Dataset Information

Undisclosed antiretroviral drug use in a multinational clinical trial (HIV Prevention Trials Network 052).

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.

SUBMITTER: Fogel JM

PROVIDER: S-EPMC3805242 | biostudies-other | 2013 Nov

REPOSITORIES: biostudies-other

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Undisclosed antiretroviral drug use in a multinational clinical trial (HIV Prevention Trials Network 052).

Fogel Jessica M JM Wang Lei L Parsons Teresa L TL Ou San-San SS Piwowar-Manning Estelle E Chen Ying Y Mudhune Victor O VO Hosseinipour Mina C MC Kumwenda Johnstone J Hakim James G JG Chariyalertsak Suwat S Panchia Ravindre R Sanne Ian I Kumarasamy Nagalingeswaran N Grinsztejn Beatriz B Makhema Joseph J Pilotto Jose J Santos Breno R BR Mayer Kenneth H KH McCauley Marybeth M Gamble Theresa T Bumpus Namandjé N NN Hendrix Craig W CW Cohen Myron S MS Eshleman Susan H SH

The Journal of infectious diseases 20130801 10

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 ...[more]

PMID: 23908493

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Project description:Obtaining the definitive data necessary to determine the safety and efficacy of using antiretroviral treatment (ART) to reduce the sexual transmission of HIV in heterosexual couples encountered an array of ethical challenges that threatened to compromise HIV Prevention Trials Network (HPTN) 052, the multinational clinical trial addressing this issue that has profound public health implications.To describe and analyze the major ethical challenges faced in HPTN 052.The ethical issues and modifications of HPTN 052 in response to these issues were cataloged by the principal investigator, the lead coordinator, and the ethicist working on the trial. The major ethical issues that were unique to the trial were then described and analyzed in light of the published literature as well as guidances and policies. The ethical challenges that must be addressed in many clinical trials, such as those related to obtaining informed consent and making provisions for ancillary care, are not described.When HPTN 052 was being designed, ethical questions emerged related to the relevance of the research question itself given data from observational research and a range of beliefs about the appropriate means of preventing and treating HIV infection and AIDS. Furthermore, ethical challenges were faced regarding site selection since there was a scientific need to conduct the research in settings where HIV incidence was high, but alternatives to study participation should be available. As in most HIV-prevention research, ethical questions surrounded the determination of the appropriate prevention package for all of those enrolled. During the course of the trial, guidance documents and policies emerged that were of direct relevance to the research questions, calling for a balancing of concerns for the research subjects and trial integrity. When the study results were made public, there was a need to ensure access to the treatment shown to be effective that in some cases differed from the guidelines used at the sites where the research was being conducted. In addition, questions were raised about whether there was an obligation to notify subjects about 'unlinked' transmissions of HIV, that is, infections acquired from someone other than the designated sexual partner enrolled in the study.The ethical issues described are limited to those discerned by the authors and not those of other stakeholders who may have identified additional issues or had a different perspective in analyzing them.Understanding the ethical challenges faced in HPTN 052 promises to inform the design and conduct of future complex, long-term clinical trials aimed at addressing critical scientific and public health questions, where data and practice patterns emerge over the course of the trial.

Dataset Information

Undisclosed antiretroviral drug use in a multinational clinical trial (HIV Prevention Trials Network 052).

Publications

Undisclosed antiretroviral drug use in a multinational clinical trial (HIV Prevention Trials Network 052).

Similar Datasets

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