4 results on '"Sheikh, Virginia"'
Search Results
2. Convalescent Plasma for the Treatment of COVID-19: Perspectives of the National Institutes of Health COVID-19 Treatment Guidelines Panel.
- Author
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Pau, Alice K, Pau, Alice K, Aberg, Judith, Baker, Jason, Belperio, Pamela S, Coopersmith, Craig, Crew, Page, Grund, Birgit, Gulick, Roy M, Harrison, Carly, Kim, Arthur, Lane, H Clifford, Masur, Henry, Sheikh, Virginia, Singh, Kanal, Yazdany, Jinoos, Tebas, Pablo, National Institutes of Health COVID-19 Treatment Guidelines Panel, Pau, Alice K, Pau, Alice K, Aberg, Judith, Baker, Jason, Belperio, Pamela S, Coopersmith, Craig, Crew, Page, Grund, Birgit, Gulick, Roy M, Harrison, Carly, Kim, Arthur, Lane, H Clifford, Masur, Henry, Sheikh, Virginia, Singh, Kanal, Yazdany, Jinoos, Tebas, Pablo, and National Institutes of Health COVID-19 Treatment Guidelines Panel
- Abstract
In the United States, the efficacy and safety of convalescent plasma for treating coronavirus disease 2019 (COVID-19) is currently being tested in randomized placebo-controlled clinical trials. Treatment of individual patients with COVID-19 with convalescent plasma outside such trials is also now permitted through U.S. Food and Drug Administration Emergency Use Authorization. Here, members of the National Institutes of Health COVID-19 Treatment Guidelines Panel provide their views regarding use of convalescent plasma for treating COVID-19.
- Published
- 2021
3. Developing Treatment Guidelines During a Pandemic Health Crisis: Lessons Learned From COVID-19.
- Author
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Kuriakose, Safia, Kuriakose, Safia, Singh, Kanal, Pau, Alice K, Daar, Eric, Gandhi, Rajesh, Tebas, Pablo, Evans, Laura, Gulick, Roy M, Lane, H Clifford, Masur, Henry, NIH COVID-19 Treatment Guidelines Panel, Aberg, Judith A, Adimora, Adaora A, Baker, Jason, Kreuziger, Lisa Baumann, Bedimo, Roger, Belperio, Pamela S, Cantrill, Stephen V, Coopersmith, Craig M, Davis, Susan L, Dzierba, Amy L, Gallagher, John J, Glidden, David V, Grund, Birgit, Hardy, Erica J, Hinkson, Carl, Hughes, Brenna L, Johnson, Steven, Keller, Marla J, Kim, Arthur Y, Lennox, Jeffrey L, Levy, Mitchell M, Li, Jonathan Z, Martin, Greg S, Naggie, Susanna, Pavia, Andrew T, Seam, Nitin, Simpson, Steven Q, Swindells, Susan, Tien, Phyllis, Waghmare, Alpana A, Wilson, Kevin C, Yazdany, Jinoos, Zachariah, Philip, Campbell, Danielle M, Harrison, Carly, Burgess, Timothy, Francis, Joseph, Sheikh, Virginia, Uyeki, Timothy M, Walker, Robert, Brooks, John T, Ortiz, Laura Bosque, Davey, Richard T, Doepel, Laurie K, Eisinger, Robert W, Han, Alison, Higgs, Elizabeth S, Nason, Martha C, Crew, Page, Lerner, Andrea M, Lund, Claire, Worthington, Christopher, Kuriakose, Safia, Kuriakose, Safia, Singh, Kanal, Pau, Alice K, Daar, Eric, Gandhi, Rajesh, Tebas, Pablo, Evans, Laura, Gulick, Roy M, Lane, H Clifford, Masur, Henry, NIH COVID-19 Treatment Guidelines Panel, Aberg, Judith A, Adimora, Adaora A, Baker, Jason, Kreuziger, Lisa Baumann, Bedimo, Roger, Belperio, Pamela S, Cantrill, Stephen V, Coopersmith, Craig M, Davis, Susan L, Dzierba, Amy L, Gallagher, John J, Glidden, David V, Grund, Birgit, Hardy, Erica J, Hinkson, Carl, Hughes, Brenna L, Johnson, Steven, Keller, Marla J, Kim, Arthur Y, Lennox, Jeffrey L, Levy, Mitchell M, Li, Jonathan Z, Martin, Greg S, Naggie, Susanna, Pavia, Andrew T, Seam, Nitin, Simpson, Steven Q, Swindells, Susan, Tien, Phyllis, Waghmare, Alpana A, Wilson, Kevin C, Yazdany, Jinoos, Zachariah, Philip, Campbell, Danielle M, Harrison, Carly, Burgess, Timothy, Francis, Joseph, Sheikh, Virginia, Uyeki, Timothy M, Walker, Robert, Brooks, John T, Ortiz, Laura Bosque, Davey, Richard T, Doepel, Laurie K, Eisinger, Robert W, Han, Alison, Higgs, Elizabeth S, Nason, Martha C, Crew, Page, Lerner, Andrea M, Lund, Claire, and Worthington, Christopher
- Abstract
The development of the National Institutes of Health (NIH) COVID-19 Treatment Guidelines began in March 2020 in response to a request from the White House Coronavirus Task Force. Within 4 days of the request, the NIH COVID-19 Treatment Guidelines Panel was established and the first meeting took place (virtually-as did subsequent meetings). The Panel comprises 57 individuals representing 6 governmental agencies, 11 professional societies, and 33 medical centers, plus 2 community members, who have worked together to create and frequently update the guidelines on the basis of evidence from the most recent clinical studies available. The initial version of the guidelines was completed within 2 weeks and posted online on 21 April 2020. Initially, sparse evidence was available to guide COVID-19 treatment recommendations. However, treatment data rapidly accrued based on results from clinical studies that used various study designs and evaluated different therapeutic agents and approaches. Data have continued to evolve at a rapid pace, leading to 24 revisions and updates of the guidelines in the first year. This process has provided important lessons for responding to an unprecedented public health emergency: Providers and stakeholders are eager to access credible, current treatment guidelines; governmental agencies, professional societies, and health care leaders can work together effectively and expeditiously; panelists from various disciplines, including biostatistics, are important for quickly developing well-informed recommendations; well-powered randomized clinical trials continue to provide the most compelling evidence to guide treatment recommendations; treatment recommendations need to be developed in a confidential setting free from external pressures; development of a user-friendly, web-based format for communicating with health care providers requires substantial administrative support; and frequent updates are necessary as clinical evidence rapidly emerges.
- Published
- 2021
4. Recommendations for analytical antiretroviral treatment interruptions in HIV research trials-report of a consensus meeting.
- Author
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Julg, Boris, Julg, Boris, Dee, Lynda, Ananworanich, Jintanat, Barouch, Dan H, Bar, Katharine, Caskey, Marina, Colby, Donn J, Dawson, Liza, Dong, Krista L, Dubé, Karine, Eron, Joseph, Frater, John, Gandhi, Rajesh T, Geleziunas, Romas, Goulder, Philip, Hanna, George J, Jefferys, Richard, Johnston, Rowena, Kuritzkes, Daniel, Li, Jonathan Z, Likhitwonnawut, Udom, van Lunzen, Jan, Martinez-Picado, Javier, Miller, Veronica, Montaner, Luis J, Nixon, Douglas F, Palm, David, Pantaleo, Giuseppe, Peay, Holly, Persaud, Deborah, Salzwedel, Jessica, Salzwedel, Karl, Schacker, Timothy, Sheikh, Virginia, Søgaard, Ole S, Spudich, Serena, Stephenson, Kathryn, Sugarman, Jeremy, Taylor, Jeff, Tebas, Pablo, Tiemessen, Caroline T, Tressler, Randall, Weiss, Carol D, Zheng, Lu, Robb, Merlin L, Michael, Nelson L, Mellors, John W, Deeks, Steven G, Walker, Bruce D, Julg, Boris, Julg, Boris, Dee, Lynda, Ananworanich, Jintanat, Barouch, Dan H, Bar, Katharine, Caskey, Marina, Colby, Donn J, Dawson, Liza, Dong, Krista L, Dubé, Karine, Eron, Joseph, Frater, John, Gandhi, Rajesh T, Geleziunas, Romas, Goulder, Philip, Hanna, George J, Jefferys, Richard, Johnston, Rowena, Kuritzkes, Daniel, Li, Jonathan Z, Likhitwonnawut, Udom, van Lunzen, Jan, Martinez-Picado, Javier, Miller, Veronica, Montaner, Luis J, Nixon, Douglas F, Palm, David, Pantaleo, Giuseppe, Peay, Holly, Persaud, Deborah, Salzwedel, Jessica, Salzwedel, Karl, Schacker, Timothy, Sheikh, Virginia, Søgaard, Ole S, Spudich, Serena, Stephenson, Kathryn, Sugarman, Jeremy, Taylor, Jeff, Tebas, Pablo, Tiemessen, Caroline T, Tressler, Randall, Weiss, Carol D, Zheng, Lu, Robb, Merlin L, Michael, Nelson L, Mellors, John W, Deeks, Steven G, and Walker, Bruce D
- Abstract
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.
- Published
- 2019
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