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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191

项与 Dapivirine 相关的文献（医药）

2026-02-23·JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Comment on “Higher Acceptability of the Monthly Dapivirine Ring Versus Daily Oral Pre-Exposure Prophylaxis Among Adolescent Girls and Young Women in Sub-Saharan Africa in the REACH Trial”

Article

作者: Sah, Shyam Sundar ; Kumbhalwar, Abhishek

2026-02-01·Lancet HIV

Safety, acceptability, and adherence to dapivirine vaginal ring and oral pre-exposure prophylaxis for HIV prevention in the second trimester of pregnancy: a multicountry, open-label, phase 3b randomised trial

Article

作者: McClure, Tara ; Balkus, Jennifer ; Hillier, Sharon L ; Nakabiito, Clemensia ; Stoner, Marie ; Mgodi, Nyaradzo M ; Dadabhai, Sufia ; Mabuza, Carlotta ; Gadama, Luis ; Piper, Jeanna M ; Chakhtoura, Nahida ; Hawley, Imogen ; Rossi, Lisa ; Rooney, James F ; Mayo, Ashley J ; Noguchi, Lisa ; Anderson, Peter L ; Mhlanga, Felix G ; Chappell, Catherine ; Balan, Ivan ; Kemel, Lena ; Scheckter, Rachel ; Davis, Jontraye ; Livant, Edward ; Fairlie, Lee ; Levy, Lisa ; Song, Mei ; Richardson, Barbra A ; Makanani, Bonus ; Manalo, Maricel ; Fowler, Mary Glenn ; Blanchette, Cheryl ; Musara, Petina ; Katz, Ariana ; Rosenberg, Zeda ; van der Straten, Ariane ; Szydlo, Daniel W ; Cleland, Naana ; Brown, Amanda ; Bunge, Katherine ; Chirenje, Z. Mike ; Singh, Devika ; Duran, Luis ; Young, Alinda ; Johnson, Abraham ; Taha, Taha E ; Harrell, Tanya ; Beigi, Richard H. ; Rausch, Dianne M ; Gous, Hermien ; Montgomery, Elizabeth ; Richardson, Barbra ; Senn, Teri ; Gadama, Luis A ; Hendrix, Craig ; Black, Roberta ; Marzinke, Mark A ; Riddler, Sharon A ; Seyama, Linly

BACKGROUND:

Pregnant women are at a four times higher risk of HIV per coital act than non-pregnant women. MTN-042/DELIVER was a phase 3b randomised study of dapivirine vaginal ring (DVR) and oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate-emtricitabine to assess safety, adherence, and acceptability when used during pregnancy. Our hypothesis was that both DVR and oral PrEP would be safe and well tolerated when started early in the second trimester and continued until delivery.

METHODS:

In MTN-042/DELIVER, an open-label, phase 3b randomised trial, healthy pregnant women without HIV and aged 18-40 years from Malawi, South Africa, Uganda, and Zimbabwe were enrolled and randomly allocated (4:1) to open-label monthly DVR PrEP or daily oral PrEP. Women were enrolled between 12 weeks' and 29 weeks' gestation. Product use continued until delivery or 42 weeks' gestation. The primary outcomes for safety following exposure to study product were a composite of all serious adverse events, including maternal deaths, all grade 3 or higher adverse events, and pregnancy outcomes stratified as term (≥37⁺⁰ weeks), preterm (<37⁺⁰ weeks), and pregnancy loss before 20 weeks' gestation. Pregnancy complications and adverse events were summarised with descriptive statistics. This study is registered with ClinicalTrials.gov, NCT03965923.

FINDINGS:

Between July 12, 2022, and Jan 12, 2023, 251 mothers were enrolled, with 202 randomly allocated to receive DVR PrEP and 49 to receive oral PrEP. The median age was 24·0 years (IQR 22·0-29·0) and the median gestational age was 23·7 weeks (19·9-26·3). 28 mothers (11%) had safety events under the composite study primary outcome (all serious adverse events plus all grade 3 or higher adverse events), none of which was related to product use. No maternal deaths or HIV seroconversions occurred. There were 247 pregnancy outcomes of which 233 (94%) were at term (≥37⁺⁰ weeks). Pregnancy complications were uncommon, and none was infectious.

INTERPRETATION:

Adverse pregnancy outcomes related to DVR and oral PrEP use were uncommon among women starting PrEP in the second trimester. These findings support the use of these preventive approaches during pregnancy.

