10 results on '"Prelutsky, D"'
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2. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials
- Author
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Cahn, P, Madero, J, Arribas, J, Antinori, A, Ortiz, R, Clarke, A, Hung, C, Rockstroh, J, Girard, P, Sievers, J, Man, C, Currie, A, Underwood, M, Tenorio, A, Pappa, K, Wynne, B, Fettiplace, A, Gartland, M, Aboud, M, Smith, K, Cassetti, L, David, D, Figueras, L, Losso, M, Lopardo, G, Lupo, S, Porteiro, N, Sanchez, M, Bloch, M, Cooper, D, Finlayson, R, Kelleher, A, Koh, K, Lewis, D, Mcmahon, J, Moore, R, Roth, N, Shields, M, De Wit, S, Florence, E, Goffard, J, Demeester, R, Lacor, P, Vandercam, B, Vandekerckhove, L, Angel, J, Baril, J, Conway, B, De Pokomandy, A, Szabo, J, Walmsley, S, Bouchaud, O, Chidiac, C, Delobel, P, Goujard, C, Katlama, C, Molina, J, Pialoux, G, Philibert, P, Bogner, J, Esser, S, Krznaric, I, Lehmann, C, Spinner, C, Stellbrink, H, Stephan, C, Stoehr, A, Barchi, E, Caramello, P, Castelli, F, Cattelan, A, D'Arminio Monforte, A, Di Biagio, A, Di Perri, G, Gori, A, Maggiolo, F, Menzaghi, B, Migliorino, G, Mussini, C, Penco, G, Puoti, M, Rizzardini, G, Gulminetti, R, Lazzarin, A, Quirino, T, Sighinolfi, L, Viale, P, Amaya Tapia, G, Andrade Villanueva, J, Granados Reyes, E, Perez Rios, A, Santoscoy Gomez, M, Den Hollander, J, Rijnders, B, Hidalgo, J, Hercilla Vasquez, L, Illescas, L, Olczak, A, Mansinho, K, Correia Pacheco, P, Teofilo, E, Saraiva da Cunha, J, Sarmento e Castro, R, Serrao, R, Arbune, M, Jianu, C, Oprea, A, Preotescu, L, Prisacariu, L, Belonosova, E, Borodkina, O, Chernova, O, Gankina, N, Kizhlo, S, Kulagin, V, Kurina, N, Nagimova, F, Pokrovsky, V, Ryamova, E, Voronin, E, Yakovlev, A, Kaplan, R, Lee, S, Kim, S, Kim, W, Antela Lopez, A, Casado Osorio, J, Castano Carracedo, M, De Los Santos Gil, I, Estrada Perez, V, Falco Ferrer, V, Force, L, Galinda Puerto, M, Garcia Deltoro, M, Gatell, J, Goenaga Sanchez, M, Gonzalez Cordon, A, Knobel, H, Lopez Bernaldo de Quiros, J, Losa Garcia, J, Masia, M, Montero-Alsonso, M, Ocampo Hermida, A, Pasquau Liano, J, Portilla Sogorb, J, Pulido Ortega, F, Rivera Roman, A, Santos Fernandez, J, Torres Perea, R, Troya Garcia, J, Viciana Fernandez, P, Calmy, A, Hauser, C, Fehr, J, Cheng, S, Ko, W, Lin, H, Lu, P, Tseng, Y, Wang, N, Wong, W, Yang, C, Arduino, R, Benson, P, Berhe, M, Bredeek, F, Brinson, C, Campbell, T, Crofoot, G, Cunningham, D, Dejesus, E, Dretler, R, Eron, J, Fife, K, Fichtenbaum, C, Flamm, J, Goldstein, D, Gupta, S, Hagins, D, Hoffman-Terry, M, Jayaweera, D, Kinder, C, Klein, D, Mcdonald, C, Mills, A, Nahass, R, Osiyemi, O, Overton, E, Parks, D, Prelutsky, D, Ramgopal, M, Schrader, S, Sha, B, Simon, G, Sims, J, Skiest, D, Slim, J, Tashima, K, Thedinger, B, Gazzard, B, Fox, J, Johnson, M, Kegg, S, Khoo, S, Mazhude, C, Orkin, C, Schembri, G, Ustianowski, A, Cahn P., Madero J. S., Arribas J. R., Antinori A., Ortiz R., Clarke A. E., Hung C. -C., Rockstroh J. K., Girard P. -M., Sievers J., Man C., Currie A., Underwood M., Tenorio A. R., Pappa K., Wynne B., Fettiplace A., Gartland M., Aboud M., Smith K., Cassetti L., David D., Figueras L., Losso M., Lopardo G., Lupo S., Porteiro N., Sanchez M., Bloch M., Cooper D., Finlayson R., Kelleher A., Koh K., Lewis D., McMahon J., Moore R., Roth N., Shields M., De Wit S., Florence E., Goffard J. -C., Demeester R., Lacor P., Vandercam B., Vandekerckhove L., Angel J., Baril J. -G., Conway B., De Pokomandy A., Szabo J., Walmsley S., Bouchaud O., Chidiac C., Delobel P., Goujard C., Katlama C., Molina J. -M., Pialoux G., Philibert P., Bogner J., Esser S., Krznaric I., Lehmann C., Spinner C., Stellbrink H. -J., Stephan C., Stoehr A., Barchi E., Caramello P., Castelli F., Cattelan A. M., D'Arminio Monforte A., Di Biagio A., Di Perri G., Gori A., Maggiolo F., Menzaghi B., Migliorino G., Mussini C., Penco G., Puoti M., Rizzardini G., Gulminetti R., Lazzarin A., Quirino T., Sighinolfi L., Viale P., Amaya Tapia G., Andrade Villanueva J., Granados Reyes E. R., Perez Rios A., Santoscoy Gomez M., Den Hollander J., Rijnders B., Hidalgo J. A., Hercilla Vasquez L., Illescas L., Olczak A., Mansinho K., Correia Pacheco P. P., Teofilo E., Saraiva da Cunha J., Sarmento e Castro R., Serrao R., Arbune M., Jianu C., Oprea A., Preotescu L., Prisacariu L. -J., Belonosova E., Borodkina O., Chernova O., Gankina N., Kizhlo S., Kulagin V., Kurina N., Nagimova F., Pokrovsky V., Ryamova E., Voronin E., Yakovlev A., Kaplan R., Lee S. H., Kim S. -W., Kim S. -I., Kim W. J., Antela Lopez A., Casado Osorio J. L., Castano Carracedo M. A., De Los Santos Gil I., Estrada Perez V., Falco Ferrer V., Force L., Galinda Puerto M. J., Garcia Deltoro M., Gatell J. M., Goenaga Sanchez M. A., Gonzalez Cordon A., Knobel H., Lopez Bernaldo de Quiros J. C., Losa Garcia J. E., Masia M., Montero-Alsonso M., Ocampo Hermida A., Pasquau Liano J., Portilla Sogorb J., Pulido Ortega F., Rivera Roman A., Santos Fernandez J. R., Torres Perea R., Troya Garcia J., Viciana Fernandez P., Calmy A., Hauser C., Fehr J., Cheng S. -H., Ko W. -C., Lin H. -H., Lu P. -L., Tseng Y. -T., Wang N. -C., Wong W. -W., Yang C. -J., Arduino R., Benson P., Berhe M., Bredeek F., Brinson C., Campbell T., Crofoot G., Cunningham D., DeJesus E., Dretler R., Eron J., Fife K., Fichtenbaum C., Flamm J., Goldstein D., Gupta S., Hagins D., Hoffman-Terry M., Jayaweera D., Kinder C., Klein D., McDonald C., Mills A., Nahass R., Osiyemi O., Overton E., Parks D., Prelutsky D., Ramgopal M., Schrader S., Sha B., Simon G., Sims J., Skiest D., Slim J., Tashima K., Thedinger B., Gazzard B., Fox J., Johnson M., Kegg S., Khoo S., Mazhude C., Orkin C., Schembri G., Ustianowski A., Cahn, P, Madero, J, Arribas, J, Antinori, A, Ortiz, R, Clarke, A, Hung, C, Rockstroh, J, Girard, P, Sievers, J, Man, C, Currie, A, Underwood, M, Tenorio, A, Pappa, K, Wynne, B, Fettiplace, A, Gartland, M, Aboud, M, Smith, K, Cassetti, L, David, D, Figueras, L, Losso, M, Lopardo, G, Lupo, S, Porteiro, N, Sanchez, M, Bloch, M, Cooper, D, Finlayson, R, Kelleher, A, Koh, K, Lewis, D, Mcmahon, J, Moore, R, Roth, N, Shields, M, De Wit, S, Florence, E, Goffard, J, Demeester, R, Lacor, P, Vandercam, B, Vandekerckhove, L, Angel, J, Baril, J, Conway, B, De Pokomandy, A, Szabo, J, Walmsley, S, Bouchaud, O, Chidiac, C, Delobel, P, Goujard, C, Katlama, C, Molina, J, Pialoux, G, Philibert, P, Bogner, J, Esser, S, Krznaric, I, Lehmann, C, Spinner, C, Stellbrink, H, Stephan, C, Stoehr, A, Barchi, E, Caramello, P, Castelli, F, Cattelan, A, D'Arminio Monforte, A, Di Biagio, A, Di Perri, G, Gori, A, Maggiolo, F, Menzaghi, B, Migliorino, G, Mussini, C, Penco, G, Puoti, M, Rizzardini, G, Gulminetti, R, Lazzarin, A, Quirino, T, Sighinolfi, L, Viale, P, Amaya Tapia, G, Andrade Villanueva, J, Granados Reyes, E, Perez Rios, A, Santoscoy Gomez, M, Den Hollander, J, Rijnders, B, Hidalgo, J, Hercilla Vasquez, L, Illescas, L, Olczak, A, Mansinho, K, Correia Pacheco, P, Teofilo, E, Saraiva da Cunha, J, Sarmento e Castro, R, Serrao, R, Arbune, M, Jianu, C, Oprea, A, Preotescu, L, Prisacariu, L, Belonosova, E, Borodkina, O, Chernova, O, Gankina, N, Kizhlo, S, Kulagin, V, Kurina, N, Nagimova, F, Pokrovsky, V, Ryamova, E, Voronin, E, Yakovlev, A, Kaplan, R, Lee, S, Kim, S, Kim, W, Antela Lopez, A, Casado Osorio, J, Castano Carracedo, M, De Los Santos Gil, I, Estrada Perez, V, Falco Ferrer, V, Force, L, Galinda Puerto, M, Garcia Deltoro, M, Gatell, J, Goenaga Sanchez, M, Gonzalez Cordon, A, Knobel, H, Lopez Bernaldo de Quiros, J, Losa Garcia, J, Masia, M, Montero-Alsonso, M, Ocampo Hermida, A, Pasquau Liano, J, Portilla Sogorb, J, Pulido Ortega, F, Rivera Roman, A, Santos Fernandez, J, Torres Perea, R, Troya Garcia, J, Viciana Fernandez, P, Calmy, A, Hauser, C, Fehr, J, Cheng, S, Ko, W, Lin, H, Lu, P, Tseng, Y, Wang, N, Wong, W, Yang, C, Arduino, R, Benson, P, Berhe, M, Bredeek, F, Brinson, C, Campbell, T, Crofoot, G, Cunningham, D, Dejesus, E, Dretler, R, Eron, J, Fife, K, Fichtenbaum, C, Flamm, J, Goldstein, D, Gupta, S, Hagins, D, Hoffman-Terry, M, Jayaweera, D, Kinder, C, Klein, D, Mcdonald, C, Mills, A, Nahass, R, Osiyemi, O, Overton, E, Parks, D, Prelutsky, D, Ramgopal, M, Schrader, S, Sha, B, Simon, G, Sims, J, Skiest, D, Slim, J, Tashima, K, Thedinger, B, Gazzard, B, Fox, J, Johnson, M, Kegg, S, Khoo, S, Mazhude, C, Orkin, C, Schembri, G, Ustianowski, A, Cahn P., Madero J. S., Arribas J. R., Antinori A., Ortiz R., Clarke A. E., Hung C. -C., Rockstroh J. K., Girard P. -M., Sievers J., Man C., Currie A., Underwood M., Tenorio A. R., Pappa K., Wynne B., Fettiplace A., Gartland M., Aboud M., Smith K., Cassetti L., David D., Figueras L., Losso M., Lopardo G., Lupo S., Porteiro N., Sanchez M., Bloch M., Cooper D., Finlayson R., Kelleher A., Koh K., Lewis D., McMahon J., Moore R., Roth N., Shields M., De Wit S., Florence E., Goffard J. -C., Demeester R., Lacor P., Vandercam B., Vandekerckhove L., Angel J., Baril J. -G., Conway B., De Pokomandy A., Szabo J., Walmsley S., Bouchaud O., Chidiac C., Delobel P., Goujard C., Katlama C., Molina J. -M., Pialoux G., Philibert P., Bogner J., Esser S., Krznaric I., Lehmann C., Spinner C., Stellbrink H. -J., Stephan C., Stoehr A., Barchi E., Caramello P., Castelli F., Cattelan A. M., D'Arminio Monforte A., Di Biagio A., Di Perri G., Gori A., Maggiolo F., Menzaghi B., Migliorino G., Mussini C., Penco G., Puoti M., Rizzardini G., Gulminetti R., Lazzarin A., Quirino T., Sighinolfi L., Viale P., Amaya Tapia G., Andrade Villanueva J., Granados Reyes E. R., Perez Rios A., Santoscoy Gomez M., Den Hollander J., Rijnders B., Hidalgo J. A., Hercilla Vasquez L., Illescas L., Olczak A., Mansinho K., Correia Pacheco P. P., Teofilo E., Saraiva da Cunha J., Sarmento e Castro R., Serrao R., Arbune M., Jianu C., Oprea A., Preotescu L., Prisacariu L. -J., Belonosova E., Borodkina O., Chernova O., Gankina N., Kizhlo S., Kulagin V., Kurina N., Nagimova F., Pokrovsky V., Ryamova E., Voronin E., Yakovlev A., Kaplan R., Lee S. H., Kim S. -W., Kim S. -I., Kim W. J., Antela Lopez A., Casado Osorio J. L., Castano Carracedo M. A., De Los Santos Gil I., Estrada Perez V., Falco Ferrer V., Force L., Galinda Puerto M. J., Garcia Deltoro M., Gatell J. M., Goenaga Sanchez M. A., Gonzalez Cordon A., Knobel H., Lopez Bernaldo de Quiros J. C., Losa Garcia J. E., Masia M., Montero-Alsonso M., Ocampo Hermida A., Pasquau Liano J., Portilla Sogorb J., Pulido Ortega F., Rivera Roman A., Santos Fernandez J. R., Torres Perea R., Troya Garcia J., Viciana Fernandez P., Calmy A., Hauser C., Fehr J., Cheng S. -H., Ko W. -C., Lin H. -H., Lu P. -L., Tseng Y. -T., Wang N. -C., Wong W. -W., Yang C. -J., Arduino R., Benson P., Berhe M., Bredeek F., Brinson C., Campbell T., Crofoot G., Cunningham D., DeJesus E., Dretler R., Eron J., Fife K., Fichtenbaum C., Flamm J., Goldstein D., Gupta S., Hagins D., Hoffman-Terry M., Jayaweera D., Kinder C., Klein D., McDonald C., Mills A., Nahass R., Osiyemi O., Overton E., Parks D., Prelutsky D., Ramgopal M., Schrader S., Sha B., Simon G., Sims J., Skiest D., Slim J., Tashima K., Thedinger B., Gazzard B., Fox J., Johnson M., Kegg S., Khoo S., Mazhude C., Orkin C., Schembri G., and Ustianowski A.
- Abstract
Background: Effective two-drug regimens could decrease long-term drug exposure and toxicity with HIV-1 antiretroviral therapy (ART). We therefore aimed to evaluate the efficacy and safety of a two-drug regimen compared with a three-drug regimen for the treatment of HIV-1 infection in ART-naive adults. Methods: We conducted two identically designed, multicentre, double-blind, randomised, non-inferiority, phase 3 trials: GEMINI-1 and GEMINI-2. Both studies were done at 192 centres in 21 countries. We included participants (≥18 years) with HIV-1 infection and a screening HIV-1 RNA of 500 000 copies per mL or less, and who were naive to ART. We randomly assigned participants (1:1) to receive a once-daily two-drug regimen of dolutegravir (50 mg) plus lamivudine (300 mg) or a once-daily three-drug regimen of dolutegravir (50 mg) plus tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Both drug regimens were administered orally. We masked participants and investigators to treatment assignment: dolutegravir was administered as single-entity tablets (similar to its commercial formulation, except with a different film colour), and lamivudine tablets and tenofovir disoproxil fumarate and emtricitabine tablets were over-encapsulated to visually match each other. Primary endpoint was the proportion of participants with HIV-1 RNA of less than 50 copies per mL at week 48 in the intention-to-treat-exposed population, using the Snapshot algorithm and a non-inferiority margin of −10%. Safety analyses were done on the safety population. GEMINI-1 and GEMINI-2 are registered with ClinicalTrials.gov, numbers NCT02831673 and NCT02831764, respectively. Findings: Between July 18, 2016, and March 31, 2017, 1441 participants across both studies were randomly assigned to receive either the two-drug regimen (n=719) or three-drug regimen (n=722). At week 48 in the GEMINI-1 intention-to-treat-exposed population, 320 (90%) of 356 participants receiving the two-drug regimen and 332
- Published
- 2019
3. Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials
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Lathouwers E, Wong E, Brown K, Baugh B, Ghys A, Jezorwski J, Mohsine E, Van Landuyt E, Opsomer M, De Meyer S, De Wit S, Florence E, Vandekerckhove L, Vandercam B, Brunetta J, Klein M, Murphy D, Rachlis A, Walmsley S, Ajana F, Cotte L, Girard P, Katlama C, Molina J, Poizot-Martin I, Raffi F, Rey D, Reynes J, Teicher E, Yazdanpanah Y, Arasteh K, Bickel M, Bogner J, Esser S, Faetkenheuer G, Jessen H, Kern W, Rockstroh J, Spinner C, Stellbrink H, Stoehr A, Antinori A, Castelli F, Chirianni A, De Luca A, Di Biagio A, Galli M, Lazzarin A, Maggiolo F, Maserati R, Mussini C, Garlicki A, Gasiorowski J, Halota W, Horban A, Parczewski M, Piekarska A, Belonosova E, Chernova O, Dushkina N, Kulagin V, Ryamova E, Shuldyakov A, Sizova N, Tsybakova O, Voronin E, Yakovlev A, Antela A, Arribas J, Berenguer J, Casado J, Estrada V, Galindo M, Del Toro M, Gatell J, Gorgolas M, Gutierrez F, Gutierrez M, Negredo E, Pineda J, Podzamczer D, Sogorb J, Rivero A, Rubio R, Viciana P, De Los Santos I, Clarke A, Gazzard B, Johnson M, Orkin C, Reeves I, Waters L, Benson P, Bhatti L, Bredeek F, Crofoot G, Cunningham D, DeJesus E, Eron J, Felizarta F, Franco R, Gallant J, Hagins D, Henry K, Jayaweera D, Lucasti C, Martorell C, McDonald C, McGowan J, Mills A, Morales-Ramirez J, Prelutsky D, Ramgopal M, Rashbaum B, Ruane P, Slim J, Wilkin A, deVente J, Moutschen M, Van Wijngaerden E, Vekerckhove L, Vercam B, Conway B, Shafran S, AMBER Study Grp, and EMERALD Study Grp
- Subjects
resistance ,deep sequencing ,TAF ,efficacy ,virus diseases ,darunavir ,cobicistat ,archived RAMs ,emtricitabine ,single-tablet regimen - Abstract
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is being investigated in two Phase III trials, AMBER (NCT02431247; treatment-naive adults) and EMERALD (NCT02269917; treatment-experienced, virologically suppressed adults). Week 48 AMBER and EMERALD resistance analyses are presented. Postbaseline samples for genotyping/phenotyping were analyzed from protocol-defined virologic failures (PDVFs) with viral load (VL) >= 400 copies/mL at failure/later time points. Post hoc analyses were deep sequencing in AMBER, and HIV-1 proviral DNA from baseline samples (VL = 3 thymidine analog-associated mutations (24% not fully susceptible to tenofovir) detected at screening. All achieved VL
- Published
- 2020
4. Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials
- Author
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Lathouwers, Erkki, Wong, Eric Y, Brown, Kimberley, Baugh, Bryan, Ghys, Anne, Jezorwski, John, Mohsine, El Ghazi, Van Landuyt, Erika, Opsomer, Magda, De Meyer, Sandra, De Wit, S, Florence, E, Vandekerckhove, L, Vandercam, B, Brunetta, J, Klein, M, Murphy, D, Rachlis, A, Walmsley, S, Ajana, F, Cotte, L, Girard, P-M, Katlama, C, Molina, J-M, Poizot-Martin, I, Raffi, F, Rey, D, Reynes, J, Teicher, E, Yazdanpanah, Y, Arasteh, K, Bickel, M, Bogner, J, Esser, S, Faetkenheuer, G, Jessen, H, Kern, W, Rockstroh, J, Spinner, C, Stellbrink, H-J, Stoehr, A, Antinori, A, Castelli, F, Chirianni, A, De Luca, A, Di Biagio, A, Galli, M, Lazzarin, A, Maggiolo, F, Maserati, R, Mussini, C, Garlicki, A, Gasiorowski, J, Halota, W, Horban, A, Parczewski, M, Piekarska, A, Belonosova, E, Chernova, O, Dushkina, N, Kulagin, V, Ryamova, E, Shuldyakov, A, Sizova, N, Tsybakova, O, Voronin, E, Yakovlev, A, Antela, A, Arribas, JR, Berenguer, J, Casado, J, Estrada, V, Galindo, MJ, Garcia Del Toro, M, Gatell, JM, Gorgolas, M, Gutierrez, F, Gutierrez, MDM, Negredo, E, Pineda, JA, Podzamczer, D, Portilla Sogorb, J, Rivero, A, Rubio, R, Viciana, P, De Los Santos, I, Clarke, A, Gazzard, BG, Johnson, MA, Orkin, C, Reeves, I, Waters, L, Benson, P, Bhatti, L, Bredeek, F, Crofoot, G, Cunningham, D, DeJesus, E, Eron, J, Felizarta, F, Franco, R, Gallant, J, Hagins, D, Henry, K, Jayaweera, D, Lucasti, C, Martorell, C, McDonald, C, McGowan, J, Mills, A, Morales-Ramirez, J, Prelutsky, D, Ramgopal, M, Rashbaum, B, Ruane, P, Slim, J, Wilkin, A, deVente, J, Moutschen, M, Van Wijngaerden, E, Vekerckhove, L, Vercam, B, Conway, B, Shafran, S, Janssen Pharmaceutica [Beerse], Janssen Pharmaceutical Research and Development Titusville, AMBER and EMERALD Study Groups: S De Wit, E Florence, L Vandekerckhove, B Vandercam, J Brunetta, M Klein, D Murphy, A Rachlis, S Walmsley, F Ajana, L Cotte, P-M Girard, C Katlama, J-M Molina, I Poizot-Martin, F Raffi, D Rey, J Reynes, E Teicher, Y Yazdanpanah, K Arastéh, M Bickel, J Bogner, S Esser, G Faetkenheuer, H Jessen, W Kern, J Rockstroh, C Spinner, H-J Stellbrink, A Stoehr, A Antinori, F Castelli, A Chirianni, A De Luca, A Di Biagio, M Galli, A Lazzarin, F Maggiolo, R Maserati, C Mussini, A Garlicki, J Gasiorowski, W Halota, A Horban, M Parczewski, A Piekarska, E Belonosova, O Chernova, N Dushkina, V Kulagin, E Ryamova, A Shuldyakov, N Sizova, O Tsybakova, E Voronin, A Yakovlev, A Antela, J R Arribas, J Berenguer, J Casado, V Estrada, M J Galindo, M Garcia Del Toro, J M Gatell, M Gorgolas, F Gutierrez, Mdm Gutierrez, E Negredo, J A Pineda, D Podzamczer, J Portilla Sogorb, A Rivero, R Rubio, P Viciana, I De Los Santos, A Clarke, B G Gazzard, M A Johnson, C Orkin, I Reeves, L Waters, P Benson, L Bhatti, F Bredeek, G Crofoot, D Cunningham, E DeJesus, J Eron, F Felizarta, R Franco, J Gallant, D Hagins, K Henry, D Jayaweera, C Lucasti, C Martorell, C McDonald, J McGowan, A Mills, J Morales-Ramirez, D Prelutsky, M Ramgopal, B Rashbaum, P Ruane, J Slim, A Wilkin, J deVente, S De Wit, E Florence, M Moutschen, E Van Wijngaerden, L Vandekerckhove, B Vandercam, J Brunetta, B Conway, M Klein, D Murphy, A Rachlis, S Shafran, S Walmsley, F Ajana, L Cotte, P-M Girard, C Katlama, J-M Molina, I Poizot-Martin, F Raffi, D Rey, J Reynes, E Teicher, Y Yazdanpanah, J Gasiorowski, W Halota, A Horban, A Piekarska, A Witor, J R Arribas, I Perez-Valero, J Berenguer, J Casado, J M Gatell, F Gutierrez, M J Galindo, Mdm Gutierrez, J A Iribarren, H Knobel, E Negredo, J A Pineda, D Podzamczer, J Portilla Sogorb, F Pulido, C Ricart, A Rivero, I Santos Gil, A Blaxhult, L Flamholc, M Gisslèn, A Thalme, J Fehr, A Rauch, M Stoeckle, A Clarke, B G Gazzard, M A Johnson, C Orkin, F Post, A Ustianowski, L Waters, J Bailey, P Benson, L Bhatti, I Brar, U F Bredeek, C Brinson, G Crofoot, D Cunningham, E DeJesus, C Dietz, R Dretler, J Eron, F Felizarta, C Fichtenbaum, J Gallant, J Gathe, D Hagins, S Henn, K W Henry, G Huhn, M Jain, C Lucasti, C Martorell, C McDonald, A Mills, J Morales-Ramirez, K Mounzer, R Nahass, H Olivet, O Osiyemi, D Prelutsky, M Ramgopal, B Rashbaum, G Richmond, P Ruane, A Scarsella, A Scribner, P Shalit, D Shamblaw, J Slim, K Tashima, G Voskuhl, D Ward, A Wilkin, J de Vente, and Malbec, Odile
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0301 basic medicine ,[SDV]Life Sciences [q-bio] ,efficacy ,Human immunodeficiency virus (HIV) ,HIV Infections ,darunavir ,medicine.disease_cause ,VIRALLY SUPPRESSED ADULTS ,PLUS LAMIVUDINE ,DOUBLE-BLIND ,0302 clinical medicine ,INFECTION ,Medicine and Health Sciences ,Emtricitabine ,030212 general & internal medicine ,Darunavir ,Emtricitabine tenofovir alafenamide ,Alanine ,Cobicistat ,Single tablet regimen ,virus diseases ,Viral Load ,OPEN-LABEL ,3. Good health ,[SDV] Life Sciences [q-bio] ,Drug Combinations ,Infectious Diseases ,NON-INFERIORITY ,INITIAL TREATMENT ,Reverse Transcriptase Inhibitors ,Life Sciences & Biomedicine ,Tablets ,medicine.drug ,Adult ,TENOFOVIR DISOPROXIL FUMARATE ,Anti-HIV Agents ,Darunavir/Cobicistat ,Immunology ,archived RAMs ,Tenofovir alafenamide ,Drug Administration Schedule ,single-tablet regimen ,resistance ,03 medical and health sciences ,deep sequencing ,Virology ,Drug Resistance, Viral ,medicine ,darunavir/cobicistat/emtricitabine/TAF ,Humans ,Clinical Trials/Clinical Studies ,Tenofovir ,emtricitabine ,DRUG-RESISTANCE ,Science & Technology ,TREATMENT-NAIVE PATIENTS ,business.industry ,Adenine ,cobicistat ,030104 developmental biology ,TAF ,HIV-1 ,business - Abstract
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is being investigated in two Phase III trials, AMBER (NCT02431247; treatment-naive adults) and EMERALD (NCT02269917; treatment-experienced, virologically suppressed adults). Week 48 AMBER and EMERALD resistance analyses are presented. Postbaseline samples for genotyping/phenotyping were analyzed from protocol-defined virologic failures (PDVFs) with viral load (VL) ≥400 copies/mL at failure/later time points. Post hoc analyses were deep sequencing in AMBER, and HIV-1 proviral DNA from baseline samples (VL
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- 2019
5. Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-experienced, virologically-suppressed adults living with HIV-1
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Eron, Joseph J., primary, Orkin, Chloe, additional, Cunningham, Douglas, additional, Pulido, Federico, additional, Post, Frank A., additional, De Wit, Stéphane, additional, Lathouwers, Erkki, additional, Hufkens, Veerle, additional, Jezorwski, John, additional, Petrovic, Romana, additional, Brown, Kimberley, additional, Van Landuyt, Erika, additional, Opsomer, Magda, additional, De Wit, S., additional, Florence, E., additional, Moutschen, M., additional, Van Wijngaerden, E., additional, Vandekerckhove, L., additional, Vandercam, B., additional, Brunetta, J., additional, Conway, B., additional, Klein, M., additional, Murphy, D., additional, Rachlis, A., additional, Shafran, S., additional, Walmsley, S., additional, Ajana, F., additional, Cotte, L., additional, Girardy, P.-M., additional, Katlama, C., additional, Molina, J.-M., additional, Poizot-Martin, I., additional, Raffi, F., additional, Rey, D., additional, Reynes, J., additional, Teicher, E., additional, Yazdanpanah, Y., additional, Gasiorowski, J., additional, Halota, W., additional, Horban, A., additional, Piekarska, A., additional, Witor, A., additional, Arribas, J.R., additional, Perez-Valero, I., additional, Berenguer, J., additional, Casado, J., additional, Gatell, J.M., additional, Gutierrez, F., additional, Galindo, M.J., additional, Gutierrez, M.D.M., additional, Iribarren, J.A., additional, Knobel, H., additional, Negredo, E., additional, Pineda, J.A., additional, Podzamczer, D., additional, Sogorb, J.Portilla, additional, Pulido, F., additional, Ricart, C., additional, Rivero, A., additional, Santos Gil, I., additional, Blaxhult, A., additional, Flamholc, L., additional, Gisslèn, M., additional, Thalme, A., additional, Fehr, J., additional, Rauch, A., additional, Stoeckle, M., additional, Clarke, A., additional, Gazzard, B.G., additional, Johnson, M.A., additional, Orkin, C., additional, Post, F., additional, Ustianowski, A., additional, Waters, L., additional, Bailey, J., additional, Benson, P., additional, Bhatti, L., additional, Brar, I., additional, Bredeek, U.F., additional, Brinson, C., additional, Crofoot, G., additional, Cunningham, D., additional, DeJesus, E., additional, Dietz, C., additional, Dretler, R., additional, Eron, J., additional, Felizarta, F., additional, Fichtenbaum, C., additional, Gallant, J., additional, Gathe, J., additional, Hagins, D., additional, Henn, S., additional, Henry, W.K., additional, Huhn, G., additional, Jain, M., additional, Lucasti, C., additional, Martorell, C., additional, McDonald, C., additional, Mills, A., additional, Morales-Ramirez, J., additional, Mounzer, K., additional, Nahass, R., additional, Olivet, H., additional, Osiyemi, O., additional, Prelutsky, D., additional, Ramgopal, M., additional, Rashbaum, B., additional, Richmond, G., additional, Ruane, P., additional, Scarsella, A., additional, Scribner, A., additional, Shalit, P., additional, Shamblaw, D., additional, Slim, J., additional, Tashima, K., additional, Voskuhl, G., additional, Ward, D., additional, Wilkin, A., additional, and de Vente, J., additional
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- 2019
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6. Giant esophageal aphthous ulcers in AIDS patients: treatment with low-dose corticosteroids
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Sokol-Anderson, M L, Prelutsky, D J, and Westblom, T U
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- 1991
7. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial
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Orkin, Chloe, primary, Molina, Jean-Michel, additional, Negredo, Eugenia, additional, Arribas, José R, additional, Gathe, Joseph, additional, Eron, Joseph J, additional, Van Landuyt, Erika, additional, Lathouwers, Erkki, additional, Hufkens, Veerle, additional, Petrovic, Romana, additional, Vanveggel, Simon, additional, Opsomer, Magda, additional, Ajana, F, additional, Arribas, JR, additional, Bailey, J, additional, Benson, P, additional, Berenguer, J, additional, Bhatti, L, additional, Blaxhult, A, additional, Brar, I, additional, Bredeek, UF, additional, Brinson, C, additional, Brunetta, J, additional, Casado, J, additional, Clarke, A, additional, Conway, B, additional, Cotte, L, additional, Crofoot, G, additional, Cunningham, D, additional, de Vente, J, additional, De Wit, S, additional, DeJesus, E, additional, Dietz, C, additional, Dretler, R, additional, Eron, J, additional, Fehr, J, additional, Felizarta, F, additional, Fichtenbaum, C, additional, Flamholc, L, additional, Florence, E, additional, Galindo, MJ, additional, Gallant, J, additional, Gasiorowski, J, additional, Gatell, JM, additional, Gathe, J, additional, Gazzard, BG, additional, Girard, P-M, additional, Gisslèn, M, additional, Gutierrez, F, additional, Gutierrez, MDM, additional, Hagins, D, additional, Halota, W, additional, Henn, S, additional, Henry, WK, additional, Horban, A, additional, Huhn, G, additional, Iribarren, JA, additional, Jain, M, additional, Johnson, MA, additional, Katlama, C, additional, Klein, M, additional, Knobel, H, additional, Lucasti, C, additional, Martorell, C, additional, McDonald, C, additional, Mills, A, additional, Molina, J-M, additional, Morales-Ramirez, J, additional, Mounzer, K, additional, Moutschen, M, additional, Murphy, D, additional, Nahass, R, additional, Negredo, E, additional, Olivet, H, additional, Orkin, C, additional, Osiyemi, O, additional, Perez-Valero, I, additional, Piekarska, A, additional, Pineda, JA, additional, Podzamczer, D, additional, Poizot-Martin, I, additional, Portilla