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A Safety Study of Dapivirine Vaginal Ring in Africa

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Dapivirine
Placebo
Sponsored by
International Partnership for Microbicides, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV infections, Anti-HIV agents, HIV-1

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kenya Medical Research Institute (KEMRI)
  • University of North Carolina Project
  • Reproductive Health and HIV Research Unit (RHRU)
  • Qhakaza Mbokodo
  • Prevention for HIV and AIDS Project (PHIVA)
  • Madibeng Centre for Research
  • Desmond Tutu HIV Foundation Masiphumelele
  • Desmond Tutu HIV Foundation Nyanga
  • Be Part Yoluntu Centre Mbekweni
  • Kilimanjaro Christian Medical Centre (KCMC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Ring

Dapivirine Ring

Arm Description

Vaginal Ring containing no drug substance

Dapivirine Vaginal Ring 25mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acceptability of the product determined by questionnaire.
Adherence to the protocol-specific product regimen as determined by self-report and clinician observation at each study visit.

Full Information

First Posted
February 17, 2010
Last Updated
August 1, 2011
Sponsor
International Partnership for Microbicides, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01071174
Brief Title
A Safety Study of Dapivirine Vaginal Ring in Africa
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
International Partnership for Microbicides, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV infections, Anti-HIV agents, HIV-1

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Ring
Arm Type
Placebo Comparator
Arm Description
Vaginal Ring containing no drug substance
Arm Title
Dapivirine Ring
Arm Type
Experimental
Arm Description
Dapivirine Vaginal Ring 25mg
Intervention Type
Other
Intervention Name(s)
Dapivirine
Intervention Description
Vaginal ring containing 25mg dapivirine; One ring inserted every 28 days for 84 days (3 rings total)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Vaginal Ring containing no drug substance
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Acceptability of the product determined by questionnaire.
Time Frame
16 weeks
Title
Adherence to the protocol-specific product regimen as determined by self-report and clinician observation at each study visit.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Annalene Nel
Organizational Affiliation
IPM
Official's Role
Study Director
Facility Information:
Facility Name
Kenya Medical Research Institute (KEMRI)
City
Kisumu
Country
Kenya
Facility Name
University of North Carolina Project
City
Lilongwe
Country
Malawi
Facility Name
Reproductive Health and HIV Research Unit (RHRU)
City
Edendale
State/Province
Kwazulu Natal
Country
South Africa
Facility Name
Qhakaza Mbokodo
City
Ladysmith
State/Province
Kwazulu Natal
Country
South Africa
Facility Name
Prevention for HIV and AIDS Project (PHIVA)
City
Pinetown
State/Province
Kwazulu Natal
Country
South Africa
Facility Name
Madibeng Centre for Research
City
Brits
State/Province
North West
Country
South Africa
Facility Name
Desmond Tutu HIV Foundation Masiphumelele
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Desmond Tutu HIV Foundation Nyanga
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Be Part Yoluntu Centre Mbekweni
City
Paarl
State/Province
Western Cape
Country
South Africa
Facility Name
Kilimanjaro Christian Medical Centre (KCMC)
City
Moshi
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
26963505
Citation
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.
Results Reference
derived

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A Safety Study of Dapivirine Vaginal Ring in Africa

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