Search Results - "SPREEN, William"

Exploring predictors of HIV-1 virologic failure to long-acting cabotegravir and rilpivirine: a multivariable analysis by Cutrell, Amy G., Schapiro, Jonathan M., Perno, Carlo F., Kuritzkes, Daniel R., Quercia, Romina, Patel, Parul, Polli, Joseph W., Dorey, David, Wang, Yongwei, Wu, Sterling, Van Eygen, Veerle, Crauwels, Herta, Ford, Susan L., Baker, Mark, Talarico, Christine L., Clair, Marty St, Jeffrey, Jerry, White, C. Thomas, Vanveggel, Simon, Vandermeulen, Kati, Margolis, David A., Aboud, Michael, Spreen, William R., van Lunzen, Jan

“…Efficacy and safety of long-acting cabotegravir (CAB) and rilpivirine (RPV) dosed intramuscularly every 4 or 8 weeks has been demonstrated in three Phase 3…”
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Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial by Margolis, David A, Gonzalez-Garcia, Juan, Stellbrink, Hans-Jürgen, Eron, Joseph J, Yazdanpanah, Yazdan, Podzamczer, Daniel, Lutz, Thomas, Angel, Jonathan B, Richmond, Gary J, Clotet, Bonaventura, Gutierrez, Felix, Sloan, Louis, Clair, Marty St, Murray, Miranda, Ford, Susan L, Mrus, Joseph, Patel, Parul, Crauwels, Herta, Griffith, Sandy K, Sutton, Kenneth C, Dorey, David, Smith, Kimberly Y, Williams, Peter E, Spreen, William R

“…Cabotegravir and rilpivirine are antiretroviral drugs in development as long-acting injectable formulations. The LATTE-2 study evaluated long-acting…”
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Cabotegravir plus rilpivirine, once a day, after induction with cabotegravir plus nucleoside reverse transcriptase inhibitors in antiretroviral-naive adults with HIV-1 infection (LATTE): a randomised, phase 2b, dose-ranging trial by Margolis, David A, Dr, Brinson, Cynthia C, MD, Smith, Graham H R, MD, de Vente, Jerome, MD, Hagins, Debbie P, MD, Eron, Joseph J, Prof, Griffith, Sandy K, PharmD, Clair, Marty H St, BS, Stevens, Marita C, MD, Williams, Peter E, PhD, Ford, Susan L, PharmD, Stancil, Britt S, BS, Bomar, Melinda M, BS, Hudson, Krischan J, PhD, Smith, Kimberly Y, MD, Spreen, William R, PharmD

“…Summary Background In phase 1 trials, the HIV-1 integrase strand transfer inhibitor cabotegravir (GSK1265744) was well tolerated, both alone, and in…”
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Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial by Landovitz, Raphael J, Li, Sue, Grinsztejn, Beatriz, Dawood, Halima, Liu, Albert Y, Magnus, Manya, Hosseinipour, Mina C, Panchia, Ravindre, Cottle, Leslie, Chau, Gordon, Richardson, Paul, Marzinke, Mark A, Hendrix, Craig W, Eshleman, Susan H, Zhang, Yinfeng, Tolley, Elizabeth, Sugarman, Jeremy, Kofron, Ryan, Adeyeye, Adeola, Burns, David, Rinehart, Alex R, Margolis, David, Spreen, William R, Cohen, Myron S, McCauley, Marybeth, Eron, Joseph J

“…Cabotegravir (CAB) is a novel strand-transfer integrase inhibitor being developed for HIV treatment and prevention. CAB is formulated both as an…”
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Long-acting injectable antiretrovirals for HIV treatment and prevention by Spreen, William R, Margolis, David A, Pottage, John C

“…PURPOSE OF REVIEWLong-acting antiretroviral (ARV) drugs may improve adherence to therapy and extend opportunities for therapeutic or prophylactic intervention…”
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Long-Acting Integrase Inhibitor Protects Macaques from Intrarectal Simian/Human Immunodeficiency Virus by Andrews, Chasity D., Spreen, William R., Mohri, Hiroshi, Moss, Lee, Ford, Susan, Gettie, Agegnehu, Russell-Lodrigue, Kasi, Bohm, Rudolf P., Cheng-Mayer, Cecilia, Hong, Zhi, Markowitz, Martin, Ho, David D.

“…GSK1265744 (GSK744) is an integrase strand-transfer inhibitor that has been formulated as a long-acting (LA) injectable suitable for monthly to quarterly…”
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Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment by Swindells, Susan, Lutz, Thomas, Van Zyl, Lelanie, Porteiro, Norma, Stoll, Matthias, Mitha, Essack, Shon, Alyssa, Benn, Paul, Huang, Jenny O., Harrington, Conn M., Hove, Kai, Ford, Susan L., Talarico, Christine L., Chounta, Vasiliki, Crauwels, Herta, Van Solingen-Ristea, Rodica, Vanveggel, Simon, Margolis, David A., Smith, Kimberly Y., Vandermeulen, Kati, Spreen, William R.

