A Phase 3 interventional study of Dapivirine Vaginal Ring in Human Immunodeficiency Virus, sponsored by International Partnership for Microbicides, Inc.. Completed at 17 sites in 4 countries. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by International Partnership for Microbicides, Inc. (part of Population Council) · Phase 3, Interventional, and Prevention
HIV Open-label Prevention Extension (HOPE).
A Phase 3B Open-Label Follow-on Trial to Assess the Continues Safety of and Adherence to a Vaginal ring Containing Dapivirine in Women
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 1,456 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →International Partnership for Microbicides, Inc. is the lead sponsor of 45 studies on the registry; none are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 5 (38%) have results posted.
First submitted before International Partnership for Microbicides, Inc. became part of Population Council.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women must meet all of the following criteria to be eligible for inclusion in the study
Exclusion Criteria:
Women who meet any of the following criteria will be excluded from the study
Per participant report at Screening:
Has any of the following laboratory abnormalities at Screening Visit:
Has any significant medical condition or other condition that, in the opinion of the IoR/designee, would preclude , make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
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.
Time frame: 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.
Time frame: 13 months
Incidence of HIV-1 Infection
HIV-1 infection as measured by the protocol algorithm
Time frame: 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
Time frame: 13 months
MTN-025 was implemented as a follow-on trial to MTN-020, and the inclusion and exclusion criteria were used to ensure the appropriate selection of trial participants for MTN-025. The Decliner Population were former MTN-020 participants who declined participation in the main MTN-025 trial, and who met the inclusion and exclusion criteria Women in the Decliner Population were invited to complete a single visit which consisted of behavioral assessments.
| Milestone | HIV Open-label Prevention |
|---|---|
| Started | 1456 |
| Exposed primary cohort | 1368 |
| Completed | 1404 |
| Not completed | 52 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal by subject | 18 |
| Withdrew: Participant relocated, no follow-up planned | 26 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Other | 4 |
Number of participants Grade 2, Grade 3, and all serious Adverse Events.
| Participants | HIV Open-label Prevention |
|---|---|
| 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 |
By measuring the residual levels of dapivirine in returned used vaginal rings.
| mg | HIV Open-label Prevention |
|---|---|
| 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) |
HIV-1 infection as measured by the protocol algorithm
| events per 100 person-years | HIV Open-label Prevention |
|---|---|
| Incidence of HIV-1 Infection | 2.7 |
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
| Participants | HIV Open-label Prevention |
|---|---|
| Number of Participant Who Acquired HIV-1 With HIV-1 Drug Resistance Associated Mutations. | 6 |
Collected over 13 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HIV Open-label Prevention | 1/1,368 (0.1%) | 19/1,368 (1.4%) | 844/1,368 (61.7%) |
| Event | HIV Open-label Prevention |
|---|---|
| GastrtitisGastrointestinal disorders | 1/1368 |
| Pelvic Inflammatory DiseaseInfections and infestations | 1/1368 |
| PneummoniaInfections and infestations | 1/1368 |
| Respiratory Track InfectionInfections and infestations | 1/1368 |
| Subcutaneous abscessInfections and infestations | 1/1368 |
| Animal BiteInjury, poisoning and procedural complications | 1/1368 |
| ContusionInjury, poisoning and procedural complications | 1/1368 |
| Head injuryInjury, poisoning and procedural complications | 1/1368 |
| Multiple injuriesInjury, poisoning and procedural complications | 1/1368 |
| Tendon injuryInjury, poisoning and procedural complications | 1/1368 |
| Event | HIV Open-label Prevention |
|---|---|
| Genitourinary chlamydia infectionInfections and infestations | 115/1368 |
| Vaginal dischargeReproductive system and breast disorders | 110/1368 |
| Vulvovaginitis trichomonalInfections and infestations | 81/1368 |
| Urinary Tract InfectionInfections and infestations | 71/1368 |
| Bacteria vaginosisInfections and infestations | 70/1368 |
| Upper respiratory tract infectionInfections and infestations | 67/1368 |
| Vulvovaginal CandidiasisInfections and infestations | 65/1368 |
| Genitourinary tract gonococcal infectionInfections and infestations | 58/1368 |
| Vulvovaginal pruritusReproductive system and breast disorders | 54/1368 |
| Pelvic painReproductive system and breast disorders | 45/1368 |
| Age, Continuous(Years) | HIV Open-label Prevention |
|---|---|
| Mean | 32.0 ± 6.51 |
| Sex: Female, Male(Participants) | HIV Open-label Prevention |
|---|---|
| Female | 1456 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | HIV Open-label Prevention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 8 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1276 |
| White | 0 |
| More than one race | 88 |
| Unknown or Not Reported | 84 |
| Region of Enrollment(participants) | HIV Open-label Prevention |
|---|---|
| Malawi | 157 |
| South Africa | 705 |
| Uganda | 172 |
| Zimbabwe | 422 |
| Marital Status(Participants) | HIV Open-label Prevention |
|---|---|
| Not Married | 770 |
| Married | 686 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
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Studies of the drug tested here: Dapivirine
Acquired Immunodeficiency Syndrome →
International Partnership for Microbicides, Inc. →