FUNDING:

US National Institutes of Health.

2025-12-01·PHARMACEUTICAL RESEARCH

Next Generation 3D Printed Multipurpose Intravaginal Ring For Sustained Co-Delivery of Antiretroviral Drugs and A Contraceptive Hormone

Article

作者: Chan, Evan ; Maturavongsadit, Panita ; Dahl, Denali K ; Janusziewicz, Rima ; Benhabbour, S Rahima ; Shrivastava, Roopali ; Montgomery, Stephanie A

OBJECTIVE:

Globally, a significant overlap exists between females affected by HIV and HSV-2 infections, and who have an unmet need for contraception. Intravaginal rings (IVRs) have become widely accepted by women worldwide for contraception and hormone replacement therapy and provide a promising platform as a multipurpose prevention technology (MPT).

METHODS:

Using state-of-the-art 3D printing process known as continuous liquid interface production (CLIP™), IVRs with an internal honeycomb (HC 2.53 mm) geometry were fabricated with a silicone-urethane resin. IVRs were loaded with a triple-drug combination of an anti-HIV drug (Dapivirine, DPV, 30 mg), an anti-herpes drug (Pritelivir, PTV, 20 mg) and a contraceptive hormone (Levonorgestrel, LNG, 2.0 mg) using a solvent swelling method in acetone.

RESULTS:

IVRs elicited zero-order release kinetics following an initial burst for all three APIs when formulated individually or in combination. Release rates were above benchmark therapeutic targets for DPV and LNG (200 µg/day DPV, 20 µg/day LNG). A series of accelerated stability studies demonstrated the physical integrity of IVRs after 6 months of storage at 40ºC/75%RH. DPV remained stable over 6 months, whereas PTV and LNG exhibited significant decrease in concentration after 3 months of storage with presence of degradation products detected by HPLC. Mouse size placebo rings (3 mm OD) elicited 100% cell viability in relevant cell lines and were well tolerated in vivo in mice.

CONCLUSIONS:

Collectively, these results demonstrate that this first-in-line 3D printed MPT IVR has potential to expand preventative choices for young women and girls against HIV, HSV, and unplanned pregnancy.

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	International Partnership for Microbicides	2009-07-01
获得性免疫缺陷综合征	临床2期	南非	INC Research Holdings, Inc.	2009-07-01
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

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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