“…ATLAS (NCT02951052), a phase 3, multicenter, open-label study, demonstrated that switching to injectable cabotegravir (CAB) with rilpivirine (RPV) long-acting…”
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Safety, Tolerability, Pharmacokinetics, and Acceptability of Oral and Long-Acting Cabotegravir in HIV-Negative Chinese Men by Han, Kelong, Wannamaker, Paul, Lu, Hongzhou, Zhu, Biao, Wang, Meixia, Paff, Melanie, Spreen, William R, Ford, Susan L

“…Long-acting (LA) cabotegravir demonstrated superior efficacy versus daily oral standard-of-care for HIV-1 preexposure prophylaxis. This phase 1 study assessed…”
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Pharmacokinetics and tolerability of cabotegravir and rilpivirine long-acting intramuscular injections to the vastus lateralis (lateral thigh) muscles of healthy adult participants by Han, Kelong, Gevorkyan, Hakop, Sadik Shaik, Jafar, Crauwels, Herta, Leemereise, Claudia, Bontempo, Gilda, Win, Beta, Chounta, Vasiliki, Seal, Ciara, DeMoor, Rebecca, D'Amico, Ronald, Spreen, William R, Ford, Susan L

“…Cabotegravir + rilpivirine administered via intramuscular gluteal injections is the first complete long-acting (LA) regimen approved for maintaining HIV-1…”
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Long-Acting Cabotegravir and Rilpivirine Dosed Every 2 Months in Adults With Human Immunodeficiency Virus 1 Type 1 Infection: 152-Week Results From ATLAS-2M, a Randomized, Open-Label, Phase 3b, Noninferiority Study by Overton, Edgar T, Richmond, Gary, Rizzardini, Giuliano, Thalme, Anders, Girard, Pierre-Marie, Wong, Alexander, Porteiro, Norma, Swindells, Susan, Reynes, Jacques, Noe, Sebastian, Harrington, Conn, Español, Carlos Martín, Acuipil, Carolina, Aksar, Asma, Wang, Yuanyuan, Ford, Susan L, Crauwels, Herta, van Eygen, Veerle, Van Solingen-Ristea, Rodica, Latham, Christine L, Thiagarajah, Shanker, D’Amico, Ronald, Smith, Kimberly Y, Vandermeulen, Kati, Spreen, William R

“…Abstract Background Cabotegravir (CAB) + rilpivirine (RPV) dosed intramuscularly monthly or every 2 months is a complete, long-acting (LA) regimen for the…”
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Safety and tolerability of long-acting cabotegravir injections in HIV-uninfected men (ECLAIR): a multicentre, double-blind, randomised, placebo-controlled, phase 2a trial by Markowitz, Martin, Prof, Frank, Ian, Prof, Grant, Robert M, Prof, Mayer, Kenneth H, Prof, Elion, Richard, MD, Goldstein, Deborah, MD, Fisher, Chester, MD, Sobieszczyk, Magdalena E, MD, Gallant, Joel E, MD, Van Tieu, Hong, MD, Weinberg, Winkler, MD, Margolis, David A, MD, Hudson, Krischan J, PhD, Stancil, Britt S, BS, Ford, Susan L, Pharm D, Patel, Parul, Pharm D, Gould, Elizabeth, BS, Rinehart, Alex R, PhD, Smith, Kimberly Y, MD, Spreen, William R, Pharm D

“…Summary Background Cabotegravir (GSK1265744) is an HIV-1 integrase strand transfer inhibitor with potent antiviral activity and a long half-life when…”
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Population pharmacokinetics of cabotegravir following administration of oral tablet and long‐acting intramuscular injection in adult HIV‐1‐infected and uninfected subjects by Han, Kelong, Baker, Mark, Lovern, Mark, Paul, Prokash, Xiong, Yuan, Patel, Parul, Moore, Katy P., Seal, Ciara S., Cutrell, Amy G., D'Amico, Ronald D., Benn, Paul D., Landovitz, Raphael J., Marzinke, Mark A., Spreen, William R., Ford, Susan L.

“…Aim To characterize cabotegravir population pharmacokinetics using data from phase 1, 2 and 3 studies and evaluate the association of intrinsic and extrinsic…”
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Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy by Mills, Anthony, Richmond, Gary J., Newman, Cheryl, Osiyemi, Olayemi, Cade, Jerry, Brinson, Cynthia, De Vente, Jerome, Margolis, David A., Sutton, Kenneth C., Wilches, Viviana, Hatch, Sarah, Roberts, Jeremy, McCoig, Cynthia, Garris, Cindy, Vandermeulen, Kati, Spreen, William R.

