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PMID- 28723333
OWN - NLM
STAT- MEDLINE
DA  - 20170720
DCOM- 20170801
LR  - 20170801
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Linking)
VI  - 377
IP  - 3
DP  - 2017 Jul 20
TI  - Enhanced Prophylaxis plus Antiretroviral Therapy for Advanced HIV Infection in
      Africa.
PG  - 233-245
LID - 10.1056/NEJMoa1615822 [doi]
AB  - BACKGROUND: In sub-Saharan Africa, among patients with advanced human
      immunodeficiency virus (HIV) infection, the rate of death from infection
      (including tuberculosis and cryptococcus) shortly after the initiation of
      antiretroviral therapy (ART) is approximately 10%. METHODS: In this factorial
      open-label trial conducted in Uganda, Zimbabwe, Malawi, and Kenya, we enrolled
      HIV-infected adults and children 5 years of age or older who had not received
      previous ART and were starting ART with a CD4+ count of fewer than 100 cells per 
      cubic millimeter. They underwent simultaneous randomization to receive enhanced
      antimicrobial prophylaxis or standard prophylaxis, adjunctive raltegravir or no
      raltegravir, and supplementary food or no supplementary food. Here, we report on 
      the effects of enhanced antimicrobial prophylaxis, which consisted of continuous 
      trimethoprim-sulfamethoxazole plus at least 12 weeks of isoniazid-pyridoxine
      (coformulated with trimethoprim-sulfamethoxazole in a single fixed-dose
      combination tablet), 12 weeks of fluconazole, 5 days of azithromycin, and a
      single dose of albendazole, as compared with standard prophylaxis
      (trimethoprim-sulfamethoxazole alone). The primary end point was 24-week
      mortality. RESULTS: A total of 1805 patients (1733 adults and 72 children or
      adolescents) underwent randomization to receive either enhanced prophylaxis (906 
      patients) or standard prophylaxis (899 patients) and were followed for 48 weeks
      (loss to follow-up, 3.1%). The median baseline CD4+ count was 37 cells per cubic 
      millimeter, but 854 patients (47.3%) were asymptomatic or mildly symptomatic. In 
      the Kaplan-Meier analysis at 24 weeks, the rate of death with enhanced
      prophylaxis was lower than that with standard prophylaxis (80 patients [8.9% vs. 
      108 [12.2%]; hazard ratio, 0.73; 95% confidence interval [CI], 0.55 to 0.98;
      P=0.03); 98 patients (11.0%) and 127 (14.4%), respectively, had died by 48 weeks 
      (hazard ratio, 0.76; 95% CI, 0.58 to 0.99; P=0.04). Patients in the
      enhanced-prophylaxis group had significantly lower rates of tuberculosis
      (P=0.02), cryptococcal infection (P=0.01), oral or esophageal candidiasis
      (P=0.02), death of unknown cause (P=0.03), and new hospitalization (P=0.03).
      However, there was no significant between-group difference in the rate of severe 
      bacterial infection (P=0.32). There were nonsignificantly lower rates of serious 
      adverse events and grade 4 adverse events in the enhanced-prophylaxis group
      (P=0.08 and P=0.09, respectively). Rates of HIV viral suppression and adherence
      to ART were similar in the two groups. CONCLUSIONS: Among HIV-infected patients
      with advanced immunosuppression, enhanced antimicrobial prophylaxis combined with
      ART resulted in reduced rates of death at both 24 weeks and 48 weeks without
      compromising viral suppression or increasing toxic effects. (Funded by the
      Medical Research Council and others; REALITY Current Controlled Trials number,
      ISRCTN43622374 .).
FAU - Hakim, James
AU  - Hakim J
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Musiime, Victor
AU  - Musiime V
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Szubert, Alex J
AU  - Szubert AJ
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Mallewa, Jane
AU  - Mallewa J
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Siika, Abraham
AU  - Siika A
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Agutu, Clara
AU  - Agutu C
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Walker, Simon
AU  - Walker S
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Pett, Sarah L
AU  - Pett SL
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Bwakura-Dangarembizi, Mutsa
AU  - Bwakura-Dangarembizi M
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Lugemwa, Abbas
AU  - Lugemwa A
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Kaunda, Symon
AU  - Kaunda S
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Karoney, Mercy
AU  - Karoney M
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Musoro, Godfrey
AU  - Musoro G
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Kabahenda, Sheila
AU  - Kabahenda S
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Nathoo, Kusum
AU  - Nathoo K
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Maitland, Kathryn
AU  - Maitland K
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Griffiths, Anna
AU  - Griffiths A
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Thomason, Margaret J
AU  - Thomason MJ
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Kityo, Cissy
AU  - Kityo C
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Mugyenyi, Peter
AU  - Mugyenyi P
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Prendergast, Andrew J
AU  - Prendergast AJ
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Walker, A Sarah
AU  - Walker AS
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
FAU - Gibb, Diana M
AU  - Gibb DM
AD  - From the University of Zimbabwe Clinical Research Center, Harare, Zimbabwe (J.H.,
      M.B.-D., G.M., K.N.); Joint Clinical Research Center, Kampala (V.M., C.K., P.M.),
      Mbarara (A.L.), and Fort Portal (S. Kabahenda) - all in Uganda; Medical Research 
      Council Clinical Trials Unit at University College London (A.J.S., S.L.P., A.G., 
      M.J.T., A.S.W., D.M.G.), Wellcome Trust Centre for Clinical Tropical Medicine and
      Department of Paediatrics, Imperial College (K.M.), and Queen Mary University of 
      London (A.J.P.), London, and the Centre for Health Economics, University of York,
      York (S.W.) - all in the United Kingdom; the Department of Medicine and
      Malawi-Liverpool-Wellcome Trust Clinical Research Program, Blantyre, Malawi
      (J.M., S. Kaunda); and Moi University School of Medicine, Eldoret (A.S., M.K.),
      and the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Program,
      Kilifi (C.A., K.M.) - both in Kenya.
CN  - REALITY Trial Team
LA  - eng
SI  - ISRCTN/ISRCTN43622374
GR  - Medical Research Council/United Kingdom
GR  - Wellcome Trust/United Kingdom
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
RN  - 0 (Anti-Infective Agents)
RN  - 0 (Anti-Retroviral Agents)
RN  - 8064-90-2 (Trimethoprim, Sulfamethoxazole Drug Combination)
RN  - KV2JZ1BI6Z (Pyridoxine)
RN  - V83O1VOZ8L (Isoniazid)
SB  - AIM
SB  - IM
CIN - N Engl J Med. 2017 Jul 20;377(3):283-284. PMID: 28723319
MH  - AIDS-Related Opportunistic Infections/*prevention & control
MH  - Adolescent
MH  - Adult
MH  - Africa South of the Sahara/epidemiology
MH  - Aged
MH  - Anti-Infective Agents/adverse effects/*therapeutic use
MH  - Anti-Retroviral Agents/adverse effects/*therapeutic use
MH  - CD4 Lymphocyte Count
MH  - Child
MH  - Drug Therapy, Combination
MH  - Female
MH  - HIV Infections/*drug therapy/mortality
MH  - Humans
MH  - Isoniazid/therapeutic use
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Pyridoxine/therapeutic use
MH  - Trimethoprim, Sulfamethoxazole Drug Combination/therapeutic use
MH  - Young Adult
IR  - Musiime V
FIR - Musiime, V
IR  - Wavamunno P
FIR - Wavamunno, P
IR  - Nambi E
FIR - Nambi, E
IR  - Ocitti P
FIR - Ocitti, P
IR  - Ndigendawani M
FIR - Ndigendawani, M
IR  - Kemigisa M
FIR - Kemigisa, M
IR  - Acen J
FIR - Acen, J
IR  - Olebo D
FIR - Olebo, D
IR  - Mpamize G
FIR - Mpamize, G
IR  - Amone A
FIR - Amone, A
IR  - Okweny D
FIR - Okweny, D
IR  - Mbonye A
FIR - Mbonye, A
IR  - Nambaziira F
FIR - Nambaziira, F
IR  - Rweyora A
FIR - Rweyora, A
IR  - Kangah M
FIR - Kangah, M
IR  - Kabaswahili V
FIR - Kabaswahili, V
IR  - Abach J
FIR - Abach, J
IR  - Abongomera G
FIR - Abongomera, G
IR  - Omongin J
FIR - Omongin, J
IR  - Aciro I
FIR - Aciro, I
IR  - Philliam A
FIR - Philliam, A
IR  - Arach B
FIR - Arach, B
IR  - Ocung E
FIR - Ocung, E
IR  - Amone G
FIR - Amone, G
IR  - Miles P
FIR - Miles, P
IR  - Adong C
FIR - Adong, C
IR  - Tumsuiime C
FIR - Tumsuiime, C
IR  - Kidega P
FIR - Kidega, P
IR  - Otto B
FIR - Otto, B
IR  - Apio F
FIR - Apio, F
IR  - Baleeta K
FIR - Baleeta, K
IR  - Mukuye A
FIR - Mukuye, A
IR  - Abwola M
FIR - Abwola, M
IR  - Ssennono F
FIR - Ssennono, F
IR  - Baliruno D
FIR - Baliruno, D
IR  - Tuhirwe S
FIR - Tuhirwe, S
IR  - Namisi R
FIR - Namisi, R
IR  - Kigongo F
FIR - Kigongo, F
IR  - Kikyonkyo D
FIR - Kikyonkyo, D
IR  - Mushahara F
FIR - Mushahara, F
IR  - Tusiime J
FIR - Tusiime, J
IR  - Musiime A
FIR - Musiime, A
IR  - Nankya A
FIR - Nankya, A
IR  - Atwongyeire D
FIR - Atwongyeire, D
IR  - Sirikye S
FIR - Sirikye, S
IR  - Mula