Long-acting HIV Pre-Exposure Prophylaxis Integrated With Community-based Sexual and Reproductive Health in South Africa (LAPIS): A Hybrid (1a) Cluster Randomised Controlled Phase 3B Trial of Effectiveness and Implementation

The goal of this hybrid (1a) Cluster Randomised Controlled Trial phase 3B trial is to evaluate the effectiveness and implementation of offering a choice of HIV Pre-Exposure Products (PrEP) through community-based sexual and reproductive health services, on PrEP uptake and retention, and population prevalence of sexually transmissible HIV amongst adolescents and young adults living in rural South Africa.
Researchers will compare adding the choice of long-acting PrEP, i.e. two monthly injectable cabotegravir (CAB LA) or dapiravine vaginal ring and HIV post exposure prophylaxis packs to daily oral PrEP integrated with community-based SRH in the 20 intervention clusters with standard of care (SoC), daily oral PrEP integrated with community-based SRH in the 20 control clusters, on uptake and retention on PrEP. We hypothesise that offering a choice of long-acting or oral PrEP and PEP within the community-based delivery of SRH services will overcome the challenges and barriers to effective use of oral daily PrEP and lead to a population-level effect on uptake and retention on PrEP and thus the prevalence of sexually transmissible HIV amongst 15-30 year olds living in rural KwaZulu-Natal, South Africa.

开始日期2024-02-27

申办/合作机构-

NCT06807736

/ RecruitingN/AIIT

PrEPared to Choose (PtC): an Implementation Study of the Delivery of Cabotegravir Long-acting Injectable Pre-exposure Prophylaxis (PrEP) As an HIV Prevention Product Option Within a PrEP Choice Context in a Real World Setting in Cape Town.

The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period. The study has both clinical and implementation primary aims. The primary clinical aim is short and long-term persistence on PrEP. Persistence is defined as the length of time that a participant shows continuous use of a PrEP product as intended, without stopping PrEP or switching to another PrEP product. The primary implementation aim involves the determination of factors that either enable or serve as a barrier to PrEP uptake and continuation.
Participants will be offered a choice between three antiretroviral-containing PrEP products: (1) a Tenofovir-based oral tablet that needs to be taken daily; (2) a vaginal ring containing Dapivirine that provides HIV protection for up to one month; and (3) an intramuscular injection containing Cabotegravir that provides HIV protection for up to two months. Participants will be able to use the same product throughout the study, switch between products, or stop and restart on PrEP at any point.
The study will be offered from two study sites: the first is a mobile clinic that rotates on a fixed schedule across the study area and the second is a fixed-location government primary healthcare clinic. The study will be open to confirmed HIV-negative individuals, including adolescent girls and young women (aged 15-29 years), young gender and sexually diverse populations aged 15-29 years (including men who have sex with men, transgender people, and non-binary people), and their collective sexual partners (including heterosexual, cisgender men) of any age.

开始日期2024-02-13

申办/合作机构

Desmond Tutu Hiv Foundation

[+2]

NCT05416021

/ Completed临床1期

A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 Inserted Every 30 Days and 100 mg DPV Ring-008 Inserted for 90 Days in Healthy Female Participants

A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 inserted every 30 days and 100 mg Dapivirine Vaginal Ring-008 inserted for 90 days in Healthy Female Participants

开始日期2022-08-01

申办/合作机构

INC Research Holdings, Inc.

100 项与 Dapivirine 相关的临床结果

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100 项与 Dapivirine 相关的转化医学

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100 项与 Dapivirine 相关的专利（医药）

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385

项与 Dapivirine 相关的文献（医药）

2025-04-01·Therapeutic Advances in Infectious Disease

Exploring pregnant women’s experiences with dapivirine vaginal ring insertion during the MTN-042/DELIVER study in Uganda: a description of secondary data

Article

作者: Ssemambo, Phionah Kibalama ; Nalwoga, Justine ; Ssekasi, Annette Miwanda ; Nakabiito, Clemensia ; Mirembe, Brenda Gati ; Nansimbe, Joselyne ; Byogero, Rose

Background::

Involving pregnant women in HIV prevention trials is key to ensuring that they benefit from efficacious products. MTN-042/DELIVER was a phase IIIb, open-label, multi-site, randomized safety study, the first of its kind to enroll HIV-negative pregnant women into a prevention trial using oral Truvada ® once daily and the Dapivirine Vaginal Ring (DVR) every month. There is limited data on pregnant women’s experiences with ring insertion, which we explored.

Objectives::

To explore the experiences of pregnant women with DVR insertion during the MTN-042/DELIVER study at MU-JHU Care Limited in Kampala, Uganda.

Design::

A description of secondary data from the MTN-042/DELIVER study.

Methods::

Participant randomization was to either DVR or Truvada in varying ratios into three successive cohorts (based on gestational age). Ring self-insertion was required at enrolment and every 4 weeks until delivery. Pre-insertion counselling and supervised ring placement assessment were done. Enrollment data were collected to include counselling sessions, insertion tactics, ring self-insertion scores (Very difficult: 3+ attempts and/or pain, severe discomfort, Difficult: 2 attempts and/or moderate discomfort, Easy: 1 attempt with some ring repositioning and/or mild discomfort, Very easy: Smooth insertion and positioning in one attempt with no discomfort), assistance during insertion, encountered challenges and ring expulsion during use.

Results::

Out of 154 participants, 73% were randomized to the ring. At enrolment, all participants attempted self-insertion. Only one participant required additional counselling. The squatting position was uniformly favoured. Across all cohorts, 95% of participants had easy/very easy ring self-insertion. Five percent had difficult ring self-insertion, with some variations across cohorts. Challenges included difficulty in folding, gripping, inserting the ring far enough, requiring multiple attempts and reluctance to insert it. No expulsions during ring use were reported.

Conclusion::

Most pregnant women managed to insert the Ring themselves. However, participants above 36 weeks required more help with ring insertion compared to others. This suggests that it may be beneficial to encourage pregnant women to start using this HIV prevention method early in pregnancy, to minimize potential initial insertion challenges in late pregnancy.

Trial registration::

The primary study, MTN-042/DELIVER is registered as ID NCT03965923 at https://www.ClinicalTrials.gov .

2025-04-01·INTERNATIONAL JOURNAL OF PHARMACEUTICS

A multipurpose silicone elastomer vaginal ring releasing dapivirine and Cu2+/Zn2+ ions for HIV prevention and non-hormonal contraception

Article

作者: Zhao, Xinyu ; Shen, Xin ; Malcolm, R Karl ; Dallal Bashi, Yahya H ; McCoy, Clare F ; Boyd, Peter

A dapivirine (DPV)-releasing vaginal ring (DapiRing®, containing 25 mg DPV) has been approved in various African countries for prevention of human immunodeficiency virus type 1 (HIV-1). Current research is focused on next-generation multipurpose prevention technology (MPT) vaginal rings that additionally provide contraception, and a combination dapivirine + levonorgestrel ring is in clinical development. However, hormonal contraceptives have numerous side effects and contraindications, and many women are interested in hormone-free contraceptive options. Copper and zinc have well documented spermicidal activity; for example, copper intrauterine devices-comprising a copper metal wire fitted to a polyethylene frame and releasing cupric (Cu²⁺) ions-have a long history of use as a long-actingreversible non-hormonal form of contraception. Here, we report a multipurpose vaginal ring offering sustained release of DPV, Cu²⁺ ions, and Zn²⁺ ions. Matrix-type silicone elastomer vaginal rings containing different combinations of DPV (25 mg) and various copper/zinc substances (copper nanopowders, zinc nanopowders, copper sulphate pentahydrate, and zinc acetate dihydrate) were successfully manufactured by injection molding. DPV and the metal nanopowders were stable during manufacturing; partial dehydration occurred with copper sulphate pentahydrate and zinc acetate dihydrate. Incorporation of copper/zinc substances had minimal impact on DPV release, and the formulations produced similar DPV release compared with DapiRing®. Rings containing metal salts released significantly more Cu²⁺/Zn²⁺ ions than those containing metal nanopowders, and greater quantities of Cu²⁺/Zn²⁺ ions compared with marketed copper IUDs or experimental copper-zinc IUDs. The results demonstrate that copper/zinc metals and salts can be effectively incorporated into and released from silicone elastomer vaginal rings and are compatible with DPV. The inclusion of copper/zinc offers potential as non-hormonal contraception and warrants further investigation in the context of MPTs.

2025-03-01·INTERNATIONAL JOURNAL OF STD & AIDS

Understanding the sources of efficacy dilution in a trial of a monthly dapivirine vaginal ring for HIV-1 prevention

Article

作者: Peebles, Kathryn ; Brown, Elizabeth R ; Baeten, Jared M ; Palanee-Phillips, Thesla ; Matrajt, Laura

Introduction:

Women-initiated HIV – 1 prevention products are key to reducing women’s HIV-1 risk. Clinical trials of vaginal microbicides have shown limited to no efficacy in intention-to-treat (ITT) analyses. It is hypothesized that these negative results are partly due to efficacy dilution.

Methods:

We developed a microsimulation model of MTN-020/ASPIRE, a phase 3 trial that evaluated monthly use of a dapivirine vaginal ring for HIV-1 prevention. We evaluated four sources of efficacy dilution: trial-level factors: (i) an imbalance in the number of monthly sex acts between study arms and (ii) heterogeneity in risk emergent over time; and individual-level factors: (iii) product non-adherence and (iv) receptive anal intercourse.

Results:

Assuming 70% per-vaginal exposure efficacy (consistent with the ITT estimate of 27%), heterogeneity in risk accounted for the largest proportion of efficacy dilution, at 42% (90% CrI: 38, 45), followed by non-adherence (33%; 90% CrI: 27, 39), an imbalance in arms (18%; 90% CrI: 16, 21) and lastly, anal intercourse with less than 10% of efficacy dilution.

Conclusion:

Our results suggest that heterogeneity in risk was the most important source of efficacy dilution in the ASPIRE trial. Future trials of HIV-1 prevention products for women should consider alternative trial designs and analytic approaches that minimize bias introduced by heterogeneity in risk.

项与 Dapivirine 相关的新闻（医药）

2023-01-18

·PipelineReview

Janssen and Global Partners to Discontinue Phase 3 Mosaico HIV Vaccine Clinical Trial

