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.

Start Date27 Feb 2024

Sponsor / Collaborator-

NCT06807736

/ RecruitingNot ApplicableIIT

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.

Start Date13 Feb 2024

Sponsor / Collaborator

Desmond Tutu Hiv Foundation

[+2]

NCT05416021

/ CompletedPhase 1

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

Start Date01 Aug 2022

Sponsor / Collaborator

INC Research Holdings, Inc.

100 Clinical Results associated with Dapivirine

100 Translational Medicine associated with Dapivirine

100 Patents (Medical) associated with Dapivirine

389

Literatures (Medical) associated with Dapivirine

01 Jul 2025·Journal of the International AIDS Society

“People have options”: a qualitative study of experiences and influences of PrEP choice among women in South Africa

Article

Author: Mullick, Saiqa ; Kutywayo, Alison ; Martin, Catherine Elizabeth ; Butler, Vusile ; Dada, Siphokazi ; Pleaner, Melanie ; Cholo, Fatima Abegail ; Musvipwa, Faith Mary

Abstract:

Introduction:

Long‐acting injectable cabotegravir and dapivirine vaginal ring were recently introduced in South Africa through demonstration projects, providing additional HIV prevention options to oral pre‐exposure prophylaxis (PrEP). PrEP choice marks a pivotal moment in HIV prevention, potentially increasing PrEP uptake and use by offering women a choice of methods best suited to their individual needs. Understanding experiences of PrEP choice in real‐world settings is critical to informing the introduction of PrEP choice at scale. This study, embedded within an implementation science study introducing new PrEP methods, explores women's experiences of PrEP choice counselling, and factors influencing PrEP choice.

Methods:

Between April and May 2024, we conducted 12 focus group discussions with a sub‐set of 126 women (18–57 years) enrolled in a parent cohort study delivering PrEP choice at six fixed and three roving mobile clinics in three areas of South Africa. Cohort participants are HIV‐negative men and women ≥ 15 years interested in HIV prevention services. At the time of data collection, non‐pregnant and lactating women ≥ 18 years enrolled in the cohort were provided PrEP choice counselling and offered a choice of oral PrEP or dapivirine vaginal ring. Discussions explored women's experiences of PrEP choice counselling and influences of PrEP choice. They were audio recorded, transcribed verbatim and translated into English for thematic analysis.

Results:

Women reported positive choice counselling experiences, particularly when it was supplemented by pamphlets, demonstration rings and pelvic models. Participants valued learning about alternative PrEP methods and appreciated friendly healthcare providers who answered their questions. Privacy and emotional support were also crucial. However, negative experiences included the use of complex scientific jargon and insufficient information on PrEP's potential drawbacks. PrEP choices were mainly influenced by concerns about intravaginal products, distrust of new methods, prior oral PrEP experiences, and partner and family opinions.

Conclusions:

These findings will guide strategies for PrEP delivery, emphasizing provider training, effective counselling tools and tailored communication. Women valued clear, jargon‐free information, visual aids and a welcoming environment, which supported open dialogue. The influence of prior oral PrEP experiences on PrEP choice highlights the need for counselling that addresses specific concerns and preferences.

01 Jul 2025·Journal of the International AIDS Society

User and healthcare provider early experiences with the PrEP ring: a quantitative study on the introduction of a new PrEP method in Eswatini

Article

Author: Matse, Sindy Nana ; Khanyile, Nolwazi ; Gama, Ncediso ; Sisel, Haley ; Shongwe, Siphesihle ; Mahlalela, Buyile ; Khumalo, Mxolisi ; Peterson, Jill M. ; Hettema, Anita

Abstract:

Introduction:

Eswatini prepared for the national rollout of HIV pre‐exposure prophylaxis (PrEP) choice through a mixed‐method demonstration study introducing the PrEP dapivirine vaginal ring in 12 Ministry of Health‐supported sites. The Eswatini PrEP Ring Study aimed to describe user preferences for, and experiences with, the PrEP ring, and provider impressions. The objective was to provide real‐world data on client preferences and experiences related to PrEP choice, and healthcare provider perspectives on the feasibility and acceptability of offering PrEP choice. A subset of quantitative findings is presented here.

Methods:

During May 2023–August 2024, 12 study sites in Eswatini began offering a choice between the PrEP ring and oral PrEP to women 18 years and older who were HIV negative, not pregnant or breastfeeding, and interested in PrEP. Current oral PrEP users who were satisfied with the method were not recruited. Users’ early experiences with the PrEP ring were assessed through structured enrolment and follow‐up questionnaires. Factors associated with choosing the PrEP ring at enrolment were assessed using logistic regression. During the first 2 months of offering PrEP choice, providers (n = 16) completed a structured questionnaire on the feasibility and acceptability of PrEP choice service delivery. Clinical Trial Number: NCT05889533

Results:

