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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by International Partnership for Microbicides, Inc.
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT01539226
First received: February 21, 2012
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.


Condition Intervention Phase
HIV Infections
Drug: Dapivirine
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:
  • Efficacy as determined by the proportion of women in each arm with HIV-1 seroconversion rate per person-years of product use [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

  • Safety as determined by all AEs reported, regardless of grade or relatedness (based on DAIDS grading) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    This will be measured by self-reports, physical examination, gynaecological assessments, including pelvic/speculum examination, laboratory tests and other indicated investigations.


Estimated Enrollment: 1650
Study Start Date: March 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Vaginal ring containing no drug substance
Other: Placebo
Vaginal ring containing no drug substance
Experimental: Dapivirine
Vaginal ring containing 25mg of dapivirine
Drug: Dapivirine
Vaginal ring containing 25mg dapivirine; one ring inserted once every 4 weeks over 24 months

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539226

Contacts
Contact: Annalene Nel anel@ipmglobal.org

Locations
Rwanda
Project Ubuzima Not yet recruiting
Kiyivu, Kigali, Rwanda
Contact: Gilles F Ndayisaba    +250(0)788406070    ndayisaba@gmail.com   
Principal Investigator: Gilles F Ndayisaba         
South Africa
Qhakaza Mbokodo Recruiting
Ladysmith, Kwazulu Natal, South Africa
Principal Investigator: Dr Phillip Kotze         
Prevention of HIV / AIDS (PHIVA) Project Recruiting
Pinetown, KwaZulu Natal, South Africa, 3610
Contact       mterblanche@ipmglobal.org   
Principal Investigator: Derek Arbuckle, PhD         
Madibeng Centre for Research (MCR) Recruiting
Brits, South Africa, 0250
Principal Investigator: Cheryl Louw, PhD         
Maternal, Adolescent and Child Health (MatCH) Recruiting
Plessislaer, South Africa, 3216
Principal Investigator: Cynthia Gama, PhD         
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Director: Annalene Nel IPM
  More Information

No publications provided

Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT01539226     History of Changes
Other Study ID Numbers: IPM 027
Study First Received: February 21, 2012
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council

Keywords provided by International Partnership for Microbicides, Inc.:
HIV Infections
Anti-HIV agents
HIV-1

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 28, 2014