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1. 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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2. Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial

Author

Fichtenbaum, Carl J, Ribaudo, Heather J, Leon-Cruz, Jorge, Overton, Edgar T, Zanni, Markella V, Malvestutto, Carlos D, Aberg, Judith A, Kileel, Emma M, Fitch, Kathleen V, Van Schalkwyk, Marije, Kumarasamy, Nagalingeswaran, Martinez, Esteban, Santos, Breno Riegel, Joseph, Yvetot, Lo, Janet, Siminski, Sue, Melbourne, Kathleen, Sponseller, Craig A, Desvigne-Nickens, Patrice, Bloomfield, Gerald S, Currier, Judith S, Hoffmann, Udo, Douglas, Pamela S, Grinspoon, Steven K, Curran, Adrian, Baranauskas, Adrienne, Wilkin, Aimee, Abrams-Downey, Alexandra J, Eckard, Allison Ross, Wurcel, Alysse G, González-Cordón, Ana, Paez, Armando, Sha, Beverly E, Santos, Breno, Yoshida, Carina Beppu, Rolle, Charlotte-Paige, Somboonwit, Charurut, Funk, Connie, Gómez-Ayerbe, Cristina, Frank, Cynthia, Nixon, Daniel E, Skiest, Daniel J, Choi, David, Mushatt, David M, Rial-Crestelo, David, Perez, Deborah K, Burke, Deirdre J, dos Santos, Desirée VG, Jayaweera, Dushyantha T, Gardner, Edward M, DeJesus, Edwin, Connick, Elizabeth, Lam, Emerline G, Hecker, Emily J, Kallas, Esper G, Waters, Evan, Rhame, Frank, Sattler, Fred R, Wang, Gary P, Enrile Seedhom, Helen May, Tavares, Isabel CF, Stapleton, Jack T, Bennet, Jaclyn, Brock, James B, Scott, James, Forcht, Janet, Lama, Javier R, Valencia, Javier, Brumfield, Jennifer K, Portilla, Joaquin, Kumar, Jonathan, Navarro, Jordi, Pinto, Jorge A, Castro, Jose G, Bernardino, Jose I, Casado, Jose L, Madruga, José Valdez, Baraiaetxaburu, Josu, Berenguer, Juan, Tashima, Karen T, Ho, Ken, Costa, Laura VL, Perez Latorre, Leire, Mohapi, Lerato, López-González, L, Fantry, Lori E, Domínguez-Domínguez, Lourdes, Martín-Carbonero, Luz, Cornelissen, Lynne M, Jain, Mamta K, Masiá, Mar, Lacerda, Marcus VG, Saumoy, Maria, Villalobos-Hernández, Marina, and Mall, Mark

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Sexually Transmitted Infections, HIV/AIDS, Clinical Trials and Supportive Activities, Clinical Research, Infectious Diseases, 6.1 Pharmaceuticals, Infection, Good Health and Well Being, Adult, Anti-Retroviral Agents, CD4 Lymphocyte Count, CD4-CD8 Ratio, Cross-Sectional Studies, Female, HIV Infections, Humans, Male, Middle Aged, Randomized Controlled Trials as Topic, HIV, statins, pitavastatin calcium, antiretroviral therapy, CD4 cell count, CD4/CD8 ratio, REPRIEVE, cardiovascular disease, REPRIEVE Investigators, Biological Sciences, Medical and Health Sciences, Microbiology, Biological sciences, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundPatterns of antiretroviral therapy (ART) use and immunologic correlates vary globally, and contemporary trends are not well described.MethodsThe REPRIEVE trial (Randomized Trial to Prevent Vascular Events in HIV) enrolled persons with human immunodeficiency virus (HIV) who were aged 40-75 years, receiving ART, and had low-to-moderate cardiovascular disease risk. ART use was summarized within Global Burden of Disease (GBD) super-regions, with adjusted linear and logistic regression analyses examining associations with immune parameters and key demographics.ResultsA total of 7770 participants were enrolled, with a median age of 50 years (interquartile range, 45-55 years); 31% were female, 43% were black or African American, 15% were Asian, 56% had a body mass index >25 (calculated as weight in kilograms divided by height in meters squared), and 49% were current or former smokers. The median CD4 T-cell count was 620/µL (interquartile range, 447-826/ µ L), and the median duration of prior ART use, 9.5 years (5.3-14.8) years. The most common ART regimens were nucleoside/nucleotide reverse-transcriptase inhibitor (NRTI) plus nonnucleoside reverse-transcriptase inhibitor (43%), NRTI plus integrase strand transfer inhibitor (25%), and NRTI plus protease inhibitor (19%). Entry ART varied by GBD region, with shifts during the trial enrollment period. In adjusted analyses, entry CD4 cell count and CD4/CD8 ratio were associated with GBD region, sex, entry regimen, duration of ART, and nadir CD4 cell count; CD4 and CD8 cell counts were also associated with body mass index and smoking status.ConclusionsThere were substantial variations in ART use by geographic region and over time, likely reflecting the local availability of specific medications, changes in treatment guidelines and provider/patient preferences. The analyses of CD4 cell counts and CD4/CD8 ratios may provide valuable insights regarding immune correlates and outcomes in people living with HIV.Clinical trials registrationNCT02344290.

Published
2020

4. Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomised, double-blind, non-inferiority, phase 3 trial

Author

Hagins, Debbie P., Osiyemi, Olayemi O., Prelutsky, David James, Ramgopal, Moti N., Scarsella, Anthony John, Dretler, Robin, DeJesus, Edwin, Bettacchi, Christopher J., Sims, James, III, Clay, Patrick G., Bellos, Nicholaos C., Thompson, Melanie A., Montero, Jose, McDonald, Cheryl K., Creticos, Catherine, Shamblaw, David, Mogyoros, Miguel, Terrelonge, Antonio E., Valdes, Martin, Tashima, Karen T., Robbins, William J., Felizarta, Franco Antonio, Elion, Richard A., Slim, Jihad, Win, Sandra S., Lalla-Reddy, Sujata N., Ruane, Peter Jerome, Mills, Anthony, Cade, Jerry L., Dietz, Craig A., Rubin, David Scott, Mayer, Cynthia, Rondon, Juan Carlos, Cook, Paul P., Daar, Eric, Kumar, Princy N., Swindells, Susan, Castro, Jose Guillermo, Melendez-Rivera, Ivan, Morales-Ramirez, Javier O., Santiago, Lizette, Santana-Bagur, Jorge L., 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, Maria Isabel, 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, de Jager, Marleen, Portilla Segorb, Joaquin, Mallolas, Josep, Perez Elias, Maria Jesus, Gatell, Josep M., Arribas Lopez, Jose Ramon, Negredo Puigmal, Eugenia, Podzamczer Palter, Daniel, Pulido Ortega, Federico, Troya Garcia, Jesus, De los Santos Gil, Ignacio, Berenguer Berenguer, Juan, Williams, Ian G., Johnson, Margaret A., Schembri, Gabriel, Clarke, Amanda, Gompels, Mark, Fox, Julie Meriel, Taylor, Steven John, Dockrell, David Harold, Kegg, Stephen, Squires, Kathleen, Sax, Paul E, Cahn, Pedro, Lombaard, Johan, Lai, Ming-Tain, Rodgers, Anthony, Lupinacci, Lisa, Kumar, Sushma, Sklar, Peter, Hanna, George J, Hwang, Carey, and Martin, Elizabeth Anne

Published
2020
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6. ING116070: A Study of the Pharmacokinetics and Antiviral Activity of Dolutegravir in Cerebrospinal Fluid in HIV-1–Infected, Antiretroviral Therapy–Naive Subjects

