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  1. AU="Nampota, Nginache"
  2. AU="de Carvalho, Vinicius S"
  3. AU=Eisen Michael B
  4. AU="Manal S. Selim" AU="Manal S. Selim"
  5. AU="Alturki, Ramadan"
  6. AU="Kluger, Benzi"
  7. AU="Mitchell, Krista"
  8. AU="Oakes, Mary"
  9. AU="Kevill, Dennis N"
  10. AU="Rojas, Almudena"
  11. AU=Dalmau Josep AU=Dalmau Josep
  12. AU="Vaňáčová, Štěpánka"
  13. AU="Hancioglu, Baris"
  14. AU="Scribner, Kim T"
  15. AU="Emanuel Schmassmann"
  16. AU="Patel, Monica"
  17. AU=Passariello Margherita
  18. AU=Saikia Bedangshu
  19. AU="Dion, Dominique"
  20. AU="Magami, Shunsuke"
  21. AU="Wagner, Henrik"

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  1. Artikel ; Online: Isoniazid preventive therapy-related adverse events among Malawian adults on antiretroviral therapy: A cohort study.

    Tsirizani-Galileya, Lufina / Milanzi, Elasma / Mungwira, Randy / Divala, Titus / Mallewa, Jane / Mategula, Donnie / Nampota, Nginache / Mwapasa, Victor / Buchwald, Andrea / Laurens, Matthew B / Laufer, Miriam K / Van Oosterhout, Joep J

    Medicine

    2022  Band 101, Heft 39, Seite(n) e30591

    Abstract: Adverse events may be a cause of observed poor completion of isoniazid preventive therapy (IPT) among people living with HIV in high tuberculosis burden areas. Data on IPT-related adverse events (AE) from sub-Saharan Africa are scarce. We report IPT- ... ...

    Abstract Adverse events may be a cause of observed poor completion of isoniazid preventive therapy (IPT) among people living with HIV in high tuberculosis burden areas. Data on IPT-related adverse events (AE) from sub-Saharan Africa are scarce. We report IPT-related AEs, associated clinical characteristics, and IPT discontinuations in adults who were stable on antiretroviral therapy (ART) when they initiated IPT. Cohort study nested within a randomized, controlled, clinical trial of cotrimoxazole and chloroquine prophylaxis in Malawians aged ≥ 18 years and virologically suppressed on ART. Eight hundred sixty-nine patients were followed for a median of 6 months after IPT initiation. IPT relatedness of AEs was determined retrospectively with the World Health Organization case-causality tool. Frailty survival regression modeling identified factors associated with time to first probably IPT-related AE. The overall IPT-related AE incidence rate was 1.1/person year of observation. IPT relatedness was mostly uncertain and few AEs were severe. Most common were liver and hematological toxicities. Higher age increased risk of a probably IPT-related AE (aHR = 1.02; 95% CI 1.00-1.06; P = .06) and higher weight reduced this risk (aHR = 0.98; 95% CI 0.96-1.00; P = .03). Of 869 patients, 114 (13%) discontinued IPT and 94/114 (82%) discontinuations occurred at the time of a possibly or probably IPT-related AE. We observed a high incidence of mostly mild IPT-related AEs among individuals who were stable on ART. More than 1 in 8 persons discontinued IPT. These findings inform strategies to improve implementation of IPT in adults on ART, including close monitoring of groups at higher risk of IPT-related AEs.
    Mesh-Begriff(e) Adult ; Antitubercular Agents/adverse effects ; Chloroquine/therapeutic use ; Cohort Studies ; HIV Infections/epidemiology ; Humans ; Isoniazid/adverse effects ; Retrospective Studies ; Trimethoprim, Sulfamethoxazole Drug Combination/therapeutic use
    Chemische Substanzen Antitubercular Agents ; Trimethoprim, Sulfamethoxazole Drug Combination (8064-90-2) ; Chloroquine (886U3H6UFF) ; Isoniazid (V83O1VOZ8L)
    Sprache Englisch
    Erscheinungsdatum 2022-09-30
    Erscheinungsland United States
    Dokumenttyp Journal Article ; Randomized Controlled Trial
    ZDB-ID 80184-7
    ISSN 1536-5964 ; 0025-7974
    ISSN (online) 1536-5964
    ISSN 0025-7974
    DOI 10.1097/MD.0000000000030591
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel ; Online: Revisiting Co-trimoxazole Prophylaxis for African Adults in the Era of Antiretroviral Therapy: A Randomized Controlled Clinical Trial.

