Human Immunodeficiency VirusPhase 3NCT02858037

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

A Phase 3 study testing Dapivirine Vaginal Ring in people with Human Immunodeficiency Virus, run by International Partnership for Microbicides, Inc. at 17 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

HIV Open-label Prevention Extension (HOPE). Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Virus
What is being tested?: Dapivirine Vaginal Ring
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,456 participants
Where: 17 sitesin 4 countries
Study dates: 18 Jul 2016to 10 Oct 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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)

Show all 19Show fewer

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
-

Trial locations and contacts

17 sites in 4 countries.

Country

City, postcode or hospital

17 sites in 4 countries

South Africa10 sites

Emavundleni Research Centre
Cape Town, Western Cape, 7750
Verulam Clinical Research Center
Durban, KwaZulu-Natal, 4340
Botha's Hill Clinical Research Center
Durban, KwaZulu-Natal
Chatsworth Clinical Research Center
Durban, KwaZulu-Natal
Isipingo Clinical Research Center
Durban, KwaZulu-Natal
Tongaat Clinical Research Center
Durban, KwaZulu-Natal
eThekwini Clinical Research Center
Durban, 4001
WRHI Clinical Research Center
Johannesburg, Gauteng
Wits Reproductive Health and HIV Institute Research Centre
Johannesburg
Medical Research Council of South Africa
Westville, Durban, 3630

Other trials in South Africa

Zimbabwe3 sites

Seke South Clinical Research Center
Harare
Spilhaus Clinical Research Center
Harare
Zengeza Clinical Research Center
Harare

Other trials in Zimbabwe

Malawi2 sites

Johns Hopkins University Research Project
Blantyre
Malawi Clinical Research Center
Lilongwe

Other trials in Malawi

Uganda2 sites

Makerere University - Johns Hopkins University Research Collaboration Clinical Research Center
Kampala
MU-JHU Research Collaboration
Kampala

Other trials in Uganda

About this study

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

HIV Open-label Prevention Extension (HOPE).

Read the 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

Conditions: Human Immunodeficiency Virus
Being tested: Dapivirine Vaginal Ring
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02858037
Study group	Role	What they receive
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 Receives: Combination Product: Dapivirine Vaginal Ring

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 13 months

Secondary outcomes (2)

Incidence of HIV-1 Infection
HIV-1 infection as measured by the protocol algorithm
Measured: 13 months
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
Measured: 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jul 201610 Oct 2018

First posted8 Aug 2016 (estimated)
Study start18 Jul 2016
Primary completion10 Oct 2018
Study completion10 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 1,456 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02858037
Sponsor's protocol ID: MTN-025
Status last verified: Oct 2022
First submitted: 18 Jul 2016
Last updated: 25 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 33539762
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.
PubMed 32920652

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02858037
Acronym / sponsor ID: MTN-025
Conditions: Human Immunodeficiency Virus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,456 participants (actual)
Lead sponsor: International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
Study start: 18 Jul 2016 (actual)
Primary completion: 10 Oct 2018 (actual)
Study completion: 10 Oct 2018 (actual)
First posted: 8 Aug 2016 (estimated)
Results: Posted 25 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
HIV Open-label Prevention	Experimental	Combination Product: Dapivirine Vaginal RingFollowing 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

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (19 listed)

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:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dapivirine Vaginal RingDapivirine Vaginal Ring, 25 ring given monthly for at least one year.	Combination product	HIV Open-label Prevention

Primary outcome

The Safety Profile Associated With the Open-label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women
Time frame: 13 months
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
Time frame: 13 months
By measuring the residual levels of dapivirine in returned used vaginal rings.

2 secondary outcomes

Incidence of HIV-1 Infection
Time frame: 13 months
Number of Participant Who Acquired HIV-1 With HIV-1 Drug Resistance Associated Mutations.
Time frame: 13 months

Results and safety

Results posted to the registry on 25 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HIV Open-label Prevention	1,456	1,404

Primary outcome: The Safety Profile Associated With the Open-label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women

Time frame: 13 months. Count of participants. Unit: Participants

Measure	HIV Open-label Prevention n = 1368
At least one Grade 3 or higher AE	52
At least one serious AE	19
At least one grade 2 or higher related AE	2

Population analysed: Exposed Primary Cohort - included all participants enrolled in the Main Trial Population

Primary outcome: Adherence to the Open Label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women

Time frame: 13 months. Mean (Full Range). Unit: mg

Measure	HIV Open-label Prevention n = 1365
Enrollment	21.0 (17.7 to 25.9)
Month 1	21.1 (17.0 to 26.3)
Month 2	21.0 (16.5 to 27.1)
Month 3	21.1 (16.4 to 27.8)
Month 6	21.2 (16.6 to 27.3)
Month 9	21.3 (15.8 to 27.1)

Population analysed: Exposed Human Immunodeficiency Virus Incidence and Adherence Cohort

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 13 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIV Open-label Prevention	19 of 1,368 (1.4%)	844 of 1,368 (61.7%)	1 of 1,368

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33539762Baeten 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.
Derived from this study: PubMed 32920652Kutner 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.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Steytler study director

International Partnership for Microbicides

17 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapivirine Vaginal Ring in people with Human Immunodeficiency Virus, run by International Partnership for Microbicides, Inc. at 17 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in South Africa, Zimbabwe, Malawi, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Safety Profile Associated With the Open-label Use of the Dapivirine Vaginal Matrix Ring (25 mg) in Women (time frame: 13 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02858037, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.