Author

Letendre, Scott L, Mills, Anthony M, Tashima, Karen T, Thomas, Deborah A, Min, Sherene S, Chen, Shuguang, Song, Ivy H, and Piscitelli, Stephen C

Subjects
Medical Microbiology, Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Sexually Transmitted Infections, HIV/AIDS, Neurosciences, Clinical Research, Infectious Diseases, 6.1 Pharmaceuticals, 5.1 Pharmaceuticals, Infection, Adult, Anti-HIV Agents, Cerebrospinal Fluid, Dideoxynucleosides, Drug Combinations, HIV Infections, HIV-1, Heterocyclic Compounds, 3-Ring, Humans, Lamivudine, Male, Middle Aged, Oxazines, Piperazines, Plasma, Pyridones, RNA, Viral, Treatment Outcome, Viral Load, extended ING116070 study team, HIV, cerebrospinal fluid, dolutegravir, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

BackgroundDolutegravir (DTG), a once-daily, human immunodeficiency virus type 1 (HIV-1) integrase inhibitor, was evaluated for distribution and antiviral activity in cerebrospinal fluid (CSF).MethodsING116070 is an ongoing, single-arm, open-label, multicenter study in antiretroviral therapy-naive, HIV-1-infected adults. Subjects received DTG (50 mg) plus abacavir/lamivudine (600/300 mg) once daily. The CSF and plasma (total and unbound) DTG concentrations were measured at weeks 2 and 16. The HIV-1 RNA levels were measured in CSF at baseline and weeks 2 and 16 and in plasma at baseline and weeks 2, 4, 8, 12, and 16.ResultsThirteen white men enrolled in the study; 2 withdrew prematurely, 1 because of a non-drug-related serious adverse event (pharyngitis) and 1 because of lack of treatment efficacy. The median DTG concentrations in CSF were 18 ng/mL (range, 4-23 ng/mL) at week 2 and 13 ng/mL (4-18 ng/mL) at week 16. Ratios of DTG CSF to total plasma concentration were similar to the unbound fraction of DTG in plasma. Median changes from baseline in CSF (n = 11) and plasma (n = 12) HIV-1 RNA were -3.42 and -3.04 log10 copies/mL, respectively. Nine of 11 subjects (82%) had plasma and CSF HIV-1 RNA levels

Published
2014

8. 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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9. Safety, acceptability, and pharmacokinetics of a monoclonal antibody-based vaginal multipurpose prevention film (MB66): A Phase I randomized trial

Author

Politch, Joseph A., Cu-Uvin, Susan, Moench, Thomas R., Tashima, Karen T., Marathe, Jai G., Guthrie, Kate M., Cabral, Howard, Nyhuis, Tara, Brennan, Miles, Zeitlin, Larry, Spiegel, Hans M. L., Mayer, Kenneth H., Whaley, Kevin J., and Anderson, Deborah J.

Subjects
Pharmacokinetics -- Research, Pharmacology, Experimental, Sexually transmitted diseases -- Prevention, Herpes -- Prevention, Monoclonal antibodies -- Dosage and administration, Vagina, Medication by -- Dosage and administration, Herpesvirus diseases -- Prevention, HIV infection -- Prevention, Biological sciences
Abstract

