Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women
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ClinicalTrials.gov Identifier: NCT01539226 |
Recruitment Status
:
Completed
First Posted
: February 27, 2012
Last Update Posted
: March 16, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Combination Product: Placebo Vaginal Ring Combination Product: Dapivirine Vaginal Ring, 25 mg | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1950 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo Vaginal Ring
Vaginal Ring containing 0.0 mg Dapivirine
|
Combination Product: Placebo Vaginal Ring
Vaginal Ring containing 0.0 mg Dapivirine
|
Experimental: Dapivirine Vaginal Ring
Vaginal Ring containing 25mg of Dapivirine
|
Combination Product: Dapivirine Vaginal Ring, 25 mg
Dapivirine Vaginal Ring containing 25 mg of dapivirine
|
- Rapid and specialised laboratory testing according to the comprehensive HIV testing algorithm.Self-reports, physical examination, gynaecological assessments, including pelvic/speculum examination, laboratory tests and other indicated investigations. [ Time Frame: 24 months ]The primary endpoint is HIV-1 seroconversion as measured by rapid and specialised laboratory testing according to comprehensive HIV testing alorithm. Endpoint confirmation of HIV infection is by Western blot.
- The incidence rate of HIV-2 seroconversion; [ Time Frame: 24 months ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539226
South Africa | |
Qhakaza Mbokodo | |
Ladysmith, Kwazulu Natal, South Africa | |
Prevention of HIV / AIDS (PHIVA) Project | |
Pinetown, KwaZulu Natal, South Africa, 3610 | |
Madibeng Centre for Research (MCR) | |
Brits, South Africa, 0250 | |
Desmond Tutu HIV Foundation, Pokela Road, Masiphumelele, Fish Hoek | |
Cape Town, South Africa, 7975 | |
Ndlovu Medical Centre | |
Limpopo, South Africa | |
Maternal, Adolescent and Child Health (MatCH) | |
Plessislaer, South Africa, 3216 | |
Uganda | |
MRC/UVRI Uganda Research Unit on AIDS, Plot 51-59, Nakiwogo Road, PO BOX 49 | |
Entebbe, Uganda |
Study Director: | Annalene Nel | IPM |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | International Partnership for Microbicides, Inc. |
ClinicalTrials.gov Identifier: | NCT01539226 History of Changes |
Other Study ID Numbers: |
IPM 027 |
First Posted: | February 27, 2012 Key Record Dates |
Last Update Posted: | March 16, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by International Partnership for Microbicides, Inc.:
HIV Infections Anti-HIV agents HIV-1 |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |