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1. Long-term open-label vebicorvir for chronic HBV infection: Safety and off-treatment responses

Author

Yuen, Man-Fung, Fung, Scott, Ma, Xiaoli, Nguyen, Tuan T., Hassanein, Tarek, Hann, Hie-Won, Elkhashab, Magdy, Nahass, Ronald G., Park, James S., Jacobson, Ira M., Ayoub, Walid S., Han, Steven-Huy, Gane, Edward J., Zomorodi, Katie, Yan, Ran, Ma, Julie, Knox, Steven J., Stamm, Luisa M., Bonacini, Maurizio, Weilert, Frank, Ramji, Alnoor, Bennett, Michael, Ravendhran, Natarajan, Chan, Sing, Dieterich, Douglas T., Kwo, Paul Yien, Schiff, Eugene R., Bae, Ho S., Lalezari, Jacob, Agarwal, Kosh, and Sulkowski, Mark S.

Published
2024
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2. Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials

Author

Martins, Marcelo D, Cahn, Pedro E, Lopardo, Gustavo D, Porteiro, Norma, Bloch, Mark Theo, Baker, David Alfred, Roth, Norman, Moore, Richard J, Finlayson, Robert James, McMahon, James, Rieger, Armin, Zoufaly, Alexander, Schmied, Brigitte, Hartl, Sylvia, Zangerle, Robert, Smaill, Fiona, Walmsley, Sharon L, Conway, Brian, Rachlis, Anita, Smith, Graham H R, Perez Cortes, Carlos, Afani, Alejandro, Campos Barker, Maria Isabel E, Chahin Anania, Carolina Eugenia, Reyes, Marcelo J. Wolff, Gerstoft, Jan, Weis, Nina, Laursen, Alex Lund, Molina, Jean-Michel, Yazdanpanah, Yazdan, Cotte, Laurent, Raffi, Francois, Slama, Laurence, Morlat, Philippe, Girard, Pierre-Marie, Katlama, Christine, Rockstroh, Juergen K, Arasteh, Keikawus, Esser, Stefan, Stoehr, Albrecht, Stellbrink, Hans-Juergen, Stoll, Matthias, Schuermann, Dirk, Faetkenheuer, Gerd, Bogner, Johannes Richard, Lutz, Thomas, Baumgarten, Axel, Jaeger, Hans, Wiese, Carmen, Gori, Andrea, Migliorino, Guglielmo Marco, Coltan, Gabriel, Constandis, Felicia, Erscoiu, Simona M, Prisacariu, Liviu-Jany, Rugina, Sorin, Streinu-Cercel, Adrian, Pokrovsky, Vadim V, Zakharova, Natalia, Shuldyakov, Andrey Anatolyevich, Ryamova, Elena Pavlovna, Kulagin, Valeriy Viktorovich, Tsybakova, Olga Aleksandrovna, Orlova-Morozova, Elena, Nagimova, Firaya, Voronin, Evgeniy, Shimonova, Tatiana Evgenyevna, Kozyrev, Oleg Anatolyevich, Orrell, Catherine, Lombaard, Johannes Jurgens, Botes, Margaretha Elizabeth, de Jager, Marleen, Segorb, Joaquin Portilla, Gatell Artigas, Josep Maria, Mallolas Masferrer, Josep, Guillen, Santiago Moreno, Perez Elias, Maria Jesus, Arribas Lopez, Jose R, Puigmal, Eugenia Negredo, Podzamczer Palter, Daniel, Ortega, Frederico Pulido, Garcia, Jesus Troya, de los Santos Gil, Ignacio, Berenguer, Juan, Nelson, Mark Richard, Williams, Ian G, Johnson, Margaret A, Khoo, Saye, Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Lwanga, Julianne, Taylor, Steven John, Dockrell, David Harold, Kegg, Stephen, Hagins, Debbie P, Osiyemi, Olayemi O, Prelutsky, David James, Ramgopal, Moti N, Scarsella, Anthony J, Dretler, Robin, DeJesus, Edwin, Bettacchi, Christopher J, Sims III, James, Clay, Patrick G, Bellos, Nicholaos C, Thompson, Melanie A, Montero, Jose, McDonald, Cheryl K, Creticos, Catherine, Shamblaw, David, Terrelonge, Antonio E, Valdes, Martin, Tashima, Karen T, Robbins, William J, Elion, Richard A, Goldstein, Deborah, Slim, Jihad, Lalezari, Jacob Paul, Pushkin, Richard, Lalla-Reddy, Sujata N, Win, Sanda S, Ruane, Peter Jerome, Mills, Anthony Martin, Cade, Jerry L, Campo, Rafael, Dietz, Craig A, Hoffman-Terry, Margaret, Blick, Gary, Rubin, David Scott, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P, Daar, Eric, Kumar, Princy N, Swindells, Susan, Castro, Jose Guillermo, Morales-Ramirez, Javier O, Santiago, Lizette, Santana-Bagur, Jorge L, Vandekerckhove, Linos, Florence, Eric, De Wit, Stephane, Derdelinckx, Inge, Vandercam, Bernard, Belkhir, Leila, De Wet, Joseph, Lebouche, Bertrand, Trottier, Benoit, Longpre, Daniele, Szabo, Jason, LeBlanc, Roger P, Jensen, Werner, Gonzalez, Alvaro Rojas, Beltran, Carlos, Sussmann, Otto Alberto, Velez, Juan Diego, Onate, Jose Millan, Nielsen, Henrik, Degen, Olaf, Stephan, Christoph, Arathoon, Eduardo, Lopez, Rudy Manuel, Rojas Alvarado, Evelyn Michelle, Gonzalez Patzan, Luis Demetrio, Meija, Carlos R, Pinzon, Rodolfo, Parchment, Charles, Sthoeger, Zev, Chowers, Michal, Riesenberg, Klaris, Shahar, Eduardo, Levy, Itzchak, Quintero Perez, Nora Patricia, Andrade-Villanueva, Jaime Federico, Crabtree Ramirez, Brenda Eloisa, Rijnders, Bart, den Hollander, Jan G, Handy, Rupert, Morales, Nilo Bonifacio, Hidalgo, Jose Alfredo, Infante, Rosa Mercedes, Matos Prado, Eduardo Demetrio, Campos, Pablo E, Ticona Chaves, Eduardo Romulo, Pinedo, Yvett, Pacheco, Patricia, Maltez, Fernando Manuel, Cunha, Jose, Neves, Isabel, Serrao, Rosario, Melendez-Rivera, Ivan, Mendoza-Rodriguez, Rafael O, Maldonado-Rivera, Sandra, Ortiz-Lasanta, Grisell, Kizhlo, Svetlana, Freud, Hernando Knobel, Moreno, Jose Sanz, Mendez, Francisco Vera, Mohapi, Lerato, Mitha, Essack Aziz, Mahomed, Akbar Anvar, Fouche, Leon Frederik, Kaplan, Richard, Siddique, Naeem, Hoosen, Farzana, Rassool, Mohammed Siddique, Baraldi, Ezio, Calmy, Alexandra, Cavassini, Matthias, Fehr, Jan, Tsai, Hung-Chin, Lin, Hsi-Hsun, Huang, Chun-Kai, Ko, Wen-Chien, Lin, Yu-Hui, Chen, Su-Jung, Hung, Chien-Ching, Avihingsanon, Anchalee, Kiertiburanakul, Sasisopin, Ratanasuwan, Winai, Supparatpinyo, Khuanchai, Chetchotisakd, Ploenchan, Changpradub, Dhitiwat, Orkin, Chloe, Fox, Ashini, Winston, Alan, Ustianowski, Andrew, Yangco, Bienvenido G, Asmuth, David Michael, Vigil, Karen J, Berger, Daniel S, Bhatti, Laveeza, Campbell, Thomas, Casey, Kathleen K, Liu, Edward, Crofoot, Gordon E, Cunningham, Douglas, Feinberg, Judith, Fichtenbaum, Carl, Balamban Felizarta, Franco Antonio, Jefferson, Thomas T, Johnson, Marc Alexander, Lewis, Stanley T, Luque, Amneris E, Novak, Richard M, Sloan, Louis, Sweet, Donna E, Towner, William J, Zane, Ryan, Riedel, David J, Loftus, Richard Anton, Shon, Alyssa So Young, Mogyoros, Miguel, Tebas, Pablo, Scott, Mia Louise, Parenti, David M, Inciarte Portillo, Alexy, Cahn, Pedro, Lombaard, Johannes, Kumar, Sushma, Campbell, Havilland, Wan, Hong, Teal, Valerie, Jin Xu, Zhi, Asante-Appiah, Ernest, Sklar, Peter, Teppler, Hedy, and Lahoulou, Rima