Background MB66 film is a multipurpose prevention technology (MPT) product with monoclonal antibodies (mAbs) against HIV-1 (VRC01-N) and HSV-1 and 2 (HSV8-N). The mAbs were produced by transient expression in Nicotiana benthamiana (N). We conducted a Phase I clinical trial to assess the safety, pharmacokinetics (PK), and ex vivo efficacy of single and repeated doses of MB66 when used intravaginally. Methods and findings The clinical trial enrolled healthy reproductive-aged, sexually abstinent women. In Segment A, 9 women received a single MB66 film which was inserted into the vaginal posterior fornix by a clinician. In Segment B, 29 women were randomly assigned to MB66 (Active) or Placebo film groups and were instructed to insert 1 film vaginally for 7 consecutive days. Visits and clinical sampling occurred predose and at various time points after single and repeated film doses. The primary endpoint was number of adverse events (AEs) Grade 2 or higher related to product use. Secondary endpoints included film dissolution rate, Nugent score (a Gram stain scoring system to diagnose bacterial vaginosis), vaginal pH, post-use survey results, cytokine concentrations in cervicovaginal lavage (CVL) specimens (assessed by Luminex assay), mAb concentrations in vaginal fluid collected from 4 sites (assessed by ELISA), and HIV and HSV neutralization activity of CVL samples ex vivo (assessed by TZM-bl and plaque reduction assay, respectively). The product was generally safe and well tolerated, with no serious AEs recorded in either segment. The AEs in this study were primarily genitourinary in nature with the most commonly reported AE being asymptomatic microscopic hematuria. There were no differences in vaginal pH or Nugent scores or significant increases in levels of proinflammatory cytokines for up to 7 days after film insertion in either segment or between Active and Placebo groups. Acceptability and willingness to use the product were judged to be high by post-use surveys. Concentrations of VRC01-N and HSV8-N in vaginal secretions were assessed over time to generate pharmacokinetic curves. Antibody levels peaked 1 hour postdosing with Active film (median: 35 [mu]g/mL) and remained significantly elevated at 24 hours post first and seventh film (median: 1.8 [mu]g/mL). Correcting for sample dilution (1:20), VRC01-N concentrations ranged from 36 to 700 [mu]g/mL at the 24-hour time point, greater than 100-fold the IC.sub.50 for VRC01 (0.32 [mu]g/mL); HSV8-N concentrations ranged from 80 to 601 [mu]g/mL, well above the IC.sub.50 of 0.1 [mu]g/m. CVL samples collected 24 hours after MB66 insertion significantly neutralized both HIV-1 and HSV-2 ex vivo. Study limitations include the small size of the study cohort, and the fact that no samples were collected between 24 hours and 7 days for pharmacokinetic evaluation. Conclusions Single and repeated intravaginal applications of MB66 film were safe, well tolerated, and acceptable. Concentrations and ex vivo bioactivity of both mAbs in vaginal secretions were significantly elevated and thus could provide protection for at least 24 hours postdose. However, further research is needed to evaluate the efficacy of MB66 film in women at risk for HIV and HSV infection. Additional antibodies could be added to this platform to provide protection against other sexually transmitted infections (STIs) and contraception. Trial registration ClinicalTrials.gov NCT02579083., Author(s): Joseph A. Politch 1,*, Susan Cu-Uvin 2, Thomas R. Moench 3, Karen T. Tashima 4, Jai G. Marathe 1, Kate M. Guthrie 5, Howard Cabral 6, Tara Nyhuis 3, [...]

Published
2021
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10. 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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25. Sex differences in atazanavir pharmacokinetics and associations with time to clinical events: AIDS Clinical Trials Group Study A5202

