydale, Fish Hoek
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Plessislaer, South Africa, 3216
- Maternal, Adolescent and Child Health (MatCH)
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KwaZulu Natal
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Pinetown, KwaZulu Natal, South Africa, 3610
- Prevention of HIV / AIDS (PHIVA) Project
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Kwazulu Natal
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Ladysmith, Kwazulu Natal, South Africa
- Qhakaza Mbokodo
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Limpopo
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Elandsdoorn, Limpopo, South Africa, 0485
- Ndlovu Medical Centre
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Masaka, Uganda
- MRC/UVRI Uganda Research Unit on AIDS, Plot 51-59, Nakiwogo Road, PO BOX 49
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women > 18 and < 45 years of age, at screening, who can provide informed consent;
- Available for all visits and consent to follow all procedures scheduled for the trial;
- 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 screening);
- HIV-negative as determined by the HIV algorithm applied at screening and enrolment;
- On a stable form of contraception as defined within section 5.4 and willing to continue on stable contraception for the duration of the clinical trial, unless post-menopausal or surgically sterilised;
- Asymptomatic for genital infections at the time of enrolment (if a woman is diagnosed with any clinically significant curable STI, she must have initiated treatment at least 1 week prior to enrolment and have completed the full course of treatment);
- 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 027 trial.
Exclusion Criteria:
- Currently pregnant or last pregnancy within 3 months prior to screening or intends to become pregnant during trial participation;
- Currently breast-feeding;
- Non-therapeutic injection drug use in the 12 months prior to screening;
- 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 , e.g., urinary tract, or other sexually transmitted infections, or other gynaecological symptoms within 1 week prior to enrolment;
- Has a Grade 2 or higher pelvic examination finding, according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events; Addendum 1 Female Genital Grading Table for Use in Microbicide Studies;
- History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, diagnosed chronic and/or recurrent vulvovaginal candidiasis, urethral obstruction, incontinence or urge incontinence;
- Any gynaecological surgery within 90 days prior to screening;
- Any Grade 1 or higher baseline aspartate aminotransferase (AST), alanine transaminase (ALT), or platelet count, and any Grade 2 or higher baseline haematology, chemistry or urinalysis laboratory value according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events;
- 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 corticosteroid therapy; and any uncontrolled serious chronic or progressive disease;
- Cervical cytology at screening that requires cryotherapy, biopsy or treatment (other than for infection). Women with Grade 1 cervical cytology findings can be enrolled upon completion of the initial phase of evaluation if no current treatment is indicated (based on local standard of care for management of abnormal cervical cytology);
- Any condition(s) that, in the opinion of the investigator, might put the participant at risk, or interfere with the trial objectives or the participant's adherence to trial requirements.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo Vaginal Ring
Vaginal Ring containing 0.0 mg Dapivirine
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Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
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Experimental: Dapivirine Vaginal Ring
Vaginal Ring containing 25mg of Dapivirine
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Dapivirine Vaginal Ring containing 25 mg of dapivirine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm.
Time Frame: 24 months
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HIV-1 seroconversion measured by rapid and specialised laboratory testing according to the comprehensive HIV testing algorithm.
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24 months
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All Adverse Events
Time Frame: 24 months
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Self-reports, physical examination, gynaecological assessments, including pelvic/speculum examination, laboratory tests and other indicated investigations.
All AEs will be reported, regardless of grade or relatedness.
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Incidence Rate of HIV-2 Seroconversion.
Time Frame: 24 months
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Rapid and specialised laboratory testing according to the comprehensive HIV testing algorithm in Appendix C of protocol.
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24 months
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The Incidence of Curable STIs
Time Frame: 24 months
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The percentage of participants testing positive for any STI (gonorrhoea, chlamydia, trichomonas, syphilis) will be assessed.
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24 months
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Percentage of Participants With Pregnancy in Each Trial Arm Over the IP Use Period;
Time Frame: 24 months
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The percentage of participants with pregnancies in each treatment group.
For each treatment group, the numerator will include the number of participants that had a positive urine pregnancy test during the trial period.
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24 months
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The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Time Frame: 24 months
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Questionnaires and qualitative data regarding sexual behaviour and adherence to the use of a vaginal ring inserted once every 4 weeks over the trial period. Dapivirine residual levels in used rings and dapivirine plasma concentrations are two objective measures of adherence to DVR ring use, |
24 months
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The Percentage of Women Who Report the Use of the Vaginal Ring as Acceptable;
Time Frame: 24 months
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Questionnaires and qualitative data regarding the acceptability of use of a vaginal ring inserted once every 4 weeks over the trial period; Number of participants with positive response.
Response of 'likely' or 'very likely' to the question: 'If in the future a vaginal ring was available that provided some protection against HIV, and it was similar to the one you used in this trial, how likely would you be to keep it inserted in your vagina every day?'
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24 months
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The Percentage of Participants With HIV-1 Drug Resistance Mutations Among Participants Who Acquire HIV-1.
Time Frame: 24 months
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The analysis of HIV-1 drug resistance will be primarily descriptive in nature, and will depend on the pattern of resistance mutations observed in the HIV-1 seroconverters.
The proportion of HIV-1 seroconverters with at least one HIV-1 drug resistant mutation will be presented overall, and by treatment arm, with corresponding 95% CIs.
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kusemererwa S, Abaasa A, Kabarambi A, Onyango M, Mugisha JO. Assessment of risk compensation following use of the dapivirine vaginal ring in southwestern Uganda. Sex Transm Infect. 2022 Feb;98(1):32-37. doi: 10.1136/sextrans-2020-054718. Epub 2021 Feb 4.
- Kusemererwa S, Abaasa A, Onyango M, Nel AM, Isaacs M, Asiki G. Contraceptive Preference Among Women at Risk of HIV Acquisition in a Preparatory Screening Study for a Phase III Microbicide Trial in South Western Uganda. AIDS Behav. 2018 Jul;22(Suppl 1):131-138. doi: 10.1007/s10461-018-2177-3.
- Nel A, van Niekerk N, Kapiga S, Bekker LG, Gama C, Gill K, Kamali A, Kotze P, Louw C, Mabude Z, Miti N, Kusemererwa S, Tempelman H, Carstens H, Devlin B, Isaacs M, Malherbe M, Mans W, Nuttall J, Russell M, Ntshele S, Smit M, Solai L, Spence P, Steytler J, Windle K, Borremans M, Resseler S, Van Roey J, Parys W, Vangeneugden T, Van Baelen B, Rosenberg Z; Ring Study Team. Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women. N Engl J Med. 2016 Dec 1;375(22):2133-2143. doi: 10.1056/NEJMoa1602046.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 27, 2012
Primary Completion (Actual)
December 13, 2016
Study Completion (Actual)
December 13, 2016
Study Registration Dates
First Submitted
February 21, 2012
First Submitted That Met QC Criteria
February 24, 2012
First Posted (Estimate)
February 27, 2012
Study Record Updates
Last Update Posted (Actual)
October 19, 2022
Last Update Submitted That Met QC Criteria
September 26, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Anti-Infective Agents
- Antiviral Agents
- Anti-HIV Agents
- Anti-Retroviral Agents
- Dapivirine
Other Study ID Numbers
- IPM 027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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