“…Long-acting formulations of cabotegravir (CAB) and rilpivirine (RPV) have demonstrated efficacy in Phase 3 studies. POLAR (NCT03639311) assessed antiviral…”
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Initiation of long-acting cabotegravir plus rilpivirine as direct-to-injection or with an oral lead-in in adults with HIV-1 infection: week 124 results of the open-label phase 3 FLAIR study by Orkin, Chloe, Bernal Morell, Enrique, Tan, Darrell H S, Katner, Harold, Stellbrink, Hans-Jürgen, Belonosova, Elena, DeMoor, Rebecca, Griffith, Sandy, Thiagarajah, Shanker, Van Solingen-Ristea, Rodica, Ford, Susan L, Crauwels, Herta, Patel, Parul, Cutrell, Amy, Smith, Kimberly Y, Vandermeulen, Kati, Birmingham, Eileen, St Clair, Marty, Spreen, William R, D'Amico, Ronald

“…Previous work established non-inferiority of switching participants who were virologically suppressed from daily oral standard of care to monthly long-acting…”
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Long-acting cabotegravir plus rilpivirine for treatment in adults with HIV-1 infection: 96-week results of the randomised, open-label, phase 3 FLAIR study by Orkin, Chloe, Oka, Shinichi, Philibert, Patrick, Brinson, Cynthia, Bassa, Ayesha, Gusev, Denis, Degen, Olaf, García, Juan González, Morell, Enrique Bernal, Tan, Darrell H S, D'Amico, Ronald, Dorey, David, Griffith, Sandy, Thiagarajah, Shanker, St Clair, Marty, Van Solingen-Ristea, Rodica, Crauwels, Herta, Ford, Susan L, Patel, Parul, Chounta, Vasiliki, Vanveggel, Simon, Cutrell, Amy, Van Eygen, Veerle, Vandermeulen, Kati, Margolis, David A, Smith, Kimberly Y, Spreen, William R

“…There is a need for more convenient, less frequent treatment to help address challenges associated with daily oral HIV treatment in people living with HIV,…”
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Lack of Pharmacokinetic Interaction between Rilpivirine and Integrase Inhibitors Dolutegravir and GSK1265744 by FORD, Susan L, GOULD, Elizabeth, SHUGUANG CHEN, MARGOLIS, David, SPREEN, William, CRAUWELS, Herta, PISCITELLI, Stephen

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Pregnancy outcomes and pharmacokinetics in pregnant women living with HIV exposed to long‐acting cabotegravir and rilpivirine in clinical trials by Patel, Parul, Ford, Susan L., Baker, Mark, Meyer, Claudia, Garside, Louise, D'Amico, Ronald, Solingen‐Ristea, Rodica, Crauwels, Herta, Polli, Joseph W., Seal, Ciara, Yagüe Muñoz, Itziar, Thiagarajah, Shanker, Birmingham, Eileen, Spreen, William R., Baugh, Bryan, Wyk, Jean, Vannappagari, Vani

“…Background Limited data exist on pregnant women living with HIV exposed to cabotegravir + rilpivirine (CAB + RPV). Outcomes in pregnant participants exposed to…”
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Expanded Multivariable Models to Assist Patient Selection for Long-Acting Cabotegravir + Rilpivirine Treatment: Clinical Utility of a Combination of Patient, Drug Concentration, and Viral Factors Associated With Virologic Failure by Orkin, Chloe, Schapiro, Jonathan M, Perno, Carlo F, Kuritzkes, Daniel R, Patel, Parul, DeMoor, Rebecca, Dorey, David, Wang, Yongwei, Han, Kelong, Van Eygen, Veerle, Crauwels, Herta, Ford, Susan L, Latham, Christine L, St. Clair, Marty, Polli, Joseph W, Vanveggel, Simon, Vandermeulen, Kati, D’Amico, Ronald, Garges, Harmony P, Zolopa, Andrew, Spreen, William R, van Wyk, Jean, Cutrell, Amy G

“…Abstract Background Previously reported post hoc multivariable analyses exploring predictors of confirmed virologic failure (CVF) with cabotegravir +…”
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A long-acting integrase inhibitor protects female macaques from repeated high-dose intravaginal SHIV challenge by Andrews, Chasity D, Yueh, Yun Lan, Spreen, William R, St Bernard, Leslie, Boente-Carrera, Mar, Rodriguez, Kristina, Gettie, Agegnehu, Russell-Lodrigue, Kasi, Blanchard, James, Ford, Susan, Mohri, Hiroshi, Cheng-Mayer, Cecilia, Hong, Zhi, Ho, David D, Markowitz, Martin

“…Long-acting GSK1265744 (GSK744 LA) is a strand transfer inhibitor of the HIV/SIV (simian immunodeficiency virus) integrase and was shown to be an effective…”
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Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study by Jaeger, Hans, Overton, Edgar T, Richmond, Gary, Rizzardini, Giuliano, Andrade-Villanueva, Jaime Federico, Mngqibisa, Rosie, Hermida, Antonio Ocampo, Thalme, Anders, Belonosova, Elena, Ajana, Faïza, Benn, Paul D, Wang, Yuanyuan, Hudson, Krischan J, Español, Carlos Martín, Ford, Susan L, Crauwels, Herta, Margolis, David A, Talarico, Christine L, Smith, Kimberly Y, van Eygen, Veerle, Van Solingen-Ristea, Rodica, Vanveggel, Simon, Spreen, William R

“…Long-acting cabotegravir and rilpivirine administered monthly or every 2 months might address the challenges associated with daily oral antiretroviral therapy…”
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