Author

Venuto, Charles S., Mollan, Katie, Ma, Qing, Daar, Eric S., Sax, Paul E., Fischl, Margaret, Collier, Ann C., Smith, Kimberly Y., Tierney, Camlin, Morse, Gene D., Bolivar, Hector H., Navarro, Sandra, Koletar, Susan L., Gochnour, Diane, Seefried, Edward, Hoffman, Julie, Feinberg, Judith, Saemann, Michelle, Patterson, Kristine, Pittard, Donna, Currin, David, Upton, Kerry, Saag, Michael, Ray, Graham, Johnson, Steven, Santos, Bartolo, Funk, Connie A., Morgan, Michael, Jackson, Brenda, Tebas, Pablo, Thomas, Aleshia, Kim, Ge-Youl, Klebert, Michael K., Santana, Jorge L., Marrero, Santiago, Norris, Jane, Valle, Sandra, Cox, Gary Matthew, Silberman, Martha, Shaik, Sadia, Lopez, Ruben, Vasquez, Margie, Daskalakis, Demetre, Megill, Christina, Stroberg, Todd, Shore, Jessica, Taiwo, Babafemi, Goldman, Mitchell, Boston, Molly, Lennox, Jeffrey, del Rio, Carlos, Lane, Timothy W., Epperson, Kim, Luetkemeyer, Annie, Payne, Mary, Gripshover, Barbara, Antosh, Dawn, Reid, Jane, Adams, Mary, Storey, Sheryl S., Dunaway, Shelia B., Gallant, Joel, Wiggins, Ilene, Smith, Kimberly Y., Swiatek, Joan A., Timpone, Joseph, Kumar, Princy, Moe, Ardis, Palmer, Maria, Gothing, Jon, Delaney, Joanne, Whitely, Kim, Anderson, Ann Marie, Hammer, Scott M., Yin, Michael T., Jain, Mamta, Petersen, Tianna, Corales, Roberto, Hurley, Christine, Henry, Keith, Bordenave, Bette, Youmans, Amanda, Albrecht, Mary, Pollard, Richard B., Olusanya, Abimbola, Skolnik, Paul R., Adams, Betsy, Tashima, Karen T., Patterson, Helen, Ukwu, Michelle, Rogers, Lauren, Balfour, Henry H., Jr, Fox, Kathy A., Swindells, Susan, Van Meter, Frances, Robbins, Gregory, Burgett-Yandow, Nicole, Davis, Charles E., Jr, Boyce, Colleen, OʼBrien, William A., Casey, Gerianne, Morse, Gene D., Hsaio, Chiu-Bin, Meier, Jeffrey L., Stapleton, Jack T., Mildvan, Donna, Revuelta, Manuel, Currin, David, El Sadr, Wafaa, Loquere, Avelino, El-Daher, Nyef, Johnson, Tina, Gross, Robert, Maffei, Kathyrn, Hughes, Valery, Sturge, Glenn, McMahon, Deborah, Rutecki, Barbara, Wulfsohn, Michael, Cheng, Andrew, Bischofberger, Norbert, Dix, Lynn, and Liao, Qiming

Published
2014
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28. Metabolic effects of protease inhibitor-sparing antiretroviral regimens given as initial treatment of HIV-1 infection (AIDS clinical trials group study A5095)

Author

Shikuma, Cecilia M., Yang Yang, Glesby, Marshall J., Meyer, William A., III, Tashima, Karen T., Ribaudo, Heather J., Webb, Nancy, Bastow, Barbara, Kuritzkes, Daniel R., and Gulick, Roy M.

Subjects
HIV infection -- Care and treatment, Protease inhibitors -- Complications and side effects, Drug metabolism -- Research, Health
Abstract

Metabolic changes are assessed after initiation of protease inhibitor (PI)-sparing regimes in antiretroviral-naive patients. The results have shown mild increases in glucose and decreases in insulin sensitivity in all regimens, whereas lipids are modestly higher in the 3-drug efavirenz (EFV)-containing arms and the metabolic dysfunctions of concern after the PI-sparing therapies are abnormal total cholesterol (TC) and lower high-density lipoprotein cholesterol (HDL-C) levels.

Published
2007

29. Antiretroviral medication considerations for individuals coinfected with HIV and hepatitis C virus

Author

Lai, Andrew R., Tashima, Karen T., and Taylor, Lynn E.

Subjects
Antiviral agents -- Health aspects, Hepatitis C virus -- Drug therapy, HIV infection -- Drug therapy, Health
Abstract

There is great need to treat HIV/hepatitis C virus (HCV)-coinfected individuals with both antiretroviral and anti-HCV pharmacotherapy. However, treatment for HIV may lead to hepatotoxicity, and there are potential interactions and synergistic effects between antiretrovirals and anti-HCV medications. The ideal antiretroviral therapy options for coinfected patients, in the setting of anti-HCV treatment, are unclear and present important challenges to clinicians. We review the current data on the use of antiretrovirals in HIV/HCV-coinfected patients and offer evidence-based recommendations on optimal selection and dosing of antiretroviral agents for this population.

