Undisclosed antiretroviral drug use in a multinational clinical trial (HIV prevention trials network 052)

Jessica M. Fogel; Lei Wang; Teresa L. Parsons; San San Ou; Estelle Piwowar-Manning; Ying Chen; Victor O. Mudhune; Mina C. Hosseinipour; Johnstone Kumwenda; James G. Hakim; Suwat Chariyalertsak; Ravindre Panchia; Ian Sanne; Nagalingeswaran Kumarasamy; Beatriz Grinsztejn; Joseph Makhema; Jose Pilotto; Breno R. Santos; Kenneth H. Mayer; Marybeth McCauley; Theresa Gamble; Namandjé N. Bumpus; Craig W. Hendrix; Myron S. Cohen; Susan H. Eshleman

doi:10.1093/infdis/jit390

Undisclosed antiretroviral drug use in a multinational clinical trial (HIV prevention trials network 052)

Jessica M. Fogel, Lei Wang, Teresa L. Parsons, San San Ou, Estelle Piwowar-Manning, Ying Chen, Victor O. Mudhune, Mina C. Hosseinipour, Johnstone Kumwenda, James G. Hakim, Suwat Chariyalertsak, Ravindre Panchia, Ian Sanne, Nagalingeswaran Kumarasamy, Beatriz Grinsztejn, Joseph Makhema, Jose Pilotto, Breno R. Santos, Kenneth H. Mayer, Marybeth McCauleyTheresa Gamble, Namandjé N. Bumpus, Craig W. Hendrix, Myron S. Cohen, Susan H. Eshleman

School of Medicine

Research output: Contribution to journal › Article › peer-review

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 selfreport of ARV drug use in some clinical trial settings.

Original language	English (US)
Pages (from-to)	1624-1628
Number of pages	5
Journal	Journal of Infectious Diseases
Volume	208
Issue number	10
DOIs	https://doi.org/10.1093/infdis/jit390
State	Published - Nov 15 2013

Keywords

Africa
Antiretroviral drug
Clinical trial
HIV
HPTN 052
Self-report

ASJC Scopus subject areas

Immunology and Allergy
Infectious Diseases

Access to Document

10.1093/infdis/jit390

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Fogel, J. M., Wang, L., Parsons, T. L., Ou, S. S., Piwowar-Manning, E., Chen, Y., Mudhune, V. O., Hosseinipour, M. C., Kumwenda, J., Hakim, J. G., Chariyalertsak, S., Panchia, R., Sanne, I., Kumarasamy, N., Grinsztejn, B., Makhema, J., Pilotto, J., Santos, B. R., Mayer, K. H., ... Eshleman, S. H. (2013). Undisclosed antiretroviral drug use in a multinational clinical trial (HIV prevention trials network 052). Journal of Infectious Diseases, 208(10), 1624-1628. https://doi.org/10.1093/infdis/jit390

Undisclosed antiretroviral drug use in a multinational clinical trial (HIV prevention trials network 052). / 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, Jose; Santos, Breno R.; Mayer, Kenneth H.; McCauley, Marybeth; Gamble, Theresa; Bumpus, Namandjé N.; Hendrix, Craig W.; Cohen, Myron S.; Eshleman, Susan H.

In: Journal of Infectious Diseases, Vol. 208, No. 10, 15.11.2013, p. 1624-1628.

Research output: Contribution to journal › Article › peer-review

Fogel, JM, Wang, L, Parsons, TL, Ou, SS, Piwowar-Manning, E, Chen, Y, Mudhune, VO, Hosseinipour, MC, Kumwenda, J, Hakim, JG, Chariyalertsak, S, Panchia, R, Sanne, I, Kumarasamy, N, Grinsztejn, B, Makhema, J, Pilotto, J, Santos, BR, Mayer, KH, McCauley, M, Gamble, T, Bumpus, NN , Hendrix, CW, Cohen, MS & Eshleman, SH 2013, 'Undisclosed antiretroviral drug use in a multinational clinical trial (HIV prevention trials network 052)', Journal of Infectious Diseases, vol. 208, no. 10, pp. 1624-1628. https://doi.org/10.1093/infdis/jit390

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, Jose ; Santos, Breno R. ; Mayer, Kenneth H. ; McCauley, Marybeth ; Gamble, Theresa ; Bumpus, Namandjé N. ; Hendrix, Craig W. ; Cohen, Myron S. ; Eshleman, Susan H. / Undisclosed antiretroviral drug use in a multinational clinical trial (HIV prevention trials network 052). In: Journal of Infectious Diseases. 2013 ; Vol. 208, No. 10. pp. 1624-1628.

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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 selfreport of ARV drug use in some clinical trial settings.",

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author = "Fogel, {Jessica M.} and Lei Wang and Parsons, {Teresa L.} and Ou, {San San} and Estelle Piwowar-Manning and Ying Chen and Mudhune, {Victor O.} and Hosseinipour, {Mina C.} and Johnstone Kumwenda and Hakim, {James G.} and Suwat Chariyalertsak and Ravindre Panchia and Ian Sanne and Nagalingeswaran Kumarasamy and Beatriz Grinsztejn and Joseph Makhema and Jose Pilotto and Santos, {Breno R.} and Mayer, {Kenneth H.} and Marybeth McCauley and Theresa Gamble and Bumpus, {Namandj{\'e} N.} and Hendrix, {Craig W.} and Cohen, {Myron S.} and Eshleman, {Susan H.}",

note = "Funding Information: Financial support. This work was supported by the Division of AIDS of the US National Institute of Allergy and Infectious Diseases and the Office of AIDS Research of the US National Institutes of Health (grants U01-AI018136, U01-AI068613/UM1-AI068613, U01-AI068617/UM1-AI068617, and U01-AI068619/UM1-AI068619). Study drugs used in HPTN 052 were donated by Abbott Laboratories, Boehringer-Ingelheim Pharmaceuticals, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline/ ViiV Healthcare, and Merck. Potential conflicts of interest. All authors: No reported conflicts.",

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AU - Wang, Lei

AU - Parsons, Teresa L.

AU - Ou, San San

AU - Piwowar-Manning, Estelle

AU - Chen, Ying

AU - Mudhune, Victor O.

AU - Hosseinipour, Mina C.

AU - Kumwenda, Johnstone

AU - Hakim, James G.

AU - Chariyalertsak, Suwat

AU - Panchia, Ravindre

AU - Sanne, Ian

AU - Kumarasamy, Nagalingeswaran

AU - Grinsztejn, Beatriz

AU - Makhema, Joseph

AU - Pilotto, Jose

AU - Santos, Breno R.

AU - Mayer, Kenneth H.

AU - McCauley, Marybeth

AU - Gamble, Theresa

AU - Bumpus, Namandjé N.

AU - Hendrix, Craig W.

AU - Cohen, Myron S.

AU - Eshleman, Susan H.

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