Published
2024
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4. Safety and efficacy of vebicorvir administered with entecavir in treatment-naïve patients with chronic hepatitis B virus infection

Author

Sulkowski, Mark S., Agarwal, Kosh, Ma, Xiaoli, Nguyen, Tuan T., Schiff, Eugene R., Hann, Hie-Won L., Dieterich, Douglas T., Nahass, Ronald G., Park, James S., Chan, Sing, Han, Steven-Huy B., Gane, Edward J., Bennett, Michael, Alves, Katia, Evanchik, Marc, Yan, Ran, Huang, Qi, Lopatin, Uri, Colonno, Richard, Ma, Julie, Knox, Steven J., Stamm, Luisa M., Bonacini, Maurizio, Jacobson, Ira M., Ayoub, Walid S., Weilert, Frank, Ravendhran, Natarajan, Ramji, Alnoor, Kwo, Paul Yien, Elkhashab, Magdy, Hassanein, Tarek, Bae, Ho S., Lalezari, Jacob P., Fung, Scott K., and Yuen, Man-Fung

Published
2022
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5. Safety and efficacy of vebicorvir in virologically suppressed patients with chronic hepatitis B virus infection

Author

Yuen, Man-Fung, Agarwal, Kosh, Ma, Xiaoli, Nguyen, Tuan T., Schiff, Eugene R., Hann, Hie-Won L., Dieterich, Douglas T., Nahass, Ronald G., Park, James S., Chan, Sing, Han, Steven-Huy B., Gane, Edward J., Bennett, Michael, Alves, Katia, Evanchik, Marc, Yan, Ran, Huang, Qi, Lopatin, Uri, Colonno, Richard, Ma, Julie, Knox, Steven J., Stamm, Luisa M., Bonacini, Maurizio, Jacobson, Ira M., Ayoub, Walid S., Weilert, Frank, Ravendhran, Natarajan, Ramji, Alnoor, Kwo, Paul Yien, Elkhashab, Magdy, Hassanein, Tarek, Bae, Ho S., Lalezari, Jacob P., Fung, Scott K., and Sulkowski, Mark S.

Published
2022
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7. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study

Author

Lataillade, Max, Lalezari, Jacob P, Kozal, Michael, Aberg, Judith A, Pialoux, Gilles, Cahn, Pedro, Thompson, Melanie, Molina, Jean-Michel, Moreno, Santiago, Grinsztejn, Beatriz, Diaz, Ricardo S, Castagna, Antonella, Kumar, Princy N, Latiff, Gulam H, De Jesus, Edwin, Wang, Marcia, Chabria, Shiven, Gartland, Margaret, Pierce, Amy, Ackerman, Peter, and Llamoso, Cyril

Published
2020
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8. 365. Durable efficacy and robust CD4+ T-cell count improvement observed across age, race, sex, and geographic subgroups of heavily treatment-experienced people with multidrug-resistant HIV-1 after 240 weeks of fostemsavir treatment

Author

Dyson, Alftan, primary, Aberg, Judith A, additional, Molina, Jean-Michel, additional, Cassetti, Isabel, additional, Kozal, Michael, additional, Treviño-Pérez, Sandra, additional, Latiff, Gulam, additional, Lalezari, Jacob, additional, Pialoux, Gilles, additional, Li, Bo, additional, Prakash, Manyu, additional, Clark, Andrew, additional, Tenorio, Allan R, additional, Pierce, Amy, additional, and Lataillade, Max, additional

Published
2023
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10. Sofosbuvir and Ribavirin for Hepatitis C in Patients With HIV Coinfection

Author

Sulkowski, Mark S, Naggie, Susanna, Lalezari, Jacob, Fessel, Walford Jeffrey, Mounzer, Karam, Shuhart, Margaret, Luetkemeyer, Anne F, Asmuth, David, Gaggar, Anuj, Ni, Liyun, Svarovskaia, Evguenia, Brainard, Diana M, Symonds, William T, Subramanian, G Mani, McHutchison, John G, Rodriguez-Torres, Maribel, and Dieterich, Douglas

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Immunology, Emerging Infectious Diseases, Liver Disease, Clinical Research, Digestive Diseases, Hepatitis - C, Genetics, Clinical Trials and Supportive Activities, HIV/AIDS, Infectious Diseases, Hepatitis, Chronic Liver Disease and Cirrhosis, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Administration, Oral, Adult, Aged, Antiviral Agents, Coinfection, Drug Administration Schedule, Drug Therapy, Combination, Female, Genotype, HIV Infections, Hepacivirus, Hepatitis C, Humans, Male, Middle Aged, RNA, Viral, Ribavirin, Sofosbuvir, Treatment Outcome, Uridine Monophosphate, Viral Load, Young Adult, PHOTON-1 Investigators, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

ImportanceTreatment of hepatitis C virus (HCV) infection in patients also infected with human immunodeficiency virus (HIV) has been limited due to drug interactions with antiretroviral therapies (ARTs) and the need to use interferon.ObjectiveTo determine the rates of HCV eradication (sustained virologic response [SVR]) and adverse events in patients with HCV-HIV coinfection receiving sofosbuvir and ribavirin treatment.Design, setting, and participantsOpen-label, nonrandomized, uncontrolled phase 3 trial conducted at 34 treatment centers in the United States and Puerto Rico (August 2012-November 2013) evaluating treatment with sofosbuvir and ribavirin among patients with HCV genotypes 1, 2, or 3 and concurrent HIV. Patients were required to be receiving ART with HIV RNA values of 50 copies/mL or less and a CD4 T-cell count of more than 200 cells/μL or to have untreated HIV infection with a CD4 T-cell count of more than 500 cells/μL. Of the treatment-naive patients, 114 had HCV genotype 1 and 68 had HCV genotype 2 or 3, and 41 treatment experienced participants who had been treated with peginterferon-ribavirin had HCV genotype 2 or 3, for a total of 223 participants.InterventionsTreatment-naive patients with HCV genotype 2 or 3 received 400 mg of sofosbuvir and weight-based ribavirin for 12 weeks and treatment-naive patients with HCV genotype 1 and treatment-experienced patients with HCV genotype 2 or 3 received the same treatment for 24 weeks.Main outcomes and measuresThe primary study outcome was the proportion of patients with SVR (serum HCV

Published
2014

11. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 48-week results of a randomised, double-blind, phase 3, non-inferiority trial

Author

Martins, Marcelo, Cahn, Pedro Enrique, Lopardo, Gustavo D., Porteiro, Norma, Bloch, Mark Theo, Baker, David Alfred, Roth, Norman, Moore, Richard James, Finlayson, Robert James, McMahon, James, Rieger, Armin, Zoufaly, Alexander, Hartl, Sylvia, Zangerle, Robert, Smaill, Fiona, Walmsley, Sharon L., Conway, Brian, Rachlis, Anita, Smith, Graham H.R., Perez, Carlos, Afani, Alejandro, Campos Barker, Maria Isabel E., Chahin, Carolina Eugenia, Wolff Reyes, Marcelo, Gerstoft, Jan, Weis, Nina, Laursen, Alex Lund, Molina, Jean-Michel, Yazdanpanah, Yazdan, Cotte, Laurent, Raffi, Francois, Morlat, Philippe, Girard, Pierre-Marie, Katlama, Christine, Rockstroh, Juergen K., Arasteh, Keikawus, Esser, Stefan, Stoehr, Albrecht, Stellbrink, Hans-Juergen, Stoll, Matthias, Schuermann, Dirk, Faetkenheuer, Gerd, Bogner, Johannes, Lutz, Thomas, Baumgarten, Axel, Jaeger, Hans, Gori, Andrea, Coltan, Gabriel, Constandis, Felicia, Erscoiu, Simona Manuela, Prisacariu, Liviu-Jany, Rugina, Sorin, Streinu-Cercel, Adrian, Pokrovsky, Vadim Valentinovich, Zakharova, Natalia V., Shuldyakov, Andrey Anatolyevich, Ryamova, Elena Pavlovna, Kulagin, Valeriy Viktorovich, Tsybakova, Olga Aleksandrovna, Orlova-Morozova, Elena, Nagimova, Firaya, Voronin, Evgeniy, Shimonova, Tatyana Evgenyevna, Kozyrev, Oleg Anatolyevich, Orrell, Catherine, Lombaard, Johannes Jurgens, Botes, Margaretha Elizabeth, Portilla, Joaquin, Gatell, Josep Maria, Perez, Maria Jesus, Arribas, Jose Ramon, Negredo, Eugenia, Podzamczer, Daniel, Pulido, Federico, Troya, Jesus, De los Santos, Ignacio, Berenguer, Juan, Williams, Ian G., Johnson, Margaret A., Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Taylor, Steven John, Kegg, Stephen, Hagins, Debbie P., Osiyemi, Olayemi O., Prelutsky, David James, Ramgopal, Moti N., Dretler, Robin, DeJesus, Edwin, Sloan, Louis, Lewis, Stanley T., Clay, Patrick G., Bellos, Nicholaos C., Thompson, Melanie A., Montero, Jose, McDonald, Cheryl K., Creticos, Catherine, Shamblaw, David, Terrelonge, Antonio E., Valdes, Martin, Tashima, Karen T., Robbins, William J., Felizarta, Franco Antonio, Elion, Richard A., Slim, Jihad, Lalezari, Jacob Paul, Lalla-Reddy, Sujata N., Ruane, Peter Jerome, Mills, Anthony, Cade, Jerry L., Campo, Rafael E., Dietz, Craig A., Blick, Gary, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P., Daar, Eric, Kumar, Princy N., Swindells, Susan, Castro, Jose Guillermo, Morales-Ramirez, Javier O., Santiago, Lizette, Santana-Bagur, Jorge L., Squires, Kathleen, Sax, Paul E, Cahn, Pedro, Lombaard, Johan, Lai, Ming-Tain, Xu, Xia, Rodgers, Anthony, Lupinacci, Lisa, Kumar, Sushma, Sklar, Peter, Nguyen, Bach-Yen, Hanna, George J, and Hwang, Carey

Published
2018
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13. Phase 2 gene therapy trial of an anti-HIV ribozyme in autologous CD34+ cells

Author

Mitsuyasu, Ronald T, Merigan, Thomas C, Carr, Andrew, Zack, Jerome A, Winters, Mark A, Workman, Cassy, Bloch, Mark, Lalezari, Jacob, Becker, Stephen, Thornton, Lorna, Akil, Bisher, Khanlou, Homayoon, Finlayson, Robert, McFarlane, Robert, Smith, Don E, Garsia, Roger, Ma, David, Law, Matthew, Murray, John M, von Kalle, Christof, Ely, Julie A, Patino, Sharon M, Knop, Alison E, Wong, Philip, Todd, Alison V, Haughton, Margaret, Fuery, Caroline, Macpherson, Janet L, Symonds, Geoff P, Evans, Louise A, Pond, Susan M, and Cooper, David A

Subjects
Biomedical and Clinical Sciences, Immunology, HIV/AIDS, Clinical Trials and Supportive Activities, Pediatric AIDS, Gene Therapy, Genetics, Clinical Research, Pediatric, Infectious Diseases, 6.2 Cellular and gene therapies, Evaluation of treatments and therapeutic interventions, Development of treatments and therapeutic interventions, 5.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Infection, Adult, Antigens, CD34, Base Sequence, Double-Blind Method, Female, Genetic Therapy, HIV Infections, HIV-1, Humans, Male, Placebos, RNA, Catalytic, Viral Load, Medical and Health Sciences, Biomedical and clinical sciences, Health sciences
Abstract

Gene transfer has potential as a once-only treatment that reduces viral load, preserves the immune system and avoids lifetime highly active antiretroviral therapy. This study, which is to our knowledge the first randomized, double-blind, placebo-controlled, phase 2 cell-delivered gene transfer clinical trial, was conducted in 74 HIV-1-infected adults who received a tat-vpr-specific anti-HIV ribozyme (OZ1) or placebo delivered in autologous CD34+ hematopoietic progenitor cells. There were no OZ1-related adverse events. There was no statistically significant difference in viral load between the OZ1 and placebo group at the primary end point (average at weeks 47 and 48), but time-weighted areas under the curve from weeks 40-48 and 40-100 were significantly lower in the OZ1 group. Throughout the 100 weeks, CD4+ lymphocyte counts were higher in the OZ1 group. This study indicates that cell-delivered gene transfer is safe and biologically active in individuals with HIV and can be developed as a conventional therapeutic product.

Published
2009

14. Safety and efficacy of doravirine as first-line therapy in adults with HIV-1: week 192 results from the open-label extensions of the DRIVE-FORWARD and DRIVE-AHEAD phase 3 trials

Author

Orkin, Chloe, Molina, Jean-Michel, Cahn, Pedro, Lombaard, Johannes, Supparatpinyo, Khuanchai, Kumar, Sushma, Campbell, Havilland, Wan, Hong, Teal, Valerie, Jin Xu, Zhi, Asante-Appiah, Ernest, Sklar, Peter, Teppler, Hedy, Lahoulou, Rima, Martins, Marcelo D, Cahn, Pedro E, Lopardo, Gustavo D, Porteiro, Norma, Bloch, Mark Theo, Baker, David Alfred, Roth, Norman, Moore, Richard J, Finlayson, Robert James, McMahon, James, Rieger, Armin, Zoufaly, Alexander, Schmied, Brigitte, Hartl, Sylvia, Zangerle, Robert, Smaill, Fiona, Walmsley, Sharon L, Conway, Brian, Rachlis, Anita, Smith, Graham H R, Perez Cortes, Carlos, Afani, Alejandro, Campos Barker, Maria Isabel E, Chahin Anania, Carolina Eugenia, Reyes, Marcelo J. Wolff, Gerstoft, Jan, Weis, Nina, Laursen, Alex Lund, Molina, Jean-Michel, Yazdanpanah, Yazdan, Cotte, Laurent, Raffi, Francois, Slama, Laurence, Morlat, Philippe, Girard, Pierre-Marie, Katlama, Christine, Rockstroh, Juergen K, Arasteh, Keikawus, Esser, Stefan, Stoehr, Albrecht, Stellbrink, Hans-Juergen, Stoll, Matthias, Schuermann, Dirk, Faetkenheuer, Gerd, Bogner, Johannes Richard, Lutz, Thomas, Baumgarten, Axel, Jaeger, Hans, Wiese, Carmen, Gori, Andrea, Migliorino, Guglielmo Marco, Coltan, Gabriel, Constandis, Felicia, Erscoiu, Simona M, Prisacariu, Liviu-Jany, Rugina, Sorin, Streinu-Cercel, Adrian, Pokrovsky, Vadim V, Zakharova, Natalia, Shuldyakov, Andrey Anatolyevich, Ryamova, Elena Pavlovna, Kulagin, Valeriy Viktorovich, Tsybakova, Olga Aleksandrovna, Orlova-Morozova, Elena, Nagimova, Firaya, Voronin, Evgeniy, Shimonova, Tatiana Evgenyevna, Kozyrev, Oleg Anatolyevich, Orrell, Catherine, Lombaard, Johannes Jurgens, Botes, Margaretha Elizabeth, de Jager, Marleen, Segorb, Joaquin Portilla, Gatell Artigas, Josep Maria, Mallolas Masferrer, Josep, Guillen, Santiago Moreno, Perez Elias, Maria Jesus, Arribas Lopez, Jose R, Puigmal, Eugenia Negredo, Podzamczer Palter, Daniel, Ortega, Frederico Pulido, Garcia, Jesus Troya, de los Santos Gil, Ignacio, Berenguer, Juan, Nelson, Mark Richard, Williams, Ian G, Johnson, Margaret A, Khoo, Saye, Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Lwanga, Julianne, Taylor, Steven John, Dockrell, David Harold, Kegg, Stephen, Hagins, Debbie P, Osiyemi, Olayemi O, Prelutsky, David James, Ramgopal, Moti N, Scarsella, Anthony J, Dretler, Robin, DeJesus, Edwin, Bettacchi, Christopher J, Sims III, James, Clay, Patrick G, Bellos, Nicholaos C, Thompson, Melanie A, Montero, Jose, McDonald, Cheryl K, Creticos, Catherine, Shamblaw, David, Terrelonge, Antonio E, Valdes, Martin, Tashima, Karen T, Robbins, William J, Elion, Richard A, Goldstein, Deborah, Slim, Jihad, Lalezari, Jacob Paul, Pushkin, Richard, Lalla-Reddy, Sujata N, Win, Sanda S, Ruane, Peter Jerome, Mills, Anthony Martin, Cade, Jerry L, Campo, Rafael, Dietz, Craig A, Hoffman-Terry, Margaret, Blick, Gary, Rubin, David Scott, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P, Daar, Eric, Kumar, Princy N, Swindells, Susan, Castro, Jose Guillermo, Morales-Ramirez, Javier O, Santiago, Lizette, Santana-Bagur, Jorge L, Vandekerckhove, Linos, Florence, Eric, De Wit, Stephane, Derdelinckx, Inge, Vandercam, Bernard, Belkhir, Leila, De Wet, Joseph, Lebouche, Bertrand, Trottier, Benoit, Longpre, Daniele, Szabo, Jason, LeBlanc, Roger P, Jensen, Werner, Gonzalez, Alvaro Rojas, Beltran, Carlos, Sussmann, Otto Alberto, Velez, Juan Diego, Onate, Jose Millan, Nielsen, Henrik, Degen, Olaf, Stephan, Christoph, Arathoon, Eduardo, Lopez, Rudy Manuel, Rojas Alvarado, Evelyn Michelle, Gonzalez Patzan, Luis Demetrio, Meija, Carlos R, Pinzon, Rodolfo, Parchment, Charles, Sthoeger, Zev, Chowers, Michal, Riesenberg, Klaris, Shahar, Eduardo, Levy, Itzchak, Quintero Perez, Nora Patricia, Andrade-Villanueva, Jaime Federico, Crabtree Ramirez, Brenda Eloisa, Rijnders, Bart, den Hollander, Jan G, Handy, Rupert, Morales, Nilo Bonifacio, Hidalgo, Jose Alfredo, Infante, Rosa Mercedes, Matos Prado, Eduardo Demetrio, Campos, Pablo E, Ticona Chaves, Eduardo Romulo, Pinedo, Yvett, Pacheco, Patricia, Maltez, Fernando Manuel, Cunha, Jose, Neves, Isabel, Serrao, Rosario, Melendez-Rivera, Ivan, Mendoza-Rodriguez, Rafael O, Maldonado-Rivera, Sandra, Ortiz-Lasanta, Grisell, Kizhlo, Svetlana, Freud, Hernando Knobel, Moreno, Jose Sanz, Mendez, Francisco Vera, Mohapi, Lerato, Mitha, Essack Aziz, Mahomed, Akbar Anvar, Fouche, Leon Frederik, Kaplan, Richard, Siddique, Naeem, Hoosen, Farzana, Rassool, Mohammed Siddique, Baraldi, Ezio, Calmy, Alexandra, Cavassini, Matthias, Fehr, Jan, Tsai, Hung-Chin, Lin, Hsi-Hsun, Huang, Chun-Kai, Ko, Wen-Chien, Lin, Yu-Hui, Chen, Su-Jung, Hung, Chien-Ching, Avihingsanon, Anchalee, Kiertiburanakul, Sasisopin, Ratanasuwan, Winai, Supparatpinyo, Khuanchai, Chetchotisakd, Ploenchan, Changpradub, Dhitiwat, Orkin, Chloe, Fox, Ashini, Winston, Alan, Ustianowski, Andrew, Yangco, Bienvenido G, Asmuth, David Michael, Vigil, Karen J, Berger, Daniel S, Bhatti, Laveeza, Campbell, Thomas, Casey, Kathleen K, Liu, Edward, Crofoot, Gordon E, Cunningham, Douglas, Feinberg, Judith, Fichtenbaum, Carl, Balamban Felizarta, Franco Antonio, Jefferson, Thomas T, Johnson, Marc Alexander, Lewis, Stanley T, Luque, Amneris E, Novak, Richard M, Sloan, Louis, Sweet, Donna E, Towner, William J, Zane, Ryan, Riedel, David J, Loftus, Richard Anton, Shon, Alyssa So Young, Mogyoros, Miguel, Tebas, Pablo, Scott, Mia Louise, Parenti, David M, and Inciarte Portillo, Alexy

Abstract

In two phase 3 trials for first-line therapy in adults with HIV-1, doravirine showed non-inferior efficacy, a favourable safety profile, and a superior lipid profile to darunavir and efavirenz through to 48 and 96 weeks. Here we report 192-week results from both studies.

Published
2024
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15. Safety and efficacy of the HIV-1 attachment inhibitor prodrug BMS-663068 in treatment-experienced individuals: 24 week results of AI438011, a phase 2b, randomised controlled trial

Author

Lalezari, Jacob P, Latiff, Gulam H, Brinson, Cynthia, Echevarría, Juan, Treviño-Pérez, Sandra, Bogner, Johannes R, Thompson, Melanie, Fourie, Jan, Sussmann Pena, Otto A, Mendo Urbina, Fernando C, Martins, Marcelo, Diaconescu, Iulian G, Stock, David A, Joshi, Samit R, Hanna, George J, and Lataillade, Max

Published
2015
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17. EDP-514 in healthy subjects and nucleos(t)ide reverse transcriptase inhibitor-suppressed patients with chronic hepatitis B

Author

Feld, Jordan J, primary, Lawitz, Eric, additional, Nguyen, Tuan, additional, Lalezari, Jacob, additional, Hassanein, Tarek, additional, Martin, Paul, additional, Han, Steven-Huy, additional, Dieterich, Douglas, additional, Giard, Jeanne-Marie, additional, De La Rosa, Guy, additional, Ahmad, Alaa, additional, Luo, Ed, additional, Conery, Annie L, additional, and Adda, Nathalie, additional

Published
2022
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20. EDP-514, a novel pangenotypic class II hepatitis B virus core inhibitor: final results of a 28-day phase 1b study in nuc-suppressed chronic hepatitis B patients

Author

Feld, Jordan, primary, Lawitz, Eric, additional, Nguyen, Tuan T, additional, Lalezari, Jacob P, additional, Hassanein, Tarek, additional, Martin, Paul, additional, Han, Steven-Huy B, additional, Dieterich, Douglas T, additional, Giard, Jeanne-Marie, additional, De La Rosa, Guy, additional, Ahmad, Alaa, additional, Luo, Ed, additional, Conery, Annie, additional, and Adda, Nathalie, additional

Published
2022
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21. Deeper virologic suppression with the addition of vebicorvir, a first-generation hepatitis B core inhibitor, to entecavir correlates with reduced inflammation and fibrosis-4 index in treatment naïve patients with HBeAg positive chronic hepatitis B

Author

Sulkowski, Mark S, primary, Fung, Scott K, additional, Ma, Xiaoli, additional, Nguyen, Tuan T, additional, Schiff, Eugene R., additional, Hann, Hie-Won L, additional, Dieterich, Douglas T, additional, Nahass, Ronald G, additional, Park, James S, additional, Chan, Sing, additional, Han, Steven-Huy B, additional, Gane, Edward J, additional, Bennett, Michael, additional, Yan, Ran, additional, Liu, Jieming, additional, Ma, Julie, additional, Knox, Steven J, additional, Stamm, Luisa M, additional, Bonacini, Maurizio, additional, Jacobson, Ira M, additional, Ayoub, Walid S, additional, Weilert, Frank, additional, Ravendhran, Natarajan, additional, Ramji, Alnoor, additional, Kwo, Paul Yien, additional, Elkhashab, Magdy, additional, Hassanein, Tarek, additional, Bae, Ho S, additional, Lalezari, Jacob P, additional, Agarwal, Kosh, additional, and Yuen, Man-Fung, additional

Published
2022
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22. Suppression of human and simian immunodeficiency virus replication with the CCR5-specific antibody Leronlimab in two species

Author

Chang, Xiao L., primary, Reed, Jason S., additional, Webb, Gabriela M., additional, Wu, Helen L., additional, Le, Jimmy, additional, Bateman, Katherine B., additional, Greene, Justin M., additional, Pessoa, Cleiton, additional, Waytashek, Courtney, additional, Weber, Whitney C., additional, Hwang, Joseph, additional, Fischer, Miranda, additional, Moats, Cassandra, additional, Shiel, Oriene, additional, Bochart, Rachele M., additional, Crank, Hugh, additional, Siess, Don, additional, Giobbi, Travis, additional, Torgerson, Jeffrey, additional, Agnor, Rebecca, additional, Gao, Lina, additional, Dhody, Kush, additional, Lalezari, Jacob P., additional, Bandar, Ivo Sah, additional, Carnate, Alnor M., additional, Pang, Alina S., additional, Corley, Michael J., additional, Kelly, Scott, additional, Pourhassan, Nader, additional, Smedley, Jeremy, additional, Bimber, Benjamin N., additional, Hansen, Scott G., additional, Ndhlovu, Lishomwa C., additional, and Sacha, Jonah B., additional

Published
2022
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23. Supplemental Material - EDP-514 in healthy subjects and nucleos(t)ide reverse transcriptase inhibitor-suppressed patients with chronic hepatitis B

Author

Feld, Jordan J, Lawitz, Eric, Nguyen, Tuan, Lalezari, Jacob, Hassanein, Tarek, Martin, Paul, Han, Steven-Huy, Dieterich, Douglas, Giard, Jeanne-Marie, De La Rosa, Guy, Ahmad, Alaa, Luo, Ed, Conery, Annie L, and Adda, Nathalie

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplementary Material for EDP-514 in healthy subjects and nucleos(t)ide reverse transcriptase inhibitor-suppressed patients with chronic hepatitis B by Jordan J Feld, Eric Lawitz, Tuan Nguyen, Jacob Lalezari, Tarek Hassanein, Paul Martin, Steven-Huy Han, Douglas Dieterich, Jeanne-Marie Giard, Guy De La Rosa, Alaa Ahmad, Ed Luo, Annie L Conery, and Nathalie Adda in Antiviral Therapy.

Published
2022
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25. Safety and Immunogenicily of a Replication-Incompetent Adenovirus Type 5 HIV-1 Clade B Gag/pol/nef Vaccine in Healthy Adults

Author

Priddy, Frances H., Brown, Deborah, Kublin, James, Monahan, Kathleen, Wright, David P., Lalezari, Jacob, Santiago, Steven, Marmor, Michael, Lally, Michelle, Novak, Richard M., Brown, Stephen J., Kulkarni, Priya, Dubey, Sheri A., Kierstead, Lisa S., Casimiro, Danilo R., Mogg, Robin, DiNubile, Mark J., Shiver, John W., Leavitt, Randi Y., Robertson, Michael N., Mehrotra, Devan V., and Quirk, Erin

Published
2008
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31. Daclatasvir in Combination With Asunaprevir and Beclabuvir for Hepatitis C Virus Genotype 1 Infection With Compensated Cirrhosis

Author

Muir, Andrew J., Poordad, Fred, Lalezari, Jacob, Everson, Gregory, Dore, Gregory J., Herring, Robert, Sheikh, Aasim, Kwo, Paul, Hézode, Christophe, Pockros, Paul J., Tran, Albert, Yozviak, Joseph, Reau, Nancy, Ramji, Alnoor, Stuart, Katherine, Thompson, Alexander J., Vierling, John, Freilich, Bradley, Cooper, James, Ghesquiere, Wayne, Yang, Rong, McPhee, Fiona, Hughes, Eric A., Swenson, E. Scott, and Yin, Philip D.

Published
2015
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32. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study

Author

Nelson, David R., Cooper, James N., Lalezari, Jacob P., Lawitz, Eric, Pockros, Paul J., Gitlin, Norman, Freilich, Bradley F., Younes, Ziad H., Harlan, William, Ghalib, Reem, Oguchi, Godson, Thuluvath, Paul J., Ortiz-Lasanta, Grisell, Rabinovitz, Mordechai, Bernstein, David, Bennett, Michael, Hawkins, Trevor, Ravendhran, Natarajan, Sheikh, Aasim M., Varunok, Peter, Kowdley, Kris V., Hennicken, Delphine, McPhee, Fiona, Rana, Khurram, and Hughes, Eric A.

Published
2015
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38. ABT-450/r–Ombitasvir and Dasabuvir with or without Ribavirin for HCV

Author

Ferenci, Peter, Bernstein, David, Lalezari, Jacob, Cohen, Daniel, Luo, Yan, Cooper, Curtis, Tam, Edward, Marinho, Rui T., Tsai, Naoky, Nyberg, Anders, Box, Terry D., Younes, Ziad, Enayati, Pedram, Green, Sinikka, Baruch, Yaacov, Bhandari, Bal Raj, Caruntu, Florin Alexandru, Sepe, Thomas, Chulanov, Vladimir, Janczewska, Ewa, Rizzardini, Giuliano, Gervain, Judit, Planas, Ramon, Moreno, Christophe, Hassanein, Tarek, Xie, Wangang, King, Martin, Podsadecki, Thomas, and Reddy, Rajender K.

Published
2014
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39. Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection

Author

Afdhal, Nezam, Reddy, Rajender K., Nelson, David R., Lawitz, Eric, Gordon, Stuart C., Schiff, Eugene, Nahass, Ronald, Ghalib, Reem, Gitlin, Norman, Herring, Robert, Lalezari, Jacob, Younes, Ziad H., Pockros, Paul J., Di Bisceglie, Adrian M., Arora, Sanjeev, Subramanian, Mani G., Zhu, Yanni, Dvory-Sobol, Hadas, Yang, Jenny C., Pang, Phillip S., Symonds, William T., McHutchison, John G., Muir, Andrew J., Sulkowski, Mark, and Kwo, Paul

Published
2014
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40. Infusion of CCR5 Gene-Edited T Cells Allows Immune Reconstitution, HIV Reservoir Decay, and Long-Term Virological Control

Author

Zeidan, Joumana, primary, Sharma, Ashish A., additional, Lee, Gary, additional, Raad, Angie, additional, Fromentin, Remi, additional, Fourati, Slim, additional, Ghneim, Khader, additional, Sanchez, Gabriela P., additional, Benne, Clarisse, additional, Canderan, Glenda, additional, Procopio, Francesco A., additional, Balderas, Robert, additional, Monette, Georges, additional, Lalezari, Jacob P., additional, Heffernan, Jane M., additional, Sabbagh, Laurent, additional, Chomont, Nicolas, additional, Ando, Dale, additional, Deeks, Steven G., additional, and Sekaly, Rafick-Pierre, additional

Published
2021
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41. Maraviroc for previously treated patients with R5 HIV-1 infection

Author

Gulick, Roy M, Lalezari, Jacob, Goodrich, James, Clumeck, Nathan, DeJesus, Edwinm, Horban, Andrzej, Nadler, Jeffrey, Clotet, Bonaventura, Karlsson, Anders, Wohlfeiler, Michael, Montana, John B, McHale, Mary, Sullivan, John, Ridgway, Caroline, Felstead, Steve, Dunne, Michael W., van der Ryst, Elna, and Mayer, Howard

Subjects
HIV infection -- Care and treatment, HIV patients -- Health aspects, Maraviroc -- Usage, Maraviroc -- Health aspects
Abstract

A study was conducted to establish whether the use of Maraviroc was effective in reducing HIV-1 infection and increasing the CD4 count among previously treated patients with R5 HIV-1 infection. Results indicated that Maraviroc was effective in reducing HIV-1 infection and increasing CD4 count in R5 HIV-1 infected patients.

Published
2008

42. TORO: ninety-six-week virologic and immunologic response and safety evaluation of enfuvirtide with an optimized background of antiretrovirals

Author

Reynes, Jacques, Arasteh, Keikawus, Clotet, Bonaventura, Cohen, Calvin, Cooper, David A., Delfraissy, Jean-Francois, Eron, Joseph J., Jr., Henry, Keith, Katlama, Christine, Kuritzkes, Daniel R., Lalezari, Jacob P., Lange, Joep, Lazzarin, Adriano, Montaner, Julio S.G., Nelson, Mark, O'Hearn, Mary, Stellbrink, Hans-Jurgen, Trottier, Benoit, Walmsley, Sharon L., Buss, Neil E., DeMasi, Ralph, Chung, Jain, Donatacci, Lucille, Guimaraes, Denise, Rowell, Lucy, Valentine, Adeline, Wilkinson, Martin, and Salgo, Miklos P.

Subjects
Enfuvirtide -- Health aspects, Enfuvirtide -- Research, Anti-HIV agents -- Health aspects, Anti-HIV agents -- Research, Antiviral agents -- Health aspects, Antiviral agents -- Research, HIV patients -- Care and treatment, HIV patients -- Research, Health
Abstract