Published
2006

31. Guidelines for the management of chronic kidney disease in HIV-infected patients: recommendations of the HIV medicine association of the Infectious Diseases Society of America

Author

Gupta, Samir K., Eustace, Joseph A., Winston, Jonathan A., Boydstun, Ivy I., Ahuja, Tejinder S., Rodriguez, Rudolph A., Tashima, Karen T., Roland, Michelle, Franceschini, Nora, Palella, Frank J., Lennox, Jeffrey L., Klotman, Paul E., Nachman, Sharon A., Hall, Stephen D., and Szczech, Lynda A.

Subjects
HIV infection -- Diagnosis, HIV infection -- Care and treatment, Kidney diseases -- Diagnosis, Kidney diseases -- Care and treatment, Health, Health care industry
Published
2005

32. Guidelines for the evaluation and management of dyslipidemia in human immunodeficiency virus (HIV)-infected adults receiving antiretroviral therapy: recommendations of the HIV medicine association of the infectious disease society of America and the adult AIDS clinical trials group

Author

Dube, Michael P., Stein, James H., Aberg, Judith A., Fichtenbaum, Carl J., Gerber, John G., Tashima, Karen T., Henry, W. Keith, Currier, Judith S., Sprecher, Dennis, and Glesby, Marshall J.

Subjects
Clinical trials -- Analysis, Blood cholesterol -- Health aspects, Blood cholesterol -- Physiological aspects, Lipid metabolism disorders -- Health aspects, Lipid metabolism disorders -- Causes of, Antiviral agents -- Physiological aspects, HIV (Viruses) -- Health aspects, HIV (Viruses) -- Care and treatment, HIV (Viruses) -- Complications, HIV patients -- Health aspects, HIV patients -- Care and treatment, Communicable diseases -- Research, Communicable diseases -- Health aspects, Health, Health care industry
Published
2003

33. Response to lamivudine-zidovudine plus abacavir twice daily in antiretroviral-naive, incarcerated patients with HIV infection taking directly observed treatment. (Major Article)

Author

Kirkland, Larry R., Fischl, Margaret A., Tashima, Karen T., Paar, David, Gensler, Thomas, Graham, Neil M., Gao, Haitao, Carranza Rosenzweig, Jacqueline R., McClernon, Daniel R., Pittman, Ginger, Hessenthaler, Siegrid M., and Hernandez, Jaime E.

Subjects
HIV infection -- Drug therapy, Prisoners -- Diseases, Health, Health care industry
Published
2002

34. Plateau in body habitus changes and serum lipid abnormalities in HIV-positive women on highly active antiretroviral therapy: a 3.5-year study

Author

Mahajan, Anish P., Tashima, Karen T., Bausserman, Linda L., Flynn, Mary M., and Carpenter, Charles C.J.

Subjects
Body composition, HIV infection -- Drug therapy, Lipid metabolism disorders -- Causes of, Health
Abstract

Most changes in body composition in female HIV patients taking highly active antiretroviral therapy (HAART) occur within the first year and usually stabilize after 2.5 years. However, blood levels of fats and cholesterol become elevated, which is a risk factor for cardiovascular disease.

Published
2001

35. Remdesivir for 5 or 10 Days in Patients with Severe Covid-19

Author

Goldman, Jason D., primary, Lye, David C.B., additional, Hui, David S., additional, Marks, Kristen M., additional, Bruno, Raffaele, additional, Montejano, Rocio, additional, Spinner, Christoph D., additional, Galli, Massimo, additional, Ahn, Mi-Young, additional, Nahass, Ronald G., additional, Chen, Yao-Shen, additional, SenGupta, Devi, additional, Hyland, Robert H., additional, Osinusi, Anu O., additional, Cao, Huyen, additional, Blair, Christiana, additional, Wei, Xuelian, additional, Gaggar, Anuj, additional, Brainard, Diana M., additional, Towner, William J., additional, Muñoz, Jose, additional, Mullane, Kathleen M., additional, Marty, Francisco M., additional, Tashima, Karen T., additional, Diaz, George, additional, and Subramanian, Aruna, additional

