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5 results on '"Crauwels P"'

1. Acceptability and tolerability of long-acting injectable cabotegravir or rilpivirine in the first cohort of virologically suppressed adolescents living with HIV (IMPAACT 2017/MOCHA): a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study

Author

Lowenthal, Elizabeth D, Chapman, Jennifer, Ohrenschall, Rachel, Calabrese, Katherine, Baltrusaitis, Kristin, Heckman, Barbara, Yin, Dwight E, Agwu, Allison L, Harrington, Conn, Van Solingen-Ristea, Rodica M, McCoig, Cynthia C, Adeyeye, Adeola, Kneebone, Jared, Chounta, Vasiliki, Smith-Anderson, Christiana, Camacho-Gonzalez, Andres, D'Angelo, Jessica, Bearden, Allison, Crauwels, Herta, Huang, Jenny, Buisson, Sarah, Milligan, Ryan, Ward, Shawn, Bolton-Moore, Carolyn, Gaur, Aditya H, Best, Brookie M, Capparelli, Edmund V, Hanley, Sherika, Mathiba, Sisinyana Ruth, Naidoo, Megeshinee, Ounchanum, Pradthana, Patel, Faeezah, Paul, Mary E, Townley, Ellen, Vandermeulen, Kati, Whitson, Kyle, and Zabih, Sara

Abstract

Long-acting injectable cabotegravir and rilpivirine have demonstrated safety, acceptability, and efficacy in adults living with HIV-1. The IMPAACT 2017 study (MOCHA study) was the first to use these injectable formulations in adolescents (aged 12–17 years) living with HIV-1. Herein, we report acceptability and tolerability outcomes in cohort 1 of the study.

Published
2024
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2. Safety and pharmacokinetics of oral and long-acting injectable cabotegravir or long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study

Author

Gaur, Aditya H, Capparelli, Edmund V, Calabrese, Katherine, Baltrusaitis, Kristin, Marzinke, Mark A, McCoig, Cynthia, Van Solingen-Ristea, Rodica M, Mathiba, Sisinyana Ruth, Adeyeye, Adeola, Moye, John H, Heckman, Barbara, Lowenthal, Elizabeth D, Ward, Shawn, Milligan, Ryan, Samson, Pearl, Best, Brookie M, Harrington, Conn M, Ford, Susan L, Huang, Jenny, Crauwels, Herta, Vandermeulen, Kati, Agwu, Allison L, Smith-Anderson, Christiana, Camacho-Gonzalez, Andres, Ounchanum, Pradthana, Kneebone, Jared L, Townley, Ellen, Bolton Moore, Carolyn, Buisson, Sarah, Cheung, S. Y. Amy, Chounta, Vasiliki, Deprez, Isabelle, Desmond, Alicia Catherine, Han, Kelong, Hanley, Sherika, Lin, Yu-Wei, Patel, Faeezah, Paul, Mary E., Roberts, Gilly, Whitson, Kyle, and Zabih, Sara

Abstract

Combined intramuscular long-acting cabotegravir and long-acting rilpivirine constitute the first long-acting combination antiretroviral therapy (ART) regimen approved for adults with HIV. The goal of the IMPAACT 2017 study (MOCHA [More Options for Children and Adolescents]) was to assess the safety and pharmacokinetics of these drugs in adolescents.

Published
2024
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3. 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

Author

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, and D'Amico, Ronald

Abstract

Previous work established non-inferiority of switching participants who were virologically suppressed from daily oral standard of care to monthly long-acting intramuscular injections of cabotegravir plus rilpivirine over 96 weeks following a cabotegravir plus rilpivirine oral lead-in. Here, we report an evaluation of switching participants from standard of care oral regimens to long-acting cabotegravir plus rilpivirine via direct-to-injection or oral lead-in pathways.

Published
2021
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4. 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

Author

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, and Spreen, William R

Abstract

Long-acting cabotegravir and rilpivirine administered monthly or every 2 months might address the challenges associated with daily oral antiretroviral therapy. The ATLAS-2M week 48 results showed non-inferiority of long-acting cabotegravir and rilpivirine administered every 8 weeks compared with that of every 4 weeks. In this study, we report the efficacy, safety, and tolerability results from the week 96 analysis.

Published
2021
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5. 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

Author

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, and Spreen, William R

Abstract

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, including stigma, pill burden, drug–food interactions, and adherence. The phase 3 ATLAS and FLAIR studies showed non-inferiority of long-acting cabotegravir and rilpivirine dosed every 4 weeks compared with standard oral therapy for the maintenance of virological suppression in adults with HIV-1 over 48 weeks. We present the 96-week findings.

Published
2021
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