Independent, scheduled review of Phase 3 Mosaico study finds investigational vaccine regimen lacks efficacy in preventing HIV No vaccine-related safety issues identified LEIDEN, THE NETHERLANDS I January 18, 2023 I The Janssen Pharmaceutical Companies of Johnson & Johnson, together with a consortium of global partners, today announced the results of an independent, scheduled data review of the Phase 3 Mosaico study (also known as HPX3002/HVTN706) of Janssen’s investigational HIV vaccine regimen. The study’s independent Data and Safety Monitoring Board (DSMB) determined that the regimen was not effective in preventing HIV infection compared to placebo among study participants. No safety issues with the vaccine regimen were identified. In light of the DSMB’s determination, the Mosaico clinical trial will be discontinued. Participant notifications and further analyses of the data are underway. Throughout the trial, study investigators have ensured that any individuals who contracted HIV received prompt HIV treatment and care. “We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. “Though there have been significant advances in prevention since the beginning of the global epidemic, 1.5 million people acquired HIV in 2021 alone, underscoring the high unmet need for new options and why we have long worked to tackle this global health challenge. We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine. We are grateful to our Mosaico partners and the study investigators, staff and participants.” About the Phase 3 Mosaico Study Mosaico, a Phase 3 study of Janssen’s investigational HIV vaccine regimen, began in 2019, and completed vaccinations in October 2022. The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people, who represent groups and populations vulnerable to HIV, at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain and the United States. The study evaluated an investigational vaccine regimen containing a mosaic-based adenovirus serotype 26 vector (Ad26.Mos4.HIV) administered during four vaccination visits over one year. A mix of soluble proteins (Clade C/Mosaic gp140, adjuvanted with aluminum phosphate) was also administered at visits three and four. The Mosaico DSMB analysis, based on the data available to date, indicated that the regimen does not protect against HIV and the study is not expected to meet its primary endpoint. No safety issues with the vaccine regimen were identified. In light of this, the study will be discontinued, and further analyses are underway. The DSMB’s determination follows the primary analysis of the Phase 2b Imbokodo study, which was announced in August 2021 and found that a similar investigational HIV vaccine regimen did not provide sufficient protection against HIV in a population of young women in sub-Saharan Africa. The investigational vaccine regimen used in the Imbokodo study was found to have a favorable safety profile. The Mosaico study was led by a global public-private partnership including the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), the HIV Vaccine Trials Network (HVTN), the U.S. Army Medical Research and Development Command (USAMRDC), and Janssen Vaccines & Prevention B.V. Since 2005, Janssen Vaccines & Prevention B.V. has been participating as a sub-grantee in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526, AI096040 and AI128751 (Principal Investigator, Prof. Dan Barouch). Johnson & Johnson’s Commitment to HIV Johnson & Johnson has been committed to the fight against HIV for decades, playing a key role in bringing nine therapeutics to people living with HIV and continuing to drive innovation in HIV prevention and care. In January 2021, the dapivirine ring, a discreet long-acting HIV prevention method specifically developed for women by the International Partnership for Microbicides (IPM) and based on Janssen’s compound, was recommended by the World Health Organization as an additional prevention choice for women with a substantial chance of contracting HIV as part of combination prevention approaches. In July 2021 , Zimbabwe became the first country to approve the use of the dapivirine ring among women ages 18 and older, with South Africa following suit in March 2022 . Additional regulatory decisions are pending. Johnson & Johnson also works with vulnerable communities on the frontlines of the HIV epidemic, and has supported collaborative initiatives like the DREAMS Partnership in sub-Saharan Africa, the MenStar Coalition , and the New Horizons Collaborative . To learn more about Johnson & Johnson’s commitment to combatting HIV, please visit jnj.com/hiv . About Johnson & Johnson At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That’s why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest diversified healthcare products company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. We are blending our heart, science, and ingenuity to profoundly change the trajectory of health for humanity. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension. Learn more at http://www.janssen.com and follow us at http://www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS . Janssen Vaccines & Prevention, B.V. and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. SOURCE: Johnson & Johnson

疫苗临床2期临床3期临床结果

2023-01-18

·Johnson & Johnson

Janssen and Global Partners to Discontinue Phase 3 Mosaico HIV Vaccine Clinical Trial