Published
2020
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36. 548. Baseline characteristics associated with clinical improvement and mortality in hospitalized patients with moderate COVID-19

Author

Castagna, Antonella, primary, Hui, David Shu Cheong, additional, Mullane, Kathleen M, additional, Jain, Mamta, additional, Galli, Massimo, additional, Chang, Shan-Chwen, additional, Hyland, Robert H, additional, SenGupta, Devi, additional, Cao, Huyen, additional, Huang, Hailin, additional, Chokkalingam, Anand, additional, Osinusi, Anu, additional, Brainard, Diana M, additional, Lübbert, Christoph, additional, Lye, David Chien Boon, additional, Aberg, Judith A, additional, Elorza, Enrique Navas, additional, Tashima, Karen T, additional, and McPhail, Mark, additional

Published
2020
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37. 72. Remdesivir vs Standard Care in Patients with Moderate covid-19

Author

Marty, Francisco M, primary, Malhotra, Prashant, additional, Gottlieb, Robert L, additional, Tashima, Karen T, additional, Galli, Massimo, additional, Chai, Louis Yi Ann, additional, SenGupta, Devi, additional, Hyland, Robert H, additional, Wang, Hongyuan, additional, Zhong, Lijie, additional, Cao, Huyen, additional, Chokkalingam, Anand, additional, Osinusi, Anu, additional, Brainard, Diana M, additional, Brown, Michael, additional, Goikoetxea, Ane Josune, additional, Jain, Mamta, additional, Hui, David Shu Cheong, additional, Bernasconi, Enos, additional, and Spinner, Christoph, additional

Published
2020
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38. 73. Geographical Disparities in Clinical Outcomes of Severe COVID-19 Patients Treated with Remdesivir

Author

Diaz, George, primary, Arribas, Jose Ramon, additional, Robinson, Philip A, additional, Cattelan, Anna Maria, additional, Tashima, Karen T, additional, Tsang, Owen Tak-Yin, additional, Chen, Yao-Shen, additional, SenGupta, Devi, additional, Vendrame, Elena, additional, Blair, Christiana, additional, Chokkalingam, Anand, additional, Osinusi, Anu, additional, Brainard, Diana M, additional, Chin, Bum Sik, additional, Spinner, Christoph, additional, Criner, Gerard J, additional, Muñoz, Jose, additional, Lye, David Chien Boon, additional, and Gottlieb, Robert L, additional

Published
2020
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39. 557. Impact of Concomitant Hydroxychloroquine Use on Safety and Efficacy of Remdesivir in Moderate COVID-19 Patients

Author

Arribas, Jose Ramon, primary, Arribas, Jose Ramon, additional, Sanyal, Arun J, additional, Soriano, Alex, additional, Chin, Bum Sik, additional, Kalimuddin, Shirin, additional, Schreiber, Stefan, additional, Elboudwarej, Emon, additional, Tian, Yuan, additional, Hyland, Robert H, additional, SenGupta, Devi, additional, Chokkalingam, Anand, additional, Osinusi, Anu, additional, Brainard, Diana M, additional, Lübbert, Christoph, additional, Lye, David Chien Boon, additional, Aberg, Judith A, additional, Elorza, Enrique Navas, additional, Tashima, Karen T, additional, and McPhail, Mark, additional

Published
2020
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40. Remdesivir Use Compared With Supportive Care in Hospitalized Patients With Severe COVID-19: A Single-Center Experience

