Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
HIV Infections	Combination Product: Placebo Vaginal Ring; Combination Product: Dapivirine Vaginal Ring, 25 mg	Not Applicable

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

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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

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. The incidence rate of HIV-2 seroconversion; [ Time Frame: 24 months ]

Eligibility Criteria

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

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;
• 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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

International Partnership for Microbicides, Inc.

Investigators

Study Director:	Annalene Nel	IPM

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
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