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Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dapivirine Vaginal Ring
Sponsored by
International Partnership for Microbicides, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Women must meet all of the following criteria to be eligible for inclusion in the study

  1. Previously enrolled in MTN-020 (ASPIRE)
  2. Able and willing to provide written informed consent to be screened for and to take part in the study
  3. Able and willing to provide adequate locator information, as defined in site SOPs
  4. HIV-uninfected based on testing performed by study staff at Screening and Enrollment
  5. Using an effective method of contraception at Enrollment, and intending to use an effective method for the duration of study participation; effective methods include hormonal methods (except contraceptive ring); intrauterine contraceptive device (IUCD); and sterilization (of participant, as defined in site SOPs)
  6. At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation

Exclusion Criteria:

Women who meet any of the following criteria will be excluded from the study

  1. Study product use permanently discontinued in response to an AE or safety related concern while taking part in the MTN-020 (ASPIRE) trial

  2. Per participant report at Screening:

    1. Plans to relocate away from the study site during study participation
    2. Plans to travel away from the study site for more than three consecutive months during study participation
  3. Per participant report at Enrollment, currently taking Post-Exposure Prophylaxis (PEP)
  4. With the exception of MTN-020 (ASPIRE), participation in any other research study involving drugs, medical devices, vaginal products, or vaccines, within 60 days of enrollment
  5. Is pregnant at Screening/Enrollment or planning to become pregnant in the participant's anticipated study participation period
  6. Currently breastfeeding
  7. Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), STI or reproductive tract infection (RTI) requiring treatment per WHO guidelines
  8. At Screening, has a clinically apparent Grade 3 pelvic exam finding (observed by study staff) as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009), Addendum 1-Female Genital Grading Table for Use in Microbicide Studies

  9. Has any of the following laboratory abnormalities at Screening Visit:

    1. Aspartate aminotransferase (AST) or alanine transaminase (ALT) > Grade 3*
    2. Creatinine > Grade 3*
    3. Hemoglobin > Grade 3*
    4. Platelet count > Grade 3*
    5. Pap result ≥ Grade 3 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009)

  10. Has any significant medical condition or other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

    -

Sites / Locations

  • Johns Hopkins University Research Project
  • Malawi Clinical Research Center
  • Medical Research Council of South Africa
  • WRHI Clinical Research Center
  • Botha's Hill Clinical Research Center
  • Chatsworth Clinical Research Center
  • Verulam Clinical Research Center
  • Isipingo Clinical Research Center
  • Tongaat Clinical Research Center
  • Emavundleni Research Centre
  • eThekwini Clinical Research Center
  • Wits Reproductive Health and HIV Institute Research Centre
  • Makerere University - Johns Hopkins University Research Collaboration Clinical Research Center
  • MU-JHU Research Collaboration
  • Seke South Clinical Research Center
  • Spilhaus Clinical Research Center
  • Zengeza Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIV Open-label Prevention

Arm Description

Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women MTN-020:NCT01617096 MTN-025: NCT02858037

Outcomes

Primary Outcome Measures

The Safety Profile Associated With the Open-label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
Number of participants Grade 2, Grade 3, and all serious Adverse Events.
Adherence to the Open Label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
By measuring the residual levels of dapivirine in returned used vaginal rings.

Secondary Outcome Measures

Incidence of HIV-1 Infection
HIV-1 infection as measured by the protocol algorithm
Number of Participant Who Acquired HIV-1 With HIV-1 Drug Resistance Associated Mutations.
HIV-1 drug resistance mutations among participants who acquire HIV-1, as measured by standard genotype analysis and more sensitive methods to detect low frequency drug-resistant variants

Full Information

First Posted
July 18, 2016
Last Updated
October 24, 2022
Sponsor
International Partnership for Microbicides, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02858037
Brief Title
Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women
Official Title
A Phase 3B Open-Label Follow-on Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 18, 2016 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
October 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Partnership for Microbicides, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
HIV Open-label Prevention Extension (HOPE).
Detailed Description
A Phase 3B Open-Label Follow-on Trial to Assess the Continues Safety of and Adherence to a Vaginal ring Containing Dapivirine in Women

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Participants will receive a silicone elastomer vaginal matrix ring containing 25 mg of dapivirine to be replaced each month for a total period of 12 months of use.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1456 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV Open-label Prevention
Arm Type
Experimental
Arm Description
Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women MTN-020:NCT01617096 MTN-025: NCT02858037
Intervention Type
Combination Product
Intervention Name(s)
Dapivirine Vaginal Ring
Intervention Description
Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
Primary Outcome Measure Information:
Title
The Safety Profile Associated With the Open-label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
Description
Number of participants Grade 2, Grade 3, and all serious Adverse Events.
Time Frame
13 months
Title
Adherence to the Open Label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
Description
By measuring the residual levels of dapivirine in returned used vaginal rings.
Time Frame
13 months
Secondary Outcome Measure Information:
Title
Incidence of HIV-1 Infection
Description
HIV-1 infection as measured by the protocol algorithm
Time Frame
13 months
Title
Number of Participant Who Acquired HIV-1 With HIV-1 Drug Resistance Associated Mutations.
Description
HIV-1 drug resistance mutations among participants who acquire HIV-1, as measured by standard genotype analysis and more sensitive methods to detect low frequency drug-resistant variants
Time Frame
13 months

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 must meet all of the following criteria to be eligible for inclusion in the study Previously enrolled in MTN-020 (ASPIRE) Able and willing to provide written informed consent to be screened for and to take part in the study Able and willing to provide adequate locator information, as defined in site SOPs HIV-uninfected based on testing performed by study staff at Screening and Enrollment Using an effective method of contraception at Enrollment, and intending to use an effective method for the duration of study participation; effective methods include hormonal methods (except contraceptive ring); intrauterine contraceptive device (IUCD); and sterilization (of participant, as defined in site SOPs) At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, vaginal products, or vaccines for the duration of study participation Exclusion Criteria: Women who meet any of the following criteria will be excluded from the study Study product use permanently discontinued in response to an AE or safety related concern while taking part in the MTN-020 (ASPIRE) trial Per participant report at Screening: Plans to relocate away from the study site during study participation Plans to travel away from the study site for more than three consecutive months during study participation Per participant report at Enrollment, currently taking Post-Exposure Prophylaxis (PEP) With the exception of MTN-020 (ASPIRE), participation in any other research study involving drugs, medical devices, vaginal products, or vaccines, within 60 days of enrollment Is pregnant at Screening/Enrollment or planning to become pregnant in the participant's anticipated study participation period Currently breastfeeding Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), STI or reproductive tract infection (RTI) requiring treatment per WHO guidelines At Screening, has a clinically apparent Grade 3 pelvic exam finding (observed by study staff) as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009), Addendum 1-Female Genital Grading Table for Use in Microbicide Studies Has any of the following laboratory abnormalities at Screening Visit: Aspartate aminotransferase (AST) or alanine transaminase (ALT) > Grade 3* Creatinine > Grade 3* Hemoglobin > Grade 3* Platelet count > Grade 3* Pap result ≥ Grade 3 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009) Has any significant medical condition or other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Steytler
Organizational Affiliation
International Partnership for Microbicides
Official's Role
Study Director
Facility Information:
Facility Name
Johns Hopkins University Research Project
City
Blantyre
Country
Malawi
Facility Name
Malawi Clinical Research Center
City
Lilongwe
Country
Malawi
Facility Name
Medical Research Council of South Africa
City
Westville
State/Province
Durban
ZIP/Postal Code
3630
Country
South Africa
Facility Name
WRHI Clinical Research Center
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Botha's Hill Clinical Research Center
City
Durban
State/Province
Kwa-Zulu Natal
Country
South Africa
Facility Name
Chatsworth Clinical Research Center
City
Durban
State/Province
Kwa-Zulu Natal
Country
South Africa
Facility Name
Verulam Clinical Research Center
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4340
Country
South Africa
Facility Name
Isipingo Clinical Research Center
City
Durban
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Tongaat Clinical Research Center
City
Durban
State/Province
KwaZulu-Natal
Country
South Africa
Facility Name
Emavundleni Research Centre
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7750
Country
South Africa
Facility Name
eThekwini Clinical Research Center
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Wits Reproductive Health and HIV Institute Research Centre
City
Johannesburg
Country
South Africa
Facility Name
Makerere University - Johns Hopkins University Research Collaboration Clinical Research Center
City
Kampala
Country
Uganda
Facility Name
MU-JHU Research Collaboration
City
Kampala
Country
Uganda
Facility Name
Seke South Clinical Research Center
City
Harare
Country
Zimbabwe
Facility Name
Spilhaus Clinical Research Center
City
Harare
Country
Zimbabwe
Facility Name
Zengeza Clinical Research Center
City
Harare
Country
Zimbabwe

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33539762
Citation
Baeten JM, Palanee-Phillips T, Mgodi NM, Mayo AJ, Szydlo DW, Ramjee G, Gati Mirembe B, Mhlanga F, Hunidzarira P, Mansoor LE, Siva S, Govender V, Makanani B, Naidoo L, Singh N, Nair G, Chinula L, Parikh UM, Mellors JW, Balan IC, Ngure K, van der Straten A, Scheckter R, Garcia M, Peda M, Patterson K, Livant E, Bunge K, Singh D, Jacobson C, Jiao Y, Hendrix CW, Chirenje ZM, Nakabiito C, Taha TE, Jones J, Torjesen K, Nel A, Rosenberg Z, Soto-Torres LE, Hillier SL, Brown ER; MTN-025/HOPE Study Team. Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study. Lancet HIV. 2021 Feb;8(2):e87-e95. doi: 10.1016/S2352-3018(20)30304-0.
Results Reference
derived
PubMed Identifier
32920652
Citation
Kutner BA, Giguere R, Lentz C, Kajura-Manyindo C, Dolezal C, Butheliezi S, Gwande M, Nampiira S, Ndlovu T, Mvinjelwa P, Mwenda W, Balan IC. Sharing Objective Measures of Adherence to a Vaginal Microbicide Promotes Candor About Actual Use and Bolsters Motivation to Prevent HIV. AIDS Behav. 2021 Mar;25(3):721-731. doi: 10.1007/s10461-020-03026-6. Epub 2020 Sep 12.
Results Reference
derived

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Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in Women

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