LEIDEN, THE NETHERLANDS, (January 18, 2023) – The Janssen Pharmaceutical Companies of Johnson & Johnson, together with a consortium of global partners, today announced the results of an independent, scheduled data review of the Phase 3 Mosaico study (also known as HPX3002/HVTN706) of Janssen’s investigational HIV vaccine regimen. The study’s independent Data and Safety Monitoring Board (DSMB) determined that the regimen was not effective in preventing HIV infection compared to placebo among study participants. No safety issues with the vaccine regimen were identified.In light of the DSMB’s determination, the Mosaico clinical trial will be discontinued. Participant notifications and further analyses of the data are underway. Throughout the trial, study investigators have ensured that any individuals who contracted HIV received prompt HIV treatment and care.“We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. “Though there have been significant advances in prevention since the beginning of the global epidemic, 1.5 million people acquired HIV in 2021 alone, underscoring the high unmet need for new options and why we have long worked to tackle this global health challenge. We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine. We are grateful to our Mosaico partners and the study investigators, staff and participants.”About the Phase 3 Mosaico StudyMosaico, a Phase 3 study of Janssen’s investigational HIV vaccine regimen, began in 2019, and completed vaccinations in October 2022. The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people, who represent groups and populations vulnerable to HIV, at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain and the United States.The study evaluated an investigational vaccine regimen containing a mosaic-based adenovirus serotype 26 vector (Ad26.Mos4.HIV) administered during four vaccination visits over one year. A mix of soluble proteins (Clade C/Mosaic gp140, adjuvanted with aluminum phosphate) was also administered at visits three and four.The Mosaico DSMB analysis, based on the data available to date, indicated that the regimen does not protect against HIV and the study is not expected to meet its primary endpoint. No safety issues with the vaccine regimen were identified. In light of this, the study will be discontinued, and further analyses are underway.The DSMB’s determination follows the primary analysis of the Phase 2b Imbokodo study, which was announced in August 2021 and found that a similar investigational HIV vaccine regimen did not provide sufficient protection against HIV in a population of young women in sub-Saharan Africa. The investigational vaccine regimen used in the Imbokodo study was found to have a favorable safety profile.The Mosaico study was led by a global public-private partnership including the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), the HIV Vaccine Trials Network (HVTN), the U.S. Army Medical Research and Development Command (USAMRDC), and Janssen Vaccines & Prevention B.V. Since 2005, Janssen Vaccines & Prevention B.V. has been participating as a sub-grantee in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526, AI096040 and AI128751 (Principal Investigator, Prof. Dan Barouch).Johnson & Johnson’s Commitment to HIVJohnson & Johnson has been committed to the fight against HIV for decades, playing a key role in bringing nine therapeutics to people living with HIV and continuing to drive innovation in HIV prevention and care.In January 2021, the dapivirine ring, a discreet long-acting HIV prevention method specifically developed for women by the International Partnership for Microbicides (IPM) and based on Janssen’s compound, was recommended by the World Health Organization as an additional prevention choice for women with a substantial chance of contracting HIV as part of combination prevention approaches. In July 2021, Zimbabwe became the first country to approve the use of the dapivirine ring among women ages 18 and older, with South Africa following suit in March 2022. Additional regulatory decisions are pending.Johnson & Johnson also works with vulnerable communities on the frontlines of the HIV epidemic, and has supported collaborative initiatives like the DREAMS Partnership in sub-Saharan Africa, the MenStar Coalition, and the New Horizons Collaborative.To learn more about Johnson & Johnson’s commitment to combatting HIV, please visit jnj.com/hiv.About Johnson & JohnsonAt Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That’s why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest diversified healthcare products company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. We are blending our heart, science, and ingenuity to profoundly change the trajectory of health for humanity.About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.Learn more at http://www.janssen.com and follow us at http://www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Vaccines & Prevention, B.V. and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.Cautions Concerning Forward-Looking StatementsThis press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding Janssen’s investigational, mosaic-based HIV vaccine regimen. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Vaccines & Prevention, B.V., the Janssen Pharmaceutical Companies, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities of the agreement may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2022, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Report on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Vaccines & Prevention, B.V., the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

疫苗临床2期临床3期临床结果

100 项与 Dapivirine 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11246	Dapivirine	G01AX17	DB08639

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
HIV感染	临床3期	肯尼亚	INC Research Holdings, Inc.	2011-07-01
HIV感染	临床3期	肯尼亚	International Partnership for Microbicides	2011-07-01
HIV感染	临床3期	马拉维	INC Research Holdings, Inc.	2011-07-01
HIV感染	临床3期	卢旺达	INC Research Holdings, Inc.	2011-07-01
HIV感染	临床3期	卢旺达	International Partnership for Microbicides	2011-07-01
HIV感染	临床3期	南非	INC Research Holdings, Inc.	2011-07-01
HIV感染	临床3期	津巴布韦	INC Research Holdings, Inc.	2011-07-01
获得性免疫缺陷综合征	临床2期	南非	INC Research Holdings, Inc.	2009-07-01
获得性免疫缺陷综合征	临床2期	南非	International Partnership for Microbicides	2009-07-01
避孕	临床1期	美国	International Partnership for Microbicides	2018-07-17

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04140266 (MTN-043, Pubmed \| Lancet HIV)	临床3期	母乳喂养	197	Dapivirine vaginal ring (DVR)	鏇鹽顧夢鏇淵觸窪餘鹹(鹽觸簾壓繭簾壓膚壓製) = 夢鑰遞遞憲選鏇鹽觸醖糧廠艱艱鹹壓積蓋衊獵 (繭淵鑰蓋繭繭糧窪夢艱 )	积极	2025-03-01
NCT01617096 (MTN-020/ASPIRE, Pubmed \| J Infect Dis)	临床3期	HIV感染	-	Dapivirine Vaginal Ring	衊鏇夢築窪艱醖憲醖蓋(襯齋鏇蓋網醖餘鏇廠鏇) = 窪網廠糧齋壓遞衊鑰遞獵範壓積鬱糧襯遞蓋窪 (淵遞憲膚構積簾夢蓋鏇, 1.8 ~ 3.1)	积极	2024-04-12
				Placebo	衊鏇夢築窪艱醖憲醖蓋(襯齋鏇蓋網醖餘鏇廠鏇) = 夢鑰築餘憲繭顧範範積獵範壓積鬱糧襯遞蓋窪 (淵遞憲膚構積簾夢蓋鏇, 2.9 ~ 4.4)
NCT01539226 (The Ring Study, Pubmed \| BMJ Open) 人工标引	N/A	HIV感染	197	Dapivirine vaginal ring / placebo vaginal ring	蓋襯齋鹽繭壓顧膚遞夢(膚廠衊製淵獵艱構獵糧) = 廠願獵網鹽簾願築繭夢遞築餘醖範顧鹽餘夢選 (願夢鹹鏇簾鬱觸襯襯範, 44.7 ~ 60.3) 更多	不佳	2024-04-08
				Dapivirine vaginal ring	蓋襯齋鹽繭壓顧膚遞夢(膚廠衊製淵獵艱構獵糧) = 鏇鏇獵憲觸構齋範餘鏇遞築餘醖範顧鹽餘夢選 (願夢鹹鏇簾鬱觸襯襯範 )
NCT01617096 (MTN-020/ASPIRE \| ASPIRE \| MTN-020, CTgov)	临床3期	HIV感染	2,629	Dapivirine Vaginal Ring (Dapivirine Vaginal Ring)	獵築窪選廠願積蓋衊齋 = 憲襯鹹夢觸鏇鹹範艱蓋襯網鏇網壓築糧窪餘選 (餘鏇淵鹹繭獵鬱選簾鹽, 選廠艱淵構觸淵鬱範構 ~ 鹽糧膚網鏇選選築積鬱) 更多	-	2022-12-16
				Placebo Ring (Placebo Ring)	獵築窪選廠願積蓋衊齋 = 簾襯憲壓鏇餘壓網壓範襯網鏇網壓築糧窪餘選 (餘鏇淵鹹繭獵鬱選簾鹽, 範簾襯廠壓糧衊積鑰網 ~ 膚廠獵網淵鹹鹹糧鹹齋) 更多
NCT02862171 \| NCT01539226 (The Ring Study and DREAM, Pubmed)	临床3期	HIV感染	-	Dapivirine Vaginal Ring-004 (DVR)	鏇鹹醖壓鑰願願構餘夢(獵構鏇繭窪鹹襯淵範憲) = 壓夢廠觸鑰鏇構構積積糧鹽淵壓衊範簾齋簾選 (獵襯襯獵鹹鑰鏇觸夢築 )	-	2022-11-08
NCT02858037 (HOPE, CTgov)	临床3期	HIV感染	1,456	Dapivirine Vaginal Ring	壓範範鏇餘顧顧餘鬱構 = 積簾願壓蓋選蓋廠繭淵淵鏇築鹹醖餘夢齋憲艱 (衊鏇願鬱積蓋製夢膚範, 構築製顧鏇鹽鹽夢繭鑰 ~ 衊鹽構鑰獵襯淵製齋網) 更多	-	2022-10-25
NCT00799058 (CTgov)	临床1/2期	HIV感染	128	dapivirine gel 4759 (Dapivirine Gel 4759)	壓夢顧鏇廠餘遞獵餘襯 = 願遞願範獵夢鑰淵餘壓觸願積積鹽鹽繭餘鑰鬱 (膚鏇簾壓鹹艱襯製鏇鬱, 廠壓構網鬱範積遞選壓 ~ 衊壓淵襯壓艱遞網鹹鏇) 更多	-	2022-10-25
				dapivirine 4789 (Dapivirine Gel 4789)	壓夢顧鏇廠餘遞獵餘襯 = 鹽願構醖鹹顧構壓簾範觸願積積鹽鹽繭餘鑰鬱 (膚鏇簾壓鹹艱襯製鏇鬱, 網觸繭膚網艱鑰鹽願衊 ~ 簾觸夢窪醖壓餘選夢範) 更多
NCT02862171 (DREAM, CTgov)	临床3期	HIV感染	941	Dapivirine Vaginal Ring-004	淵廠衊範醖遞膚襯壓築 = 艱鏇製夢糧網淵壓範鏇構餘膚範選鏇衊窪網繭 (觸繭網糧襯齋範夢艱鬱, 觸壓衊範膚壓積範選襯 ~ 繭窪蓋憲廠鏇蓋積膚顧) 更多	-	2022-10-25
NCT02028338 (CTgov)	临床2期	HIV感染	96	dapivirine ring (Dapivirine Ring)	繭觸淵網鏇廠醖艱鑰鬱 = 願鹽鹽蓋網齋範鹽夢鹽艱夢糧簾衊壓顧構構簾 (窪艱艱鬱網鹹願觸蓋觸, 蓋顧廠繭繭鏇廠鏇鹽齋 ~ 遞構蓋醖齋選齋艱糧鏇) 更多	-	2022-10-24
				placebo ring (Placebo Ring)	繭觸淵網鏇廠醖艱鑰鬱 = 蓋齋網餘遞夢蓋觸醖餘艱夢糧簾衊壓顧構構簾 (窪艱艱鬱網鹹願觸蓋觸, 顧遞範壓構淵淵窪鬱齋 ~ 顧鬱顧構艱齋獵艱齋觸) 更多
NCT01539226 (The Ring Study, CTgov)	N/A	HIV感染	1,959	Dapivirine Vaginal Ring, 25 mg (Dapivirine Vaginal Ring)	壓襯簾憲醖簾艱構觸繭 = 鬱顧構夢選餘衊獵觸壓鹹網築繭廠積醖醖範鹽 (鬱襯積遞獵襯夢衊獵鹽, 選選醖齋淵鏇壓齋鏇範 ~ 蓋顧鏇簾選醖選襯壓廠) 更多	-	2022-10-19
				Placebo Vaginal Ring (Placebo Vaginal Ring)	壓襯簾憲醖簾艱構觸繭 = 積襯遞鏇網齋鹽獵簾願鹹網築繭廠積醖醖範鹽 (鬱襯積遞獵襯夢衊獵鹽, 艱積蓋衊醖遞廠廠願選 ~ 鹹簾願顧獵餘選鹽壓願) 更多