A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety, and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults (MTN-026)-Reference-Cited by-同舟云学术

A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety, and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults (MTN-026)

Published:2021-12-06 Issue: Volume: Page:
ISSN:0889-2229
Container-title:AIDS Research and Human Retroviruses
language:en
Short-container-title:AIDS Research and Human Retroviruses

Author:

Cranston Ross D.¹^ORCID,Brown Elizabeth²,Bauermeister José³,Dunne Eileen F.⁴⁵,Hoesley Craig⁶,Ho Ken⁷,Johnson Sherri⁸,Lucas Jonathan⁸,Dominguez-Islas Clara²,Gundacker Holly⁹,Peda Melissa⁹,Jacobson Cindy E.¹⁰,Kramzer Lindsay¹⁰,Singh Devika¹⁰,Dezzutti Charlene S.⁷¹⁰,Kunjara Na Ayudhya Ratiya Pamela¹⁰,Brand Rhonda M.⁷,Wang Lin¹¹,Marzinke Mark A.¹²,Piper Jeanna¹³,Devlin Bríd¹⁴,Nuttall Jeremy¹⁴,McGowan Ian⁷,Hendrix Craig W.¹²,

Affiliation:

1. Department of Medicine, University of Barcelona, Barcelona, Spain.

2. Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.

3. Department of Family and Community Health, University of Pennsylvania, Pennsylvania, Philadelphia, USA.

4. Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA.

5. Thailand Ministry of Public Health-US CDC Collaboration, Bangkok, Thailand.

6. Department of Medical Education, University of Alabama at Birmingham, Birmingham, Alabama, USA.

7. Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

8. FHI 360, Durham, North Carolina, USA.

9. Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.

10. Microbicide Trials Network, Pittsburgh, Pennsylvania, USA.

11. Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

12. Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

13. Division of AIDS/NIAID/NIH, Bethesda, Maryland, USA.

14. International Partnership for Microbicides, Silver Spring, Maryland, USA.

Publisher

Mary Ann Liebert Inc

Subject

Infectious Diseases,Virology,Immunology

Link

https://www.liebertpub.com/doi/pdf/10.1089/aid.2021.0071

Reference22 articles.

1. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial

2. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection

3. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial

4. Effectiveness and Safety of Tenofovir Gel, an Antiretroviral Microbicide, for the Prevention of HIV Infection in Women

5. A safety and pharmacokinetic trial assessing delivery of dapivirine from a vaginal ring in healthy women

Cited by 5 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. A Phase 1 Clinical Trial to Assess the Safety and Pharmacokinetics of a Tenofovir Alafenamide/Elvitegravir Insert Administered Rectally for HIV Prevention;The Journal of Infectious Diseases;2024-04-24

2. Hypo-osmolar rectal douche tenofovir formulation prevents simian/human immunodeficiency virus acquisition in macaques;JCI Insight;2022-12-08

3. MTN-033: a Phase 1 Study Comparing Applicator versus “as Lubricant” Delivery of Rectal Dapivirine Gel;Antimicrobial Agents and Chemotherapy;2022-11-15

4. The need for more holistic immune profiling in next-generation SARS-CoV-2 vaccine trials;Frontiers in Immunology;2022-09-20

5. Cellular Immunity Is Critical for Assessing COVID-19 Vaccine Effectiveness in Immunocompromised Individuals;Frontiers in Immunology;2022-05-26