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Dolutegravir as First- or Second-Line Treatment for HIV-1 Infection in Children.
Turkova, Anna; White, Ellen; Mujuru, Hilda A; Kekitiinwa, Adeodata R; Kityo, Cissy M; Violari, Avy; Lugemwa, Abbas; Cressey, Tim R; Musoke, Philippa; Variava, Ebrahim; Cotton, Mark F; Archary, Moherndran; Puthanakit, Thanyawee; Behuhuma, Osee; Kobbe, Robin; Welch, Steven B; Bwakura-Dangarembizi, Mutsa; Amuge, Pauline; Kaudha, Elizabeth; Barlow-Mosha, Linda; Makumbi, Shafic; Ramsagar, Nastassja; Ngampiyaskul, Chaiwat; Musoro, Godfrey; Atwine, Lorna; Liberty, Afaaf; Musiime, Victor; Bbuye, Dickson; Ahimbisibwe, Grace M; Chalermpantmetagul, Suwalai; Ali, Shabinah; Sarfati, Tatiana; Wynne, Ben; Shakeshaft, Clare; Colbers, Angela; Klein, Nigel; Bernays, Sarah; Saïdi, Yacine; Coelho, Alexandra; Grossele, Tiziana; Compagnucci, Alexandra; Giaquinto, Carlo; Rojo, Pablo; Ford, Deborah; Gibb, Diana M.
Afiliación
  • Turkova A; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • White E; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Mujuru HA; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Kekitiinwa AR; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Kityo CM; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Violari A; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Lugemwa A; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Cressey TR; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Musoke P; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Variava E; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Cotton MF; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Archary M; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Puthanakit T; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Behuhuma O; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Kobbe R; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Welch SB; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Bwakura-Dangarembizi M; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Amuge P; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Kaudha E; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Barlow-Mosha L; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Makumbi S; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Ramsagar N; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Ngampiyaskul C; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Musoro G; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Atwine L; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Liberty A; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Musiime V; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Bbuye D; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Ahimbisibwe GM; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Chalermpantmetagul S; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Ali S; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Sarfati T; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Wynne B; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Shakeshaft C; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Colbers A; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Klein N; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Bernays S; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Saïdi Y; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Coelho A; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Grossele T; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Compagnucci A; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Giaquinto C; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Rojo P; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Ford D; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
  • Gibb DM; From the Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology (A.T., E.W., S.A., T.S., B.W., C.S., D.F., D.M.G.), the University College London Great Ormond Street Institute of Child Health (N.K.), and the Department of Global Healt
N Engl J Med ; 385(27): 2531-2543, 2021 12 30.
Article en En | MEDLINE | ID: mdl-34965338
ABSTRACT

BACKGROUND:

Children with human immunodeficiency virus type 1 (HIV-1) infection have limited options for effective antiretroviral treatment (ART).

METHODS:

We conducted an open-label, randomized, noninferiority trial comparing three-drug ART based on the HIV integrase inhibitor dolutegravir with standard care (non-dolutegravir-based ART) in children and adolescents starting first- or second-line ART. The primary end point was the proportion of participants with virologic or clinical treatment failure by 96 weeks, as estimated by the Kaplan-Meier method. Safety was assessed.

RESULTS:

From September 2016 through June 2018, a total of 707 children and adolescents who weighed at least 14 kg were randomly assigned to receive dolutegravir-based ART (350 participants) or standard care (357). The median age was 12.2 years (range, 2.9 to 18.0), the median weight was 30.7 kg (range, 14.0 to 85.0), and 49% of the participants were girls. By design, 311 participants (44%) started first-line ART (with 92% of those in the standard-care group receiving efavirenz-based ART), and 396 (56%) started second-line ART (with 98% of those in the standard-care group receiving boosted protease inhibitor-based ART). The median follow-up was 142 weeks. By 96 weeks, 47 participants in the dolutegravir group and 75 in the standard-care group had treatment failure (estimated probability, 0.14 vs. 0.22; difference, -0.08; 95% confidence interval, -0.14 to -0.03; P = 0.004). Treatment effects were similar with first- and second-line therapies (P = 0.16 for heterogeneity). A total of 35 participants in the dolutegravir group and 40 in the standard-care group had at least one serious adverse event (P = 0.53), and 73 and 86, respectively, had at least one adverse event of grade 3 or higher (P = 0.24). At least one ART-modifying adverse event occurred in 5 participants in the dolutegravir group and in 17 in the standard-care group (P = 0.01).

CONCLUSIONS:

In this trial involving children and adolescents with HIV-1 infection who were starting first- or second-line treatment, dolutegravir-based ART was superior to standard care. (Funded by ViiV Healthcare; ODYSSEY ClinicalTrials.gov number, NCT02259127; EUDRACT number, 2014-002632-14; and ISRCTN number, ISRCTN91737921.).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Oxazinas / Piperazinas / Piridonas / Infecciones por VIH / VIH-1 / Inhibidores de Integrasa VIH / Antirretrovirales / Compuestos Heterocíclicos con 3 Anillos Tipo de estudio: Clinical_trials Límite: Adolescent / Child / Child, preschool / Female / Humans / Male Idioma: En Revista: N Engl J Med Año: 2021 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Oxazinas / Piperazinas / Piridonas / Infecciones por VIH / VIH-1 / Inhibidores de Integrasa VIH / Antirretrovirales / Compuestos Heterocíclicos con 3 Anillos Tipo de estudio: Clinical_trials Límite: Adolescent / Child / Child, preschool / Female / Humans / Male Idioma: En Revista: N Engl J Med Año: 2021 Tipo del documento: Article