Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women
Study Details
Study Description
Brief Summary
This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Vaginal Ring Vaginal Ring containing 0.0 mg Dapivirine |
Combination Product: Placebo Vaginal Ring
Dapivirine Vaginal Ring containing 0.0 mg of 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
|
Outcome Measures
Primary Outcome Measures
- 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. [24 months]
Rapid and specialised laboratory testing according to the comprehensive HIV testing algorithm.
- All adverse events [24 months]
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.
Secondary Outcome Measures
- The incidence rate of HIV-2 seroconversion; [24 months]
Rapid and specialised laboratory testing.
- The incidence of curable STIs [24 months]
STI testing, vaginal flora and vaginal pH testing
- The incidence of pregnancy in each trial arm over the IP use period; [24 months]
Pregnancy testing
- The proportion of women who report adherence to the use of the vaginal ring inserted once every 4 weeks over the trial period; [24 months]
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
- The proportion of women who report the use of the vaginal ring as acceptable; [24 months]
Questionnaires and qualitative data regarding the acceptability of use of a vaginal ring inserted once every 4 weeks over the trial period;
- The proportion of participants with HIV-1 drug resistance mutations among participants who acquire HIV-1. [24 months]
Viral genotyping methods
Eligibility Criteria
Criteria
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;
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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);
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HIV-negative as determined by the HIV algorithm applied at screening and enrolment;
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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;
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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);
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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;
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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:
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Currently pregnant or last pregnancy within 3 months prior to screening or intends to become pregnant during trial participation;
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Currently breast-feeding;
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Non-therapeutic injection drug use in the 12 months prior to screening;
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Participated in another research trial using drugs, medical devices, microbicides or oral pre-exposure prophylaxis agents within 60 days prior to screening;
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Previously participated or currently participating in any HIV vaccine trial;
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Untreated, clinically significant urogenital infections , e.g., urinary tract, or other sexually transmitted infections, or other gynaecological symptoms within 1 week prior to enrolment;
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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;
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History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, diagnosed chronic and/or recurrent vulvovaginal candidiasis, urethral obstruction, incontinence or urge incontinence;
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Any gynaecological surgery within 90 days prior to screening;
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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;
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Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or a silicone elastomer;
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Any history of diabetes mellitus and chronic use of oral corticosteroid therapy; and any uncontrolled serious chronic or progressive disease;
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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);
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qhakaza Mbokodo | Ladysmith | Kwazulu Natal | South Africa | |
| 2 | Prevention of HIV / AIDS (PHIVA) Project | Pinetown | KwaZulu Natal | South Africa | 3610 |
| 3 | Ndlovu Medical Centre | Elandsdoorn | Limpopo | South Africa | 0485 |
| 4 | Madibeng Centre for Research (MCR) | Brits | South Africa | 0250 | |
| 5 | Desmond Tutu HIV Foundation, Guinea Fowl Road, Sunnydale, Fish Hoek | Cape Town | South Africa | 7975 | |
| 6 | Maternal, Adolescent and Child Health (MatCH) | Plessislaer | South Africa | 3216 | |
| 7 | MRC/UVRI Uganda Research Unit on AIDS, Plot 51-59, Nakiwogo Road, PO BOX 49 | Masaka | Uganda |
Sponsors and Collaborators
- International Partnership for Microbicides, Inc.
Investigators
- Study Director: Annalene Nel, IPM
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IPM 027