Sogorb, J, additional, Post, F, additional, Prelutsky, D, additional, Pulido, F, additional, Rachlis, A, additional, Raffi, F, additional, Ramgopal, M, additional, Rashbaum, B, additional, Rauch, A, additional, Rey, D, additional, Reynes, J, additional, Ricart, C, additional, Richmond, G, additional, Rivero, A, additional, Ruane, P, additional, Gil, I Santos, additional, Scarsella, A, additional, Scribner, A, additional, Shafran, S, additional, Shalit, P, additional, Shamblaw, D, additional, Slim, J, additional, Stoeckle, M, additional, Tashima, K, additional, Teicher, E, additional, Thalme, A, additional, Ustianowski, A, additional, Van Wijngaerden, E, additional, Vandekerckhove, L, additional, Vandercam, B, additional, Voskuhl, G, additional, Walmsley, S, additional, Ward, D, additional, Waters, L, additional, Wilkin, A, additional, Witor, A, additional, and Yazdanpanah, Y, additional
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- 2018
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8. Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-experienced, virologically-suppressed adults living with HIV-1
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Bailey, J., Ajana, F., Arribas, J.R., Brunetta, J., Halota, W., Raffi, F., Brinson, C., Eron, J., Post, F., Ward, D., Katlama, C., Pineda, J.A., Rauch, A., Vandercam, B., Molina, J.-M., Slim, J., Crofoot, G., Prelutsky, D., Shamblaw, D., Van Wijngaerden, E., Opsomer, M., Pulido, F., Brown, K., Henn, S., Santos Gil, I., Perez-Valero, I., Flamholc, L., Ruane, P., Ricart, C., De Wit, S., Rey, D., Post, F.A., Murphy, D., Negredo, E., Gatell, J.M., Gathe, J., DeJesus, E., Iribarren, J.A., Rashbaum, B., Fehr, J., Dretler, R., Brar, I., Hagins, D., Voskuhl, G., Jain, M., Henry, W.K., Gasiorowski, J., Mills, A., Rivero, A., Van Landuyt, E., Gutierrez, F., Petrovic, R., Gazzard, B.G., Piekarska, A., Walmsley, S., de Vente, J., Girardy, P.-M., Shafran, S., Rachlis, A., Bhatti, L., Knobel, H., Sogorb, J.P., Cunningham, D., Mounzer, K., Klein, M., Galindo, M.J., Clarke, A., Stoeckle, M., Fichtenbaum, C., Dietz, C., EMERALD study group, Olivet, H., Poizot-Martin, I., Nahass, R., Richmond, G., Eron, J.J., Wilkin, A., Benson, P., Morales-Ramirez, J., Lathouwers, E., Lucasti, C., Moutschen, M., Osiyemi, O., Casado, J., Gallant, J., Jezorwski, J., Teicher, E., Cotte, L., Vandekerckhove, L., Podzamczer, D., Gisslen, M., Gutierrez, M.D.M., Bredeek, U.F., Waters, L., Scribner, A., Orkin, C., Conway, B., Yazdanpanah, Y., Felizarta, F., Reynes, J., Johnson, M.A., Ustianowski, A., Thalme, A., Martorell, C., McDonald, C., Tashima, K., Berenguer, J., Florence, E., Huhn, G., Shalit, P., Ramgopal, M., Witor, A., Blaxhult, A., Scarsella, A., Horban, A., and Hufkens, V.
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3. Good health - Abstract
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in EMERALD (NCT02269917). Virologically-suppressed, HIV-1-positive treatment-experienced adults (previous non-darunavir virologic failure [VF] allowed) were randomized (2:1) to D/C/F/TAF or boosted protease inhibitor (PI) plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) over 48 weeks. At week 52 participants in the boosted PI arm were offered switch to D/C/F/TAF (late-switch, 44 weeks D/C/F/TAF exposure). All participants were followed on D/C/F/TAF until week 96. Efficacy endpoints were percentage cumulative protocol-defined virologic rebound (PDVR; confirmed viral load [VL] ≥50 copies/mL) and VL < 50 copies/mL (virologic suppression) and ≥50 copies/mL (VF) (FDA-snapshot analysis). Of 1141 randomized patients, 1080 continued in the extension phase. Few patients had PDVR (D/C/F/TAF: 3.1%, 24/763 cumulative through week 96; late-switch: 2.3%, 8/352 week 52–96). Week 96 virologic suppression was 90.7% (692/763) (D/C/F/TAF) and 93.8% (330/352) (late-switch). VF was 1.2% and 1.7%, respectively. No darunavir, primary PI, tenofovir or emtricitabine resistance-associated mutations were observed post-baseline. No patients discontinued for efficacy-related reasons. Few discontinued due to adverse events (2% D/C/F/TAF arm). Improved renal and bone parameters were maintained in the D/C/F/TAF arm and observed in the late-switch arm, with small increases in total cholesterol/high-density-lipoprotein-cholesterol ratio. A study limitation was the lack of a control arm in the week 96 analysis. Through 96 weeks, D/C/F/TAF resulted in low PDVR rates, high virologic suppression rates, very few VFs, and no resistance development. Late-switch results were consistent with D/C/F/TAF week 48 results. EMERALD week 96 results confirm the efficacy, high genetic barrier to resistance and safety benefits of D/C/F/TAF.
9. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials
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Pedro Cahn, Juan Sierra Madero, José Ramón Arribas, Andrea Antinori, Roberto Ortiz, Amanda E Clarke, Chien-Ching Hung, Jürgen K Rockstroh, Pierre-Marie Girard, Jörg Sievers, Choy Man, Alexander Currie, Mark Underwood, Allan R Tenorio, Keith Pappa, Brian Wynne, Anna Fettiplace, Martin Gartland, Michael Aboud, Kimberly Smith, Lidia Cassetti, Daniel David, Laura Figueras, Marcelo Losso, Gustavo Lopardo, Sergio Lupo, Norma Porteiro, Marisa Sánchez, Mark Bloch, David Cooper, Robert Finlayson, Anthony Kelleher, Kenneth Koh, David Lewis, James McMahon, Richard Moore, Norman Roth, Matthew Shields, Stephane De Wit, Eric Florence, Jean-Christophe Goffard, Remy Demeester, Patrick Lacor, Bernard Vandercam, Linos Vandekerckhove, Jonathan Angel, Jean-Guy Baril, Brian Conway, Alexandra De Pokomandy, Jason Szabo, Sharon Walmsley, Olivier Bouchaud, Christian Chidiac, Pierre Delobel, Cecile Goujard, Christine Katlama, Jean-Michel Molina, Gilles Pialoux, Patrick Philibert, Johannes Bogner, Stefan Esser, Ivanka Krznaric, Clara Lehmann, Christoph Spinner, Hans-Jurgen Stellbrink, Christoph Stephan, Albrecht Stoehr, Enrico Barchi, Pietro Caramello, Francesco Castelli, Anna Maria Cattelan, Antonella D'Arminio Monforte, Antonio Di Biagio, Giovanni Di Perri, Andrea Gori, Franco Maggiolo, Barbara Menzaghi, Guglielmo Migliorino, Cristina Mussini, Giovanni Penco, Massimo Puoti, Giuliano Rizzardini, Roberto Gulminetti, Adriano Lazzarin, Tiziano Quirino, Laura Sighinolfi, Pierluigi Viale, Gerardo Amaya Tapia, Jaime Andrade Villanueva, Enrique R Granados Reyes, Alma Perez Rios, Mario Santoscoy Gomez, Jan Den Hollander, Bart Rijnders, José A Hidalgo, Luis Hercilla Vasquez, Luis Illescas, Anita Olczak, Kamal Mansinho, Patricia Paula Correia Pacheco, Eugénio Teófilo, Jose Saraiva da Cunha, Rui Sarmento e Castro, Rosário Serrão, Manuela Arbune, Cristian Jianu, Anca Oprea, Liliana Preotescu, Liviu-Jany Prisacariu, Elena Belonosova, Olga Borodkina, Oxana Chernova, Natalia Gankina, Svetlana Kizhlo, Valeriy Kulagin, Nadezhda Kurina, Firaya Nagimova, Vadim Pokrovsky, Elena Ryamova, Evgeny Voronin, Alexey Yakovlev, Richard Kaplan, Sun Hee Lee, Shin-Woo Kim, Sang-Il Kim, Woo Joo Kim, Antonio Antela Lopez, Jose L Casado Osorio, Manuel A Castaño Carracedo, Ignacio De Los Santos Gil, Vicente Estrada Perez, Vicenç Falco Ferrer, Luis Force, Maria Jose Galinda Puerto, Miguel Garcia Deltoro, Josep M Gatell, Miguel A Goenaga Sanchez, Ana González Cordón, Hernando Knobel, Juan Carlos Lopez Bernaldo de Quiros, Juan E Losa Garcia, Mar Masia, Marta Montero-Alsonso, Antonio Ocampo Hermida, Juan Pasquau Liaño, Joaquin Portilla Sogorb, Federico Pulido Ortega, Antonio Rivera Roman, Jose Ramon Santos Fernandez, Rafael Torres Perea, Jesus Troya Garcia, Pompeyo Viciana Fernandez, Alexandra Calmy, Christoph Hauser, Jan Fehr, Shu-Hsing Cheng, Wen-Chien Ko, Hsi-Hsun Lin, Po-Liang Lu, Yu-Ting Tseng, Ning-Chi Wang, Wing-Wai Wong, Chia-Jui Yang, Roberto Arduino, Paul Benson, Mezgebe Berhe, Fritz Bredeek, Cynthia Brinson, Thomas Campbell, Gordon Crofoot, Douglas Cunningham, Edwin DeJesus, Robin Dretler, Joseph Eron, Kenneth Fife, Carl Fichtenbaum, Jason Flamm, Deborah Goldstein, Samir Gupta, Debbie Hagins, Margaret Hoffman-Terry, Dushyantha Jayaweera, Clifford Kinder, Daniel Klein, Cheryl McDonald, Anthony Mills, Ronald Nahass, Olayemi Osiyemi, Edgar Overton, David Parks, David Prelutsky, Moti Ramgopal, Shannon Schrader, Beverly Sha, Gary Simon, James Sims, Daniel Skiest, Jihad Slim, Karen Tashima, Blair Thedinger, Brian Gazzard, Julie Fox, Margaret Johnson, Stephen Kegg, Saye Khoo, Charles Mazhude, Chloe Orkin, Gabriel Schembri, Andrew Ustianowski, Clinical sciences, Microbiology and Infection Control, Internal Medicine, Cahn, P, Madero, J, Arribas, J, Antinori, A, Ortiz, R, Clarke, A, Hung, C, Rockstroh, J, Girard, P, Sievers, J, Man, C, Currie, A, Underwood, M, Tenorio, A, Pappa, K, Wynne, B, Fettiplace, A, Gartland, M, Aboud, M, Smith, K, Cassetti, L, David, D, Figueras, L, Losso, M, Lopardo, G, Lupo, S, Porteiro, N, Sanchez, M, Bloch, M, Cooper, D, Finlayson, R, Kelleher, A, Koh, K, Lewis, D, Mcmahon, J, Moore, R, Roth, N, Shields, M, De Wit, S, Florence, E, Goffard, J, Demeester, R, Lacor, P, Vandercam, B, Vandekerckhove, L, Angel, J, Baril, J, Conway, B, De Pokomandy, A, Szabo, J, Walmsley, S, Bouchaud, O, Chidiac, C, Delobel, P, Goujard, C, Katlama, C, Molina, J, Pialoux, G, Philibert, P, Bogner, J, Esser, S, Krznaric, I, Lehmann, C, Spinner, C, Stellbrink, H, Stephan, C, Stoehr, A, Barchi, E, Caramello, P, Castelli, F, Cattelan, A, D'Arminio Monforte, A, Di Biagio, A, Di Perri, G, Gori, A, Maggiolo, F, Menzaghi, B, Migliorino, G, Mussini, C, Penco, G, Puoti, M, Rizzardini, G, Gulminetti, R, Lazzarin, A, Quirino, T, Sighinolfi, L, Viale, P, Amaya Tapia, G, Andrade Villanueva, J, Granados Reyes, E, Perez Rios, A, Santoscoy Gomez, M, Den Hollander, J, Rijnders, B, Hidalgo, J, Hercilla Vasquez, L, Illescas, L, Olczak, A, Mansinho, K, Correia Pacheco, P, Teofilo, E, Saraiva da Cunha, J, Sarmento e Castro, R, Serrao, R, Arbune, M, Jianu, C, Oprea, A, Preotescu, L, Prisacariu, L, Belonosova, E, Borodkina, O, Chernova, O, Gankina, N, Kizhlo, S, Kulagin, V, Kurina, N, Nagimova, F, Pokrovsky, V, Ryamova, E, Voronin, E, Yakovlev, A, Kaplan, R, Lee, S, Kim, S, Kim, W, Antela Lopez, A, Casado Osorio, J, Castano Carracedo, M, De Los Santos Gil, I, Estrada Perez, V, Falco Ferrer, V, Force, L, Galinda Puerto, M, Garcia Deltoro, M, Gatell, J, Goenaga Sanchez, M, Gonzalez Cordon, A, Knobel, H, Lopez Bernaldo de Quiros, J, Losa Garcia, J, Masia, M, Montero-Alsonso, M, Ocampo Hermida, A, Pasquau Liano, J, Portilla Sogorb, J, Pulido Ortega, F, Rivera Roman, A, Santos Fernandez, J, Torres Perea, R, Troya Garcia, J, Viciana Fernandez, P, Calmy, A, Hauser, C, Fehr, J, Cheng, S, Ko, W, Lin, H, Lu, P, Tseng, Y, Wang, N, Wong, W, Yang, C, Arduino, R, Benson, P, Berhe, M, Bredeek, F, Brinson, C, Campbell, T, Crofoot, G, Cunningham, D, Dejesus, E, Dretler, R, Eron, J, Fife, K, Fichtenbaum, C, Flamm, J, Goldstein, D, Gupta, S, Hagins, D, Hoffman-Terry, M, Jayaweera, D, Kinder, C, Klein, D, Mcdonald, C, Mills, A, Nahass, R, Osiyemi, O, Overton, E, Parks, D, Prelutsky, D, Ramgopal, M, Schrader, S, Sha, B, Simon, G, Sims, J, Skiest, D, Slim, J, Tashima, K, Thedinger, B, Gazzard, B, Fox, J, Johnson, M, Kegg, S, Khoo, S, Mazhude, C, Orkin, C, Schembri, G, and Ustianowski, A
