Title |
First Phase 1 Double-Blind, Placebo-Controlled, Randomized Rectal Microbicide Trial Using UC781 Gel with a Novel Index of Ex Vivo Efficacy
|
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Published in |
PLOS ONE, September 2011
|
DOI | 10.1371/journal.pone.0023243 |
Pubmed ID | |
Authors |
Peter A. Anton, Terry Saunders, Julie Elliott, Elena Khanukhova, Robert Dennis, Amy Adler, Galen Cortina, Karen Tanner, John Boscardin, William G. Cumberland, Ying Zhou, Ana Ventuneac, Alex Carballo-Diéguez, Lorna Rabe, Timothy McCormick, Henry Gabelnick, Christine Mauck, Ian McGowan |
Abstract |
Successful control of the HIV/AIDS pandemic requires reduction of HIV-1 transmission at sexually-exposed mucosae. No prevention studies of the higher-risk rectal compartment exist. We report the first-in-field Phase 1 trial of a rectally-applied, vaginally-formulated microbicide gel with the RT-inhibitor UC781 measuring clinical and mucosal safety, acceptability and plasma drug levels. A first-in-Phase 1 assessment of preliminary pharmacodynamics was included by measuring changes in ex vivo HIV-1 suppression in rectal biopsy tissue after exposure to product in vivo. |
X Demographics
Geographical breakdown
Country | Count | As % |
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United States | 1 | 33% |
Switzerland | 1 | 33% |
Unknown | 1 | 33% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 2 | 67% |
Science communicators (journalists, bloggers, editors) | 1 | 33% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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United States | 1 | 2% |
Portugal | 1 | 2% |
Unknown | 56 | 97% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 13 | 22% |
Professor > Associate Professor | 8 | 14% |
Student > Master | 8 | 14% |
Student > Ph. D. Student | 5 | 9% |
Student > Bachelor | 4 | 7% |
Other | 12 | 21% |
Unknown | 8 | 14% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 16 | 28% |
Agricultural and Biological Sciences | 9 | 16% |
Pharmacology, Toxicology and Pharmaceutical Science | 5 | 9% |
Social Sciences | 4 | 7% |
Immunology and Microbiology | 3 | 5% |
Other | 10 | 17% |
Unknown | 11 | 19% |