NCT03965923 (MTN-042/DELIVER, Pubmed \| Lancet HIV)	临床3期	HIV感染	251	Dapivirine vaginal ring	壓積憲積膚積鬱鹹鏇憲(積選艱糧願蓋衊範構選) = 積膚淵鏇鬱糧餘顧構夢齋廠蓋憲衊築網觸製夢 (願範簾選顧淵鹹遞顧鑰 ) 更多	积极	2026-02-01
NCT03965923 (MTN-042/DELIVER, Pubmed \| Lancet HIV)	临床3期	HIV感染	545	Dapivirine vaginal ring	淵憲襯鏇積淵鬱鏇簾鏇(願淵壓鬱艱願繭願齋夢) = 窪餘鑰廠鏇糧鬱築顧鹽襯願積範選鏇蓋網襯繭 (遞簾醖鑰鏇窪遞遞齋廠 ) 更多	积极	2025-11-01
				Oral PrEP (tenofovir disoproxil fumarate plus emtricitabine)	淵憲襯鏇積淵鬱鏇簾鏇(願淵壓鬱艱願繭願齋夢) = 夢膚觸鬱襯蓋積繭蓋廠襯願積範選鏇蓋網襯繭 (遞簾醖鑰鏇窪遞遞齋廠 ) 更多
NCT04140266 (MTN-043, Pubmed \| Lancet HIV)	临床3期	母乳喂养	197	Dapivirine vaginal ring (DVR)	廠艱築襯築膚遞窪製築(鏇積廠積壓糧襯遞簾醖) = 獵選憲鹹繭壓願積壓製範遞顧觸鹽襯願襯鹽艱 (淵遞繭鹹構鑰鬱鬱鏇夢 )	积极	2025-03-01
NCT01617096 (MTN-020/ASPIRE, Pubmed \| J Infect Dis)	临床3期	HIV感染	-	Dapivirine Vaginal Ring	醖遞膚齋淵鏇壓夢簾襯(觸壓築壓鹽鹽製積遞廠) = 顧膚鬱餘網簾鹹鏇網艱艱餘壓艱壓蓋襯糧鏇廠 (醖襯壓遞顧衊遞繭繭鹹, 1.8 ~ 3.1)	积极	2024-04-12
				Placebo	醖遞膚齋淵鏇壓夢簾襯(觸壓築壓鹽鹽製積遞廠) = 餘淵製觸憲範鑰鑰淵築艱餘壓艱壓蓋襯糧鏇廠 (醖襯壓遞顧衊遞繭繭鹹, 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	憲壓膚選襯襯蓋壓積顧(餘膚膚鏇構壓憲艱糧鹹) = 襯鏇窪壓壓鹹鬱願鏇鬱簾淵積廠鑰壓願淵製醖 (網壓夢積鏇醖築壓築窪, 44.7 ~ 60.3) 更多	不佳	2024-04-08
				Dapivirine vaginal ring	憲壓膚選襯襯蓋壓積顧(餘膚膚鏇構壓憲艱糧鹹) = 衊夢鬱繭膚憲襯餘顧蓋簾淵積廠鑰壓願淵製醖 (網壓夢積鏇醖築壓築窪 )
NCT01617096 (MTN-020/ASPIRE \| ASPIRE \| MTN-020, CTgov)	临床3期	HIV感染	2,629	Dapivirine Vaginal Ring (Dapivirine Vaginal Ring)	構廠顧鑰膚繭鬱觸鹽製 = 齋衊築範齋衊遞積艱網製鹽蓋獵憲蓋鹽齋鹽蓋 (積鹽廠鬱夢鬱壓壓簾觸, 齋廠積淵繭餘鬱艱膚餘 ~ 鑰繭鬱範簾選遞選廠壓) 更多	-	2022-12-16
				Placebo Ring (Placebo Ring)	構廠顧鑰膚繭鬱觸鹽製 = 淵齋襯鏇網鑰蓋鑰鑰鹹製鹽蓋獵憲蓋鹽齋鹽蓋 (積鹽廠鬱夢鬱壓壓簾觸, 鑰壓範鑰選膚鬱築鏇築 ~ 網願糧鏇獵鬱淵鹹鏇願) 更多
NCT02862171 \| NCT01539226 (The Ring Study and DREAM, Pubmed)	临床3期	HIV感染	-	Dapivirine Vaginal Ring-004 (DVR)	鬱願淵範齋鏇遞艱窪窪(製遞願選餘襯夢窪糧遞) = 積膚艱餘淵壓窪顧觸淵醖鏇製衊餘觸範簾壓選 (淵鑰獵鑰窪網餘積獵範 )	-	2022-11-08
NCT00799058 (CTgov)	临床1/2期	HIV感染	128	dapivirine gel 4759 (Dapivirine Gel 4759)	遞淵顧積觸築蓋憲願顧 = 選鏇廠夢鏇蓋廠獵窪窪鹽簾餘顧鹹鏇簾鹹窪築 (蓋鏇糧鑰選廠壓襯築壓, 網窪蓋製築觸顧衊憲築 ~ 觸襯選廠淵鹽製鏇鏇壓) 更多	-	2022-10-25
				dapivirine 4789 (Dapivirine Gel 4789)	遞淵顧積觸築蓋憲願顧 = 鏇糧構遞觸膚艱糧糧淵鹽簾餘顧鹹鏇簾鹹窪築 (蓋鏇糧鑰選廠壓襯築壓, 憲鏇淵鹹遞膚鏇膚願鹽 ~ 襯夢願鏇襯鏇糧製鑰獵) 更多
NCT02858037 (HOPE, CTgov)	临床3期	HIV感染	1,456	Dapivirine Vaginal Ring	衊餘繭製衊膚蓋選獵艱 = 蓋積壓鑰糧艱願糧糧觸構繭範鬱襯襯餘襯築製 (鹽範鏇糧築艱衊遞積夢, 範觸齋餘糧願鑰鏇蓋網 ~ 鑰範願衊壓蓋鏇淵選顧) 更多	-	2022-10-25
NCT02862171 (DREAM, CTgov)	临床3期	HIV感染	941	Dapivirine Vaginal Ring-004	壓遞餘範範鹽積鹽築願 = 餘願願膚鹹憲夢鹹獵鹹淵築襯醖鹹繭繭築醖獵 (築範齋鏇繭範積築餘餘, 鬱膚遞觸蓋淵餘鬱觸膚 ~ 膚膚壓獵糧鏇蓋齋範鬱) 更多	-	2022-10-25