- Subjects
Male ,HIV Dolutegravir ,HIV Infections ,030204 cardiovascular system & hematology ,Piperazines ,chemistry.chemical_compound ,0302 clinical medicine ,Abacavir ,Heterocyclic Compounds ,Emtricitabine ,030212 general & internal medicine ,Viral ,Tenofovir/adverse effects ,Lamivudine/adverse effects ,Medicine(all) ,education.field_of_study ,Adult ,Anti-HIV Agents ,Anti-Retroviral Agents ,Double-Blind Method ,Drug Therapy, Combination ,Female ,HIV-1 ,Heterocyclic Compounds, 3-Ring ,Humans ,Lamivudine ,Middle Aged ,RNA, Viral ,Tenofovir ,Viral Load ,Heterocyclic Compounds, 3-Ring/adverse effects ,General Medicine ,Emtricitabine/adverse effects ,Tolerability ,Dolutegravir ,Combination ,medicine.drug ,medicine.medical_specialty ,Pyridones ,Population ,HIV Infections/drug therapy ,Anti-Retroviral Agents/adverse effects ,3-Ring ,03 medical and health sciences ,Drug Therapy ,SDG 3 - Good Health and Well-being ,Internal medicine ,Oxazines ,medicine ,HIV-1/isolation & purification ,RNA, Viral/blood ,education ,business.industry ,Viral Load/drug effects ,Regimen ,chemistry ,RNA ,Anti-HIV Agents/adverse effects ,Ritonavir ,business - Abstract
Summary Background Effective two-drug regimens could decrease long-term drug exposure and toxicity with HIV-1 antiretroviral therapy (ART). We therefore aimed to evaluate the efficacy and safety of a two-drug regimen compared with a three-drug regimen for the treatment of HIV-1 infection in ART-naive adults. Methods We conducted two identically designed, multicentre, double-blind, randomised, non-inferiority, phase 3 trials: GEMINI-1 and GEMINI-2. Both studies were done at 192 centres in 21 countries. We included participants (≥18 years) with HIV-1 infection and a screening HIV-1 RNA of 500 000 copies per mL or less, and who were naive to ART. We randomly assigned participants (1:1) to receive a once-daily two-drug regimen of dolutegravir (50 mg) plus lamivudine (300 mg) or a once-daily three-drug regimen of dolutegravir (50 mg) plus tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Both drug regimens were administered orally. We masked participants and investigators to treatment assignment: dolutegravir was administered as single-entity tablets (similar to its commercial formulation, except with a different film colour), and lamivudine tablets and tenofovir disoproxil fumarate and emtricitabine tablets were over-encapsulated to visually match each other. Primary endpoint was the proportion of participants with HIV-1 RNA of less than 50 copies per mL at week 48 in the intention-to-treat-exposed population, using the Snapshot algorithm and a non-inferiority margin of −10%. Safety analyses were done on the safety population. GEMINI-1 and GEMINI-2 are registered with ClinicalTrials.gov, numbers NCT02831673 and NCT02831764, respectively. Findings Between July 18, 2016, and March 31, 2017, 1441 participants across both studies were randomly assigned to receive either the two-drug regimen (n=719) or three-drug regimen (n=722). At week 48 in the GEMINI-1 intention-to-treat-exposed population, 320 (90%) of 356 participants receiving the two-drug regimen and 332 (93%) of 358 receiving the three-drug regimen achieved plasma HIV-1 RNA of less than 50 copies per mL (adjusted treatment difference −2·6%, 95% CI −6·7 to 1·5); in GEMINI-2, 335 (93%) of 360 in the two-drug regimen and 337 (94%) of 359 in the three-drug regimen achieved HIV-1 RNA of less than 50 copies per mL (adjusted treatment difference −0·7%, 95% CI −4·3 to 2·9), showing non-inferiority at a −10% margin in both studies (pooled analysis: 655 [91%] of 716 in the two-drug regimen vs 669 [93%] of 717 in the three-drug regimen; adjusted treatment difference −1·7%, 95% CI −4·4 to 1·1). Numerically, more drug-related adverse events occurred with the three-drug regimen than with the two-drug regimen (169 [24%] of 717 vs 126 [18%] of 716); few participants discontinued because of adverse events (16 [2%] in the three-drug regimen and 15 [2%] in the two-drug regimen). Two deaths were reported in the two-drug regimen group of GEMINI-2, but neither was considered to be related to the study medication. Interpretation The non-inferior efficacy and similar tolerability profile of dolutegravir plus lamivudine to a guideline-recommended three-drug regimen at 48 weeks in ART-naive adults supports its use as initial therapy for patients with HIV-1 infection. Funding ViiV Healthcare.
- Published
- 2019
10. Histoplasmoma: isolated central nervous system infection with Histoplasma capsulatum in a patient with AIDS. Case report and brief review of the literature.
- Author
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Azizirad O, Clifford DB, Groger RK, Prelutsky D, and Schmidt RE
- Subjects
- Adult, Brain Diseases pathology, Brain Diseases therapy, Combined Modality Therapy, Diagnosis, Differential, Disease Progression, Histoplasmosis pathology, Histoplasmosis therapy, Humans, Magnetic Resonance Imaging, Male, Positron-Emission Tomography, Tegmentum Mesencephali pathology, AIDS-Related Opportunistic Infections diagnosis, Brain Diseases diagnosis, Histoplasma, Histoplasmosis diagnosis
- Abstract
Histoplasma capsulatum is endemic to the Ohio and Mississippi River valleys. Exposure to H. capsulatum is very common in this region and usually follows a benign clinical course. However, immunocompromised hosts, like those with HIV/AIDS, are more susceptible to symptomatic infection, and have a greater chance of developing disseminated disease. We report an unusual case of a patient with AIDS presenting with a single ring-enhancing brain lesion and a focal neurological deficit. Workup was unrevealing, and brain biopsy was felt to represent too much risk as the lesion was located at the right tegmentum. The lesion enlarged over a period of months, and he underwent radiation therapy after the lesion caused obstructive hydrocephalus. He expired soon after completion of radiation therapy. At autopsy, the mass lesion was noted to contain organisms constant with H. capsulatum, pathologically consistent with a histoplasmoma.
- Published
- 2007
- Full Text
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