At enrolment, 69% (n = 625/904) chose the PrEP ring. Predictors for choosing the ring included ages 25+ (25–34 years AOR = 1.44, 95% CI [1.03, 2.02]; ages 35+ years AOR = 1.69, 95% CI [1.07, 2.68]), higher education (AOR = 1.71 for some/completed high school, 95% CI [1.20, 2.43]; AOR = 1.87 for vocational/tertiary education, 95% CI [1.21, 2.90]) and using either longer‐acting (AOR = 2.23, 95% CI [1.28, 3.89]) or shorter‐acting contraceptives (AOR = 1.63, 95% CI [1.14, 2.32]) versus no modern family planning method. Participants reported high levels of ease and confidence (98%) in using the ring. Ninety‐four percent of PrEP counsellors (n = 8) and nurses (n = 8) felt prepared to offer PrEP choice and liked choice counselling but had concerns about clients’ ability to return on time for refills of either method.

Conclusions:

Many women in Eswatini were willing to try the PrEP ring. Providers were enthusiastic about counselling on PrEP choice and introducing women to the ring.

01 Jul 2025·Journal of the International AIDS Society

PrEP preferences and early acceptability of injectable cabotegravir among pregnant and lactating people in Cape Town, South Africa: findings from the PrEPared to Choose study

Article

Author: Hoffman, Risa ; Leonard, Bryan ; Wara, Nafisa ; Lebelo, Keitumetse ; Mapukata, Pakama ; Davey, Dvora Joseph ; Rousseau, Elzette ; Bekker, Linda‐Gail ; Orrell, Catherine ; Macdonald, Pippa ; Pike, Carey

Abstract:

Introduction:

Providing pregnant and lactating people (PLP) with choice in HIV pre‐exposure prophylaxis (PrEP) methods, including long‐acting injectable cabotegravir (CAB‐LA), may mitigate barriers to effective PrEP use. We evaluated PrEP preferences and acceptability among PLP offered CAB‐LA versus oral PrEP in South Africa.

Methods:

The PrEPared to Choose study in Cape Town, South Africa, enrolled young people ages 15–29 at one public clinic and one community‐based mobile clinic. Using informed choice counselling, participants were offered oral PrEP or CAB‐LA, with the option to switch methods at follow‐up visits over 18 months. We report baseline CAB‐LA and oral PrEP initiations among PLP in the study, acceptability of their initial choice within 3 months of enrolment and theoretical preferences regarding PrEP methods that may become available to PLP. We report descriptive statistics and use Chi‐square and Fisher's exact to compare responses by initiated PrEP method and pregnancy status.

Results:

From February to August 2024, we enrolled 58 PLP (n = 30 pregnant, n = 28 breastfeeding). Median age 23 years (IQR 19.5−26). Of 30 pregnant participants, 23 (77%) initiated CAB‐LA and seven (23%) oral PrEP; among 28 breastfeeding participants, 25 (89%) initiated CAB‐LA and three (11%) oral PrEP. Of enrolled PLP, 36 (62%, n = 13 pregnant, n = 23 breastfeeding) completed the acceptability survey. Of these, 83% (n = 12/13 pregnant, n = 20/23 breastfeeding) chose and received CAB‐LA, and the remaining (n = 4) chose and received oral PrEP. PLP who received CAB‐LA reported liking its ease of use (69%; n = 22/32) and long‐acting protection (44%; n = 14/32). Half of CAB‐LA users disliked side effects (e.g. injection site pain), although 41% of PLP (n = 13/32) described no CAB‐LA dislikes. Almost all (97%; n = 31/32) PLP currently using CAB‐LA were interested in continuing CAB‐LA, and all PLP using oral PrEP reported interest in trying CAB‐LA in the future. Eighty‐six percent of surveyed PLP (n = 31/36) did not want to try the dapivirine vaginal ring.

Conclusions:

PLP in South Africa had a strong preference for CAB‐LA over oral PrEP, and CAB‐LA was found to be highly acceptable. Further research is needed to evaluate the effect of offering choice of PrEP methods, including CAB‐LA, on PrEP continuation among PLP.

News (Medical) associated with Dapivirine

18 Jan 2023

·pipelinereview.com

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

VaccinePhase 2Phase 3Clinical Result

18 Jan 2023

·www.jnj.com

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.

VaccinePhase 2Phase 3Clinical Result

100 Deals associated with Dapivirine

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 3	Kenya	INC Research Holdings, Inc.	01 Jul 2011
HIV Infections	Phase 3	Kenya	International Partnership for Microbicides	01 Jul 2011
HIV Infections	Phase 3	Malawi	INC Research Holdings, Inc.	01 Jul 2011
HIV Infections	Phase 3	Rwanda	INC Research Holdings, Inc.	01 Jul 2011
HIV Infections	Phase 3	Rwanda	International Partnership for Microbicides	01 Jul 2011
HIV Infections	Phase 3	South Africa	INC Research Holdings, Inc.	01 Jul 2011
HIV Infections	Phase 3	Zimbabwe	INC Research Holdings, Inc.	01 Jul 2011
Acquired Immunodeficiency Syndrome	Phase 2	South Africa	INC Research Holdings, Inc.	01 Jul 2009
Acquired Immunodeficiency Syndrome	Phase 2	South Africa	International Partnership for Microbicides	01 Jul 2009
Contraception	Phase 1	United States	International Partnership for Microbicides	17 Jul 2018

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04140266 (MTN-043, Pubmed \| Lancet HIV)	Phase 3	Breast Feeding	197	Dapivirine vaginal ring (DVR)	nfwtwxjxzm(mxcbggtnnv) = yvoteyqxut enwrcjbeuv (phqlbmawbz )	Positive	01 Mar 2025
NCT01617096 (MTN-020/ASPIRE, Pubmed \| J Infect Dis)	Phase 3	HIV Infections	-	Dapivirine Vaginal Ring	wrnbxxxqje(kztrcexhzz) = qrncuiugbz oynqijbnzx (qvvceibwwo, 1.8 - 3.1)	Positive	12 Apr 2024
				Placebo	wrnbxxxqje(kztrcexhzz) = llagxdjtgo oynqijbnzx (qvvceibwwo, 2.9 - 4.4)
NCT01539226 (The Ring Study, Pubmed \| BMJ Open) Manual	Not Applicable	HIV Infections	197	Dapivirine vaginal ring / placebo vaginal ring	ccqbkywptl(zdyhpcrgoh) = drmqcejpln swnwbwjyug (kzxstcmdov, 44.7 - 60.3) View more	Negative	08 Apr 2024
				Dapivirine vaginal ring	ccqbkywptl(zdyhpcrgoh) = gcdcgmuthv swnwbwjyug (kzxstcmdov )
NCT01617096 (MTN-020/ASPIRE \| ASPIRE \| MTN-020, CTgov)	Phase 3	HIV Infections	2,629	Dapivirine Vaginal Ring (Dapivirine Vaginal Ring)	xkskmpsdcv = uzhqfrlljh nrdhlcjijz (kwungtsckj, jdccildzdq - dcfdxumhqg) View more	-	16 Dec 2022
				Placebo Ring (Placebo Ring)	xkskmpsdcv = wktjechcis nrdhlcjijz (kwungtsckj, mnikmiqebd - ispskryvtq) View more
NCT02862171 \| NCT01539226 (The Ring Study and DREAM, Pubmed)	Phase 3	HIV Infections	-	Dapivirine Vaginal Ring-004 (DVR)	dbbiegiytu(owjdipovqx) = byuldddttz zjlmkwobjj (hgkomghmeb )	-	08 Nov 2022
NCT02862171 (DREAM, CTgov)	Phase 3	HIV Infections	941	Dapivirine Vaginal Ring-004	dhujxsgjvk = njymmkpbmw ukmbngdpkf (mayyumvbej, swqcvbtzrr - gfewbfeoia) View more	-	25 Oct 2022
NCT02858037 (HOPE, CTgov)	Phase 3	HIV Infections	1,456	Dapivirine Vaginal Ring	giomyaddqk = aothfevsnh jmfqcsafmm (ygjrgzauio, rmkxxiupup - gltpnhoxiu) View more	-	25 Oct 2022
NCT00799058 (CTgov)	Phase 1/2	HIV Infections	128	dapivirine gel 4759 (Dapivirine Gel 4759)	apsavpxpqd = gigefsqtub zzlclrvrtv (jpvkpfuwnn, csycwhyxft - gusqmyloha) View more	-	25 Oct 2022
				dapivirine 4789 (Dapivirine Gel 4789)	apsavpxpqd = lnehpxvgue zzlclrvrtv (jpvkpfuwnn, nxncxpprtm - saxqbymeeq) View more
NCT02028338 (CTgov)	Phase 2	HIV Infections	96	dapivirine ring (Dapivirine Ring)	culcyqkpga = ziepswwmgr ywxjunlpda (ftbwjtfjeg, vydyqmvwdq - qbxghfsgqk) View more	-	24 Oct 2022
				placebo ring (Placebo Ring)	culcyqkpga = ffjfyyzxvs ywxjunlpda (ftbwjtfjeg, pmhwiduzme - hibazgbzyt) View more
NCT01539226 (The Ring Study, CTgov)	Not Applicable	HIV Infections	1,959	Dapivirine Vaginal Ring, 25 mg (Dapivirine Vaginal Ring)	ftuxlvwnqh = nnmuiljvms bhhptabfap (xbfafcfzse, alkcshssck - crkqqyuidc) View more	-	19 Oct 2022
				Placebo Vaginal Ring (Placebo Vaginal Ring)	ftuxlvwnqh = qsdrqbyhzx bhhptabfap (xbfafcfzse, meimzfmefg - nyvazhtdnd) View more

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Dapivirine

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation