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UNDISCLOSED ANTIRETROVIRAL DRUG USE IN A MULTINATIONAL CLINICAL TRIAL (HIV PREVENTION TRIALS NETWORK 052)
0022-1899
Author
Fogel, Jessica M.
Wang, Lei
Parsons, Teresa L.
Ou, San-San
Piwowar-Manning, Estelle
Chen, Ying
Mudhune, Victor O.
Hosseinipour, Mina C.
Kumwenda, Johnstone
Hakim, James G.
Chariyalertsak, Suwat
Panchia, Ravindre
Sanne, Ian
Kumarasamy, Nagalingeswaran
Grinsztejn, Beatriz
Makhema, Joseph
Pilotto, José
Santos, Breno R.
Mayer, Kenneth H.
McCauley, Marybeth
Gamble, Theresa
Bumpus, Namandjé N.
Hendrix, Craig W.
Cohen, Myron S.
Eshleman, Susan H.
Wang, Lei
Parsons, Teresa L.
Ou, San-San
Piwowar-Manning, Estelle
Chen, Ying
Mudhune, Victor O.
Hosseinipour, Mina C.
Kumwenda, Johnstone
Hakim, James G.
Chariyalertsak, Suwat
Panchia, Ravindre
Sanne, Ian
Kumarasamy, Nagalingeswaran
Grinsztejn, Beatriz
Makhema, Joseph
Pilotto, José
Santos, Breno R.
Mayer, Kenneth H.
McCauley, Marybeth
Gamble, Theresa
Bumpus, Namandjé N.
Hendrix, Craig W.
Cohen, Myron S.
Eshleman, Susan H.
Affilliation
Johns Hopkins University. School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, Washington, USA.
Johns Hopkins University. School of Medicine. Department of Medicine. Baltimore, Maryland, USA.
Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, Washington, USA.
Johns Hopkins University. School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, Washington, USA.
KEMRI-CDC HIV Research Branch. Kisumu, Kenya.
UNC Project. Kamuzu Central Hospital. Lilongwe. Malawi.
College of Medicine. Blantyre, Malawi.
University of Zimbabwe. Department of Medicine. Harare. Zimbabwe.
Chiang Mai University. Research Institute for Health Sciences. Thailand.
University of the Witwatersrand. Faculty of Health Sciences. Department of Medicine. Perinatal HIV Research Unit. Johannesburg, South Africa.
University of the Witwatersrand. Faculty of Health Sciences. Department of Medicine. Clinical HIV Research Unit. Johannesburg, South Africa.
Y. R. Gaitonade Center for AIDS Research and Education, Chennai, India.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Laboratorio de Pesquisa Clinica em DST/AIDS . Rio de Janeiro, RJ, Brasil.
19Botswana– Harvard School of Public Health AIDS Initiative Partnership, Gaborone.
Fundação Oswaldo Cruz. Instituto Oswaldo cruz. Laboratório de AIDS e Imunologia Molecular. Rio de Janeiro, RJ, Brasil / Hospital Geral de Nova Iguaçu. Nova Iguaçu, RJ, Brasil.
Hospital Nossa Senhora da Conceicao. Porto Alegre, RS, Brasil.
Fenway Health. Boston, Massachusetts, USA.
FHI360. Washington, District of Columbia, USA.
FHI360. Durham, North Carolin, USA.
Johns Hopkins University. School of Medicine. Department of Medicine. Baltimore, Maryland, USA.
Johns Hopkins University. School of Medicine. Department of Medicine. Baltimore, Maryland, USA.
University of North Carolina. Department of Medicine. Chapel Hill, NC, USA.
Johns Hopkins University. School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, Washington, USA.
Johns Hopkins University. School of Medicine. Department of Medicine. Baltimore, Maryland, USA.
Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, Washington, USA.
Johns Hopkins University. School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Fred Hutchinson Cancer Research Center. Vaccine and Infectious Disease Division. Seattle, Washington, USA.
KEMRI-CDC HIV Research Branch. Kisumu, Kenya.
UNC Project. Kamuzu Central Hospital. Lilongwe. Malawi.
College of Medicine. Blantyre, Malawi.
University of Zimbabwe. Department of Medicine. Harare. Zimbabwe.
Chiang Mai University. Research Institute for Health Sciences. Thailand.
University of the Witwatersrand. Faculty of Health Sciences. Department of Medicine. Perinatal HIV Research Unit. Johannesburg, South Africa.
University of the Witwatersrand. Faculty of Health Sciences. Department of Medicine. Clinical HIV Research Unit. Johannesburg, South Africa.
Y. R. Gaitonade Center for AIDS Research and Education, Chennai, India.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Laboratorio de Pesquisa Clinica em DST/AIDS . Rio de Janeiro, RJ, Brasil.
19Botswana– Harvard School of Public Health AIDS Initiative Partnership, Gaborone.
Fundação Oswaldo Cruz. Instituto Oswaldo cruz. Laboratório de AIDS e Imunologia Molecular. Rio de Janeiro, RJ, Brasil / Hospital Geral de Nova Iguaçu. Nova Iguaçu, RJ, Brasil.
Hospital Nossa Senhora da Conceicao. Porto Alegre, RS, Brasil.
Fenway Health. Boston, Massachusetts, USA.
FHI360. Washington, District of Columbia, USA.
FHI360. Durham, North Carolin, USA.
Johns Hopkins University. School of Medicine. Department of Medicine. Baltimore, Maryland, USA.
Johns Hopkins University. School of Medicine. Department of Medicine. Baltimore, Maryland, USA.
University of North Carolina. Department of Medicine. Chapel Hill, NC, USA.
Johns Hopkins University. School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Abstract
The HIV Prevention Trials Network 052 study enrolled serodiscordant couples. Index participants infected with human immunodeficiency virus reported no prior antiretroviral (ARV) treatment at enrollment. ARV drug testing was performed retrospectively using enrollment samples from a subset of index participants. ARV drugs were detected in 45 of 96 participants (46.9%) with an undetectable viral load, 2 of 48 (4.2%) with a low viral load, and 1 of 65 (1.5%) with a high viral load (P < .0001); they were also detected in follow-up samples from participants who were not receiving study-administered treatment. ARV drug testing may be useful in addition to self-report of ARV drug use in some clinical trial settings.
Publisher
Oxford University Press
Citation
FOGEL, Jessica M.; et al. Undisclosed Antiretroviral Drug Use in a Multinational Clinical Trial (HIV Prevention Trials Network 052). J Infect Dis., v.208, n.10, p.1624-1628, 2013.DOI
10.1093/infdis/jit390ISSN
1537-66130022-1899
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