A Safety Study of Dapivirine Vaginal Ring in Africa

August 1, 2011 updated by: International Partnership for Microbicides, Inc.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kisumu, Kenya
        • Kenya Medical Research Institute (KEMRI)
  • Malawi
      • Lilongwe, Malawi
        • University of North Carolina Project
  • South Africa
    • Kwazulu Natal
      • Edendale, Kwazulu Natal, South Africa
        • Reproductive Health and HIV Research Unit (RHRU)
      • Ladysmith, Kwazulu Natal, South Africa
        • Qhakaza Mbokodo
      • Pinetown, Kwazulu Natal, South Africa
        • Prevention for HIV and AIDS Project (PHIVA)
    • North West
      • Brits, North West, South Africa
        • Madibeng Centre for Research
    • Western Cape
      • Cape Town, Western Cape, South Africa
        • Desmond Tutu HIV Foundation Masiphumelele
      • Cape Town, Western Cape, South Africa
        • Desmond Tutu HIV Foundation Nyanga
      • Paarl, Western Cape, South Africa
        • Be Part Yoluntu Centre Mbekweni
  • Tanzania
      • Moshi, Tanzania
        • Kilimanjaro Christian Medical Centre (KCMC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Ring
Vaginal Ring containing no drug substance
Other: Placebo
Vaginal Ring containing no drug substance
Experimental: Dapivirine Ring
Dapivirine Vaginal Ring 25mg
Other: Dapivirine
Vaginal ring containing 25mg dapivirine; One ring inserted every 28 days for 84 days (3 rings total)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Acceptability of the product determined by questionnaire.
Time Frame: 16 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Partnership for Microbicides, Inc.

Investigators

  • Study Director: Dr Annalene Nel, IPM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

February 18, 2010

First Posted (Estimate)

February 19, 2010

Study Record Updates

Last Update Posted (Estimate)

August 2, 2011

Last Update Submitted That Met QC Criteria

August 1, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPM 015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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