The additional 48-week optional treatment extension of the T-20 versus Optimized Regimen Only (TORO) studies evaluated long-term safety and efficacy of enfuvirtide (ENF) through week 96 in patients receiving ENF plus optimized background (OB) and patients switching to ENF plus OB from OB alone. Patient randomization was 2:1 to ENF plus OB (n = 663) and OB (n = 334), of which 89.7% and 89.8% were male, 89.3% and 88.6% were Caucasian, and median age was 41 and 42 years, respectively. HIV risk factors were comparable between the ENF plus OB and OB groups with the major factors being 65.2% versus 66.2% homosexual contact, 17.8% versus 19.8% heterosexual contact, 4.1% versus 4.8% bisexual contact, respectively, and 6.9% injection drug use in both groups. OB patients were allowed to switch to ENF plus OB at virologic failure before week 48 and required to switch at week 48 to continue in the study (n = 230). Efficacy and safety assessments were conducted for each group. At week 96, 55% of ENF plus OB subjects completed the study and 26.5% achieved a viral load of less than 400 copies per milliliter (17.5% achieved less than 50 copies per milliliter). Viral load and CD4 mean change from baseline was -2.1 and -1.1 [log.sub.10] HIV-1-RNA copies per milliliter and +166 and +116 CD4 cells/[mm.sup.3] for ENF plus OB and switch patients, respectively. No new ENF-related safety issues emerged in weeks 48-96. Injection site reactions led to discontinuation in 7% and 10% of ENF plus OB and switch patients, respectively. In conclusion, these data demonstrate durable efficacy and safety of ENF over 96 weeks and that early use of ENF in combination with other agents for the treatment of antiretroviral-experienced HIV-infected subjects is beneficial.

Published
2007

44. Disruption of CCR5 signaling to treat COVID-19-associated cytokine storm: Case series of four critically ill patients treated with leronlimab

Author

Agresti, Nicholas, primary, Lalezari, Jacob P., additional, Amodeo, Phillip P., additional, Mody, Kabir, additional, Mosher, Steven F., additional, Seethamraju, Harish, additional, Kelly, Scott A., additional, Pourhassan, Nader Z., additional, Sudduth, C. David, additional, Bovinet, Christopher, additional, ElSharkawi, Ahmed E., additional, Patterson, Bruce K., additional, Stephen, Reejis, additional, Sacha, Jonah B., additional, Wu, Helen L., additional, Gross, Seth A., additional, and Dhody, Kush, additional

Published
2021
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46. Safety of enfuvirtide in combination with an optimized background of antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks

Author

Troittier, Benoit, Walmsley, Sharon, Reynes, Jacues, Piliero, Peter, O'Hearn, Mary, Nelson, Mark, Montaner, Julio, Lazzarin, Adriano, Lalezari, Jacob, Katlama, Christine, Henry, Keith, Cooper, David, Clotet, Bonaventura, Arasteh, Keikawus, Delfraissy, Jean-Francois, Stellbrink, Hans-Jurgen, Lange, Joep, Kuritzkes, Daniel, Eron, Joseph J., Jr., Cohen, Calvin, Kinchelow, Tosca, Bertasso, Anne, Labriola-Tompkins, Emily, Shikhman, Anna, Atkins, Belinda, Bourdeau, Laurence, Natale, Christopher, Hughes, Fiona, Jain Chung, Guimaraes, Denise, Drobnes, Claude, Bader-Weder, Silvia, DeMasi, Ralph, Smiley, Lynn, and Salgo, Miklos P.

Subjects
Antiviral agents -- Research, HIV infection -- Care and treatment, Drug therapy, Combination, Health
Abstract

The analysis of pooled safety data from the pivotal phase three T-20 Versus Optimized Background Regimen Only (TORO) trials indicates that enfuvirtide is a well-tolerated antiretroviral agent with a maintained safety profile over 48 weeks in treatment-experienced HIV-1-infected adults. It is found that the rates of other adverse agents favored enfuvirtide or were generally comparable between treatments.

Published
2005

47. Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 versus optimized background regimen into 1 and 2 clinical trials

Author

Nelson, Mark, Arasteh, Keikawus, Clotet, Bonaventura, Cooper, David A., Henry, Keith, Katlama, Christine, Lalezari, Jacob P., Lazzarin, Adriano, Montaner, Julio S.G., O'Hearn, Mary, Piliero, Peter J., Reynes, Jacques, Cohen, Calvin, Eron, Joseph J., Jr., Kuritzkes, Daniel R., Lange, Joep, Stellbrink, Hans-Jurgen, Delfraissy, Jean-Francois, Buss, Neil E., Donatacci, Lucille, Wat, Cynthia, Gulmaraes, Denise, Demasi, Ralph, Jain Chung, and Salgo, Miklos P.

Subjects
Antiviral agents -- Research, Antiviral agents -- Licensing, certification and accreditation, HIV infection -- Drug therapy, Health
Abstract

Exploratory analyses to compare treatment effects between the enfuvirtide and control groups by different factors after 48 weeks that were carried out are discussed. It was demonstrated that the efficacy to enfuvirtide is durable plus optimized background over 48 weeks.

Published
2005

49. Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America

Author

Lalezari, Jacob P., Trottier, Benoit, Jain Chung, Salgo, Miklos, Henry, Keith, Walmsley, Sharon, DeMasi, Ralph, O'Hearn, Mary, Cohen, Calvin, Donatacci, Lucille, Montaner, Julio S.G., Kuritzkes, Daniel R., Drobnes, Claude, Piliero, Peter J., Eron, Joseph J., Jr., and Delehanty, John

Subjects
Highly active antiretroviral therapy -- Research, HIV patients -- Research, HIV infection -- Research, HIV infection -- Care and treatment, United States -- Health aspects
Abstract

A randomized, open-label, phase 3 study of enfuvirtide (T-20), a human immunodeficiency virus type 1 (HIV-1) fusion inhibitor was conducted through the T-20 vs. Optimized Regimen Only Study 1 (TORO 1). It was concluded that the addition of enfuvirtide to an optimized antiretroviral regimen provided significant antiretroviral and immunologic benefit through 24 weeks in patients who had previously received multiple antiretroviral drugs and had multidrug-resistant HIV-1 infection.

Published
2003

50. A randomized controlled trial of a replication defective (gH deletion) herpes simplex virus vaccine for the treatment of recurrent genital herpes among immunocompetent subjects

Author

de Bruyn, Guy, Vargas-Cortez, Mauricio, Warren, Terri, Tyring, Stephen K., Fife, Kenneth H., Lalezari, Jacob, Brady, Rebecca C., Shahmanesh, Mohsen, Kinghorn, George, Beutner, Karl R., Patel, Rajul, Drehobl, Margaret A., Horner, Patrick, Kurtz, Terrance O., McDermott, Sharon, Wald, Anna, and Corey, Lawrence

Published
2006
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