    Laurens, Matthew B / Mungwira, Randy G / Nampota, Nginache / Nyirenda, Osward M / Divala, Titus H / Kanjala, Maxwell / Mkandawire, Felix A / Galileya, Lufina Tsirizani / Nyangulu, Wongani / Mwinjiwa, Edson / Downs, Matthew / Tillman, Amy / Taylor, Terrie E / Mallewa, Jane / Plowe, Christopher V / van Oosterhout, Joep J / Laufer, Miriam K

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2021  Band 73, Heft 6, Seite(n) 1058–1065

    Abstract: Background: Daily co-trimoxazole is recommended for African adults living with human immunodeficiency virus (HIV) irrespective of antiretroviral treatment, immune status, or disease stage. Benefits of continued prophylaxis and whether co-trimoxazole can ...

    Abstract Background: Daily co-trimoxazole is recommended for African adults living with human immunodeficiency virus (HIV) irrespective of antiretroviral treatment, immune status, or disease stage. Benefits of continued prophylaxis and whether co-trimoxazole can be stopped following immune reconstitution are unknown.
    Methods: We conducted a randomized controlled trial at 2 sites in Malawi that enrolled adults with HIV with undetectable viral load and CD4 count of >250/mm3 and randomized them to continue daily co-trimoxazole, discontinue daily co-trimoxazole and begin weekly chloroquine, or discontinue daily co-trimoxazole. The primary endpoint was the preventive effect of co-trimoxazole prophylaxis against death or World Health Organization (WHO) HIV/AIDS stage 3-4 events, using Cox proportional hazards modeling, in an intention-to-treat population.
    Results: 1499 adults were enrolled. The preventive effect of co-trimoxazole on the primary endpoint was 22% (95% CI: -14%-47%; P = .20) versus no prophylaxis and 25% (-10%-48%; P = .14) versus chloroquine. When WHO HIV/AIDS stage 2 events were added to the primary endpoint, preventive effect increased to 31% (3-51%; P = .032) and 32% (4-51%; P = .026), respectively. Co-trimoxazole and chloroquine prophylaxis effectively prevented clinical malaria episodes (3.8 and 3.0, respectively, vs 28/100 person-years; P < .001).
    Conclusions: Malawian adults with HIV who immune reconstituted on ART and continued co-trimoxazole prophylaxis experienced fewer deaths and WHO HIV/AIDS stage 3-4 events compared with prophylaxis discontinuation, although statistical significance was not achieved. Co-trimoxazole prevented a composite of death plus WHO HIV/AIDS stage 2-4 events. Given poor healthcare access and lack of routine viral load monitoring, co-trimoxazole prophylaxis should continue in adults on ART after immune reconstitution in sub-Saharan Africa. Clinical Trials Registration. NCT01650558.
    Mesh-Begriff(e) Adult ; Anti-Retroviral Agents/therapeutic use ; CD4 Lymphocyte Count ; HIV Infections/drug therapy ; HIV Infections/prevention & control ; Humans ; Malawi/epidemiology ; Trimethoprim, Sulfamethoxazole Drug Combination/therapeutic use
    Chemische Substanzen Anti-Retroviral Agents ; Trimethoprim, Sulfamethoxazole Drug Combination (8064-90-2)
    Sprache Englisch
    Erscheinungsdatum 2021-03-17
    Erscheinungsland United States
    Dokumenttyp Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciab252
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel ; Online: Safety and Efficacy of a Typhoid Conjugate Vaccine in Malawian Children.