Author

Kalligeros, Markos, primary, Tashima, Karen T, additional, Mylona, Evangelia K, additional, Rybak, Natasha, additional, Flanigan, Timothy P, additional, Farmakiotis, Dimitrios, additional, Beckwith, Curt G, additional, Sanchez, Martha, additional, Neill, Marguerite, additional, Johnson, Jennie E, additional, Garland, Joseph M, additional, Aung, Su, additional, Byrd, Katrina M, additional, O’Brien, Thomas, additional, Pandita, Aakriti, additional, Aridi, Jad, additional, Macias Gil, Raul, additional, Larkin, Jerome, additional, Shehadeh, Fadi, additional, and Mylonakis, Eleftherios, additional

Published
2020
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41. Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults

Author

Staszewski, Schlomo, Morales-Ramirez, Javier, Tashima, Karen T., Rachlis, Anita, Skiest, Daniel, Stanford, James, Stryker, Richard, Johnson, Philip, American architect, Labriola, Dominic F., Farina, Dianne, Manion, Douglas J., and Ruiz, Nancy M.

Subjects
HIV infection -- Drug therapy
Abstract

The AIDS drug efavirenz combined with the drugs zidovudine and lamivudine appears to be more effective in treating HIV infection than other drug combinations, including protease inhibitors. Researchers randomly assigned 450 HIV patients to take one of three drug combinations: efavirenz with either the protease inhibitor indinavir or zidovudine and lamivudine, or zidovudine, lamivudine, and indinavir. Patients who received efavirenz, zidovudine and lamivudine were more likely to achieve undetectable blood viral levels than patients in the other groups. These patients were also less likely to have side effects from the drugs.

Published
1999

42. Changes in body habitus and serum lipid abnormalities in HIV-positive women on highly active antiretroviral therapy (HAART)

Author

Dong, Krista L., Bausserman, Linda L., Flynn, Mary M., Dickinson, Brian P., Flanigan, Timothy P., Mileno, Maria D., Tashima, Karen T., and Carpenter, Charles C.J.

Subjects
Antiviral agents -- Adverse and side effects, Fat metabolism, HIV infection -- Drug therapy, Health
Abstract

Highly active antiretroviral therapy (HAART) can have adverse effects on blood lipids that can increase the patient's risk of heart disease. This was seen in a study of 21 women who developed abnormal fat deposits and elevated cholesterol levels.

Published
1999

43. Remdesivir for 5 or 10 Days in Patients With Severe Covid-19

Author

Goldman, Jason D., Lye, David C.B., Hui, David S., Marks, Kristen M., Bruno, Raffaele, Montejano, Rocio, Spinner, Christoph D., Galli, Massimo, Ahn, Mi‑Young, Nahass, Ronald G., Chen, Yao-Shen, SenGupta, Devi, Hyland, Robert H., Osinusi, Anu O., Cao, Huyen, Blair, Christiana, Wei, Xuelian, Gaggar, Anuj, Brainard, Diana M., Towner, William J., Muñoz Gutiérrez, José, Mullane, Kathleen M., Marty, Francisco M., Tashima, Karen T., Diaz, George, Subramanian, Aruna, and GS-US-540-5773 Investigators

Subjects
Adult, Male, Adenosine monophosphate, Coronavirus disease 2019 (COVID-19), Pneumonia, Viral, 030204 cardiovascular system & hematology, Pharmacology, Antiviral Agents, Drug Administration Schedule, Betacoronavirus, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Clinical trials, Humans, Medicine, In patient, 030212 general & internal medicine, Pandemics, Aged, Alanine, biology, SARS-CoV-2, business.industry, Oxygen Inhalation Therapy, COVID-19, General Medicine, Middle Aged, medicine.disease, biology.organism_classification, Adenosine Monophosphate, In vitro, COVID-19 Drug Treatment, Hospitalization, Clinical trial, Pneumonia, Treatment Outcome, Editorial, chemistry, RNA Polymerase Inhibitor, Original Article, Female, Coronavirus Infections, business, Assaigs clínics
Abstract

Background Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19). Methods We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale. Results In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P=0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P=0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%). Conclusions In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.)

Published
2020

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