Recommendations for analytical antiretroviral treatment interruptions in HIV research trials: report of a consensus meeting

Analytical antiretroviral treatment interruption (ATI) is an important feature of HIV research, seeking to achieve sustained viral suppression in the absence of antiretroviral therapy (ART) when the goal is to measure effects of novel therapeutic interventions on time to viral load rebound or altered viral setpoint. Trials with ATIs also intend to determine host, virological, and immunological markers that are predictive of sustained viral control off ART. Although ATI is increasingly incorporated into proof-of-concept trials, no consensus has been reached on strategies to maximise its utility and minimise its risks. In addition, differences in ATI trial designs hinder the ability to compare efficacy and safety of interventions across trials. Therefore, we held a meeting of stakeholders from many interest groups, including scientists, clinicians, ethicists, social scientists, regulators, people living with HIV, and advocacy groups, to discuss the main challenges concerning ATI studies and to formulate recommendations with an emphasis on strategies for risk mitigation and monitoring, ART resumption criteria, and ethical considerations. In this Review, we present the major points of discussion and consensus views achieved with the goal of informing the conduct of ATIs to maximise the knowledge gained and minimise the risk to participants in clinical HIV research

Energy value and bioactive proteins of inulin-enriched tofuproduced by hydrothermal process with chymosin-pepsin rennet

Nutritional properties of inulin-enriched tofu obtained after hydrothermal cooking of soymilk, using chymosin-pepsin rennet and inulin as a functional ingredient, were assessed. This procedure significantly differs from the traditional one. The residual activity (rTIA) of trypsin inhibitors (TIs) and lectins, content of proteins, carbohydrates, fats and their energy values (EV) were suitable for human nutrition. Inulin-enriched tofu was characterised with low rTIA (3.08–5.71%) and TIs content of 3.62–18.99%. Content of Kunitz and Bowman-Birk TIs as well as total TIs content (r = 0.98) in tofu were strongly correlated with tofu protein content. Content of Bowman-Birk polymeric forms (3.11–5.36%) was higher than Bowman-Birk monomeric forms (0.51–2.31%) in inulin-enriched tofu. Low urease activity (0.60–1.78%) indicated that soybean was heated adequately to inactivate TIs. Increasing content of inulin did not increase tofu EV (~18 kJ per g tofu). The proximate composition of inulin-enriched tofu, advantageous rTIA and a very low EV qualifies this product for human nutrition

Recommendations for analytical antiretroviral treatment interruptions in HIV research trials-report of a consensus meeting.

Analytical antiretroviral treatment interruption (ATI) is an important feature of HIV research, seeking to achieve sustained viral suppression in the absence of antiretroviral therapy (ART) when the goal is to measure effects of novel therapeutic interventions on time to viral load rebound or altered viral setpoint. Trials with ATIs also intend to determine host, virological, and immunological markers that are predictive of sustained viral control off ART. Although ATI is increasingly incorporated into proof-of-concept trials, no consensus has been reached on strategies to maximise its utility and minimise its risks. In addition, differences in ATI trial designs hinder the ability to compare efficacy and safety of interventions across trials. Therefore, we held a meeting of stakeholders from many interest groups, including scientists, clinicians, ethicists, social scientists, regulators, people living with HIV, and advocacy groups, to discuss the main challenges concerning ATI studies and to formulate recommendations with an emphasis on strategies for risk mitigation and monitoring, ART resumption criteria, and ethical considerations. In this Review, we present the major points of discussion and consensus views achieved with the goal of informing the conduct of ATIs to maximise the knowledge gained and minimise the risk to participants in clinical HIV research