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A Safety Study of Dapivirine Vaginal Ring in Africa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01071174
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : August 2, 2011
Sponsor:
Information provided by:
International Partnership for Microbicides, Inc.

Tracking Information
First Submitted Date  ICMJE February 17, 2010
First Posted Date  ICMJE February 19, 2010
Last Update Posted Date August 2, 2011
Study Start Date  ICMJE April 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
Safety as determined by the proportion of women in each arm experiencing protocol-specified events, including AEs, laboratory abnormalities, cervico-vaginal abnormalities, abnormal vaginal flora/pH during the study. [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01071174 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2010)
  • Acceptability of the product determined by questionnaire. [ Time Frame: 16 weeks ]
  • Adherence to the protocol-specific product regimen as determined by self-report and clinician observation at each study visit. [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of Dapivirine Vaginal Ring in Africa
Official Title  ICMJE A Double-Blind, Randomized, Placebo-Controlled Phase I/II Study to Evaluate the Safety of an Intravaginal Matrix Ring With Dapivirine in Healthy, HIV-Negative Women.
Brief Summary This is a double-blind, randomized, placebo-controlled Phase I/II study to assess the safety of a silicone elastomer vaginal ring containing 25mg dapivirine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Other: Dapivirine
    Vaginal ring containing 25mg dapivirine; One ring inserted every 28 days for 84 days (3 rings total)
  • Other: Placebo
    Vaginal Ring containing no drug substance
Study Arms  ICMJE
  • Placebo Comparator: Placebo Ring
    Vaginal Ring containing no drug substance
    Intervention: Other: Placebo
  • Experimental: Dapivirine Ring
    Dapivirine Vaginal Ring 25mg
    Intervention: Other: Dapivirine
Publications * Nel A, Bekker LG, Bukusi E, Hellstrӧm E, Kotze P, Louw C, Martinson F, Masenga G, Montgomery E, Ndaba N, van der Straten A, van Niekerk N, Woodsong C. Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa. PLoS One. 2016 Mar 10;11(3):e0147743. doi: 10.1371/journal.pone.0147743. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2010)
280
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women between 18 and 40 years of age inclusive who can provide informed consent
  • Available for all visits and consent to follow all procedures scheduled for the study
  • Healthy and self-reported sexually active
  • HIV-negative
  • On a stable form of contraception and willing to continue OR have undergone surgical sterilization at least 3 months prior to enrollment
  • In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle defined as having a minimum of 21 days and a maximum of 35 days between menses
  • Upon pelvic/speculum examination and colposcopy at the time of enrolment, the cervix and vagina appear normal as determined by the investigator
  • Asymptomatic for genital infections at the time of enrolment
  • Willing to refrain from use of vaginal products or objects within 14 days from enrollment and for the duration of the study
  • Willing to answer to acceptability, adherence and behavioural assessments throughout the study
  • Willing to refrain from participation in any other research study for the duration of their participation
  • Willing to provide adequate locator information for study retention purposes and be reachable per local standard procedures

Exclusion Criteria:

  • Currently pregnant or last pregnancy within 3 months prior to enrolment
  • Currently breast-feeding
  • Participated in any other research study within 60 days prior to screening
  • Previously participated in any HIV vaccine study
  • Untreated urogenital infections within 2 weeks prior to enrolment
  • Presence of any abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy
  • History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, or urethral obstruction, incontinence or urge incontinence
  • Pap smear result at screening that requires cryotherapy, biopsy, treatment or further evaluation
  • Any Grade 2, 3 or 4 baseline (screening) haematology, chemistry or urinalysis laboratory abnormality according to the DAIDS Table for Grading Adverse Events
  • Any abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrolment
  • Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or silicone elastomer
  • Any serious acute, chronic or progressive disease
  • Any condition(s) that, in the opinion of the investigator, might interfere with adherence to study requirements or evaluation of the study objectives
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi,   Kenya,   South Africa,   Tanzania
Removed Location Countries Rwanda,   Zambia
 
Administrative Information
NCT Number  ICMJE NCT01071174
Other Study ID Numbers  ICMJE IPM 015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Annalene Nel, MBChB, PhD, International Partnership for Microbicides
Study Sponsor  ICMJE International Partnership for Microbicides, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dr Annalene Nel IPM
PRS Account International Partnership for Microbicides, Inc.
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP