NCT02858037

Brief Summary

HIV Open-label Prevention Extension (HOPE).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,456

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2016

Geographic Reach
4 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

July 18, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
4 years until next milestone

Results Posted

Study results publicly available

October 25, 2022

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

2.2 years

First QC Date

July 18, 2016

Results QC Date

June 15, 2022

Last Update Submit

October 24, 2022

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (2)

  • 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.

    13 months

  • 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.

    13 months

Secondary Outcomes (2)

  • Incidence of HIV-1 Infection

    13 months

  • Number of Participant Who Acquired HIV-1 With HIV-1 Drug Resistance Associated Mutations.

    13 months

Study Arms (1)

HIV Open-label Prevention

EXPERIMENTAL

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

Combination Product: Dapivirine Vaginal Ring

Interventions

Dapivirine Vaginal RingCOMBINATION_PRODUCT

Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.

HIV Open-label Prevention

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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\*
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Johns Hopkins University Research Project

Blantyre, Malawi

Location

Malawi Clinical Research Center

Lilongwe, Malawi

Location

Medical Research Council of South Africa

Westville, Durban, 3630, South Africa

Location

WRHI Clinical Research Center

Johannesburg, Gauteng, South Africa

Location

Verulam Clinical Research Center

Durban, KwaZulu-Natal, 4340, South Africa

Location

Botha's Hill Clinical Research Center

Durban, KwaZulu-Natal, South Africa

Location

Chatsworth Clinical Research Center

Durban, KwaZulu-Natal, South Africa

Location

Isipingo Clinical Research Center

Durban, KwaZulu-Natal, South Africa

Location

Tongaat Clinical Research Center

Durban, KwaZulu-Natal, South Africa

Location

Emavundleni Research Centre

Cape Town, Western Cape, 7750, South Africa

Location

eThekwini Clinical Research Center

Durban, 4001, South Africa

Location

Wits Reproductive Health and HIV Institute Research Centre

Johannesburg, South Africa

Location

Makerere University - Johns Hopkins University Research Collaboration Clinical Research Center

Kampala, Uganda

Location

MU-JHU Research Collaboration

Kampala, Uganda

Location

Seke South Clinical Research Center

Harare, Zimbabwe

Location

Spilhaus Clinical Research Center

Harare, Zimbabwe

Location

Zengeza Clinical Research Center

Harare, Zimbabwe

Location

Related Publications (2)

  • 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.

    PMID: 33539762DERIVED

  • 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.

    PMID: 32920652DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Limitations and Caveats

Interpretation of the HIV-1 incidence rates is limited by the lack of a concurrent placebo group in MTN-025. Dapivirine residual levels in returned used rings do not provide adherence information at the time of potential exposure to and infection with HIV, eg, if a participant temporarily removes the DVR during sexual intercourse.

Results Point of Contact

Title
Dr John Steytler
Organization
International Partnership for Microbicides
jsteytler@ipmglobal.org
+27 21 860 2300

Study Officials

  • John Steytler

    International Partnership for Microbicides

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

August 8, 2016

Study Start

July 18, 2016

Primary Completion

October 10, 2018

Study Completion

October 10, 2018

Last Updated

October 25, 2022

Results First Posted

October 25, 2022

Record last verified: 2022-10

Locations

ZA(10)UG(2)ZI(3)MA(2)