    Patel, Priyanka D / Patel, Pratiksha / Liang, Yuanyuan / Meiring, James E / Misiri, Theresa / Mwakiseghile, Felistas / Tracy, J Kathleen / Masesa, Clemens / Msuku, Harrison / Banda, David / Mbewe, Maurice / Henrion, Marc / Adetunji, Fiyinfolu / Simiyu, Kenneth / Rotrosen, Elizabeth / Birkhold, Megan / Nampota, Nginache / Nyirenda, Osward M / Kotloff, Karen /
    Gmeiner, Markus / Dube, Queen / Kawalazira, Gift / Laurens, Matthew B / Heyderman, Robert S / Gordon, Melita A / Neuzil, Kathleen M

    The New England journal of medicine

    2021  Band 385, Heft 12, Seite(n) 1104–1115

    Abstract: Background: Typhoid fever caused by multidrug-resistant H58 : Methods: We conducted a phase 3, double-blind trial in Blantyre, Malawi, to assess the efficacy of Vi polysaccharide typhoid conjugate vaccine (Vi-TCV). We randomly assigned children who ... ...

    Abstract Background: Typhoid fever caused by multidrug-resistant H58
    Methods: We conducted a phase 3, double-blind trial in Blantyre, Malawi, to assess the efficacy of Vi polysaccharide typhoid conjugate vaccine (Vi-TCV). We randomly assigned children who were between 9 months and 12 years of age, in a 1:1 ratio, to receive a single dose of Vi-TCV or meningococcal capsular group A conjugate (MenA) vaccine. The primary outcome was typhoid fever confirmed by blood culture. We report vaccine efficacy and safety outcomes after 18 to 24 months of follow-up.
    Results: The intention-to-treat analysis included 28,130 children, of whom 14,069 were assigned to receive Vi-TCV and 14,061 were assigned to receive the MenA vaccine. Blood culture-confirmed typhoid fever occurred in 12 children in the Vi-TCV group (46.9 cases per 100,000 person-years) and in 62 children in the MenA group (243.2 cases per 100,000 person-years). Overall, the efficacy of Vi-TCV was 80.7% (95% confidence interval [CI], 64.2 to 89.6) in the intention-to-treat analysis and 83.7% (95% CI, 68.1 to 91.6) in the per-protocol analysis. In total, 130 serious adverse events occurred in the first 6 months after vaccination (52 in the Vi-TCV group and 78 in the MenA group), including 6 deaths (all in the MenA group). No serious adverse events were considered by the investigators to be related to vaccination.
    Conclusions: Among Malawian children 9 months to 12 years of age, administration of Vi-TCV resulted in a lower incidence of blood culture-confirmed typhoid fever than the MenA vaccine. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT03299426.).
    Mesh-Begriff(e) Child ; Child, Preschool ; Double-Blind Method ; Female ; Follow-Up Studies ; Humans ; Incidence ; Infant ; Intention to Treat Analysis ; Malawi ; Male ; Meningococcal Vaccines/adverse effects ; Polysaccharides, Bacterial/adverse effects ; Salmonella typhi ; Typhoid Fever/epidemiology ; Typhoid Fever/prevention & control ; Typhoid-Paratyphoid Vaccines/adverse effects ; Vaccines, Conjugate
    Chemische Substanzen Meningococcal Vaccines ; Polysaccharides, Bacterial ; Typhoid-Paratyphoid Vaccines ; Vaccines, Conjugate ; Vi polysaccharide vaccine, typhoid
    Sprache Englisch
    Erscheinungsdatum 2021-09-15
    Erscheinungsland United States
    Dokumenttyp Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMoa2035916
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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