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2019-12-08
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SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF LONG-ACTING INJECTABLE CABOTEGRAVIR IN LOW-RISK HIV-UNINFECTED INDIVIDUALS: HPTN 077, A PHASE 2A RANDOMIZED CONTROLLED TRIAL
Landovitz, Raphael J et al. | Date Issued: 2018
Author
Landovitz, Raphael J
Li, Sue
Grinsztejn, Beatriz
Dawood, Halima
Liu, Albert Y
Magnus, Manya
Hosseinipour, Mina C
Panchia, Ravindre
Cottle, Leslie
Chau, Gordon
Richardson, Paul
Marzinke, Mark A
Hendrix, Craig W
Eshleman, Susan H
Zhang, Yinfeng
Tolley, Elizabeth
Sugarman, Jeremy
Kofron, Ryan
Adeyeye, Adeola
Burns, David
Rinehart, Alex R
Margolis, David
Spreen, William R
Cohen, Myron S
McCauley, Marybeth
Eron, Joseph J
Affilliation
UCLA Center for Clinical AIDS Research and Education. Los Angeles, California, United States of America.
Statistical Center for HIV/AIDS Research and Prevention. Fred Hutchinson Cancer Research Center. Seattle, Washington, United States of America.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
University of KwaZulu Natal. Centre for the AIDS Programme of Research in South Africa. Durban, South Africa.
Bridge HIV. Population Health Division. San Francisco Department of Health. San Francisco, California, United States of America.
George Washington University. Milken Institute School of Public Health. Department of Epidemiology and Biostatistics. Washington, District of Columbia, United States of America.
UNC Project-Malawi. Lilongwe, Malawi.
Chris Hani Baragwanath Hospital. Perinatal HIV Research Unit. Soweto, South Africa.
Statistical Center for HIV/AIDS Research and Prevention. Fred Hutchinson Cancer Research Center. Seattle, Washington, United States of America.
Statistical Center for HIV/AIDS Research and Prevention. Fred Hutchinson Cancer Research Center. Seattle, Washington, United States of America.
Johns Hopkins University. School of Medicine. Baltimore, Maryland, United States of America.
Johns Hopkins University. School of Medicine. Baltimore, Maryland, United States of America.
Johns Hopkins University. School of Medicine. Baltimore, Maryland, United States of America.
Johns Hopkins University. School of Medicine. Baltimore, Maryland, United States of America.
Johns Hopkins University. School of Medicine. Baltimore, Maryland, United States of America.
FHI360. Durham, North Carolina, United States of America.
Johns Hopkins University. Berman Institute of Bioethics. Baltimore, Maryland, United States of America./ Johns Hopkins University. School of Medicine. Baltimore, Maryland, United States of America.
UCLA Center for Clinical AIDS Research and Education. Los Angeles, California, United States of America.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Division of AIDS. Rockville, Maryland, United States of America.
National Institutes of Health. National Institute of Allergy and Infectious Diseases. Division of AIDS. Rockville, Maryland, United States of America.
ViiV Healthcare. Durham, North Carolina, United States of America.
ViiV Healthcare. Durham, North Carolina, United States of America.
ViiV Healthcare. Durham, North Carolina, United States of America.
FHI360. Durham, North Carolina, United States of America.
University of North Carolina at Chapel Hill. Chapel Hill, North Carolina, United States of America.
Abstract
Cabotegravir (CAB) is a novel strand-transfer integrase inhibitor being developed for HIV treatment and prevention. CAB is formulated both as an immediate-release oral tablet for daily administration and as a long-acting injectable suspension (long-acting CAB [CAB LA]) for intramuscular (IM) administration, which delivers prolonged plasma exposure to the drug after IM injection. HIV Prevention Trials Network study 077 (HPTN 077) evaluated the safety, tolerability, and pharmacokinetics of CAB LA in HIV-uninfected males and females at 8 sites in Brazil, Malawi, South Africa, and the United States.
Keywords
Cabotegravir
HPTN
HIV-uninfected
HIV treatment
HIV prevention
 
Publisher
Public Library of Science
Citation
LANDOVITZ, R. J. et al. Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial. PLoS medicine, v. 15, n. 11, p. e1002690, 2018.
DOI
10.1371/journal.pmed.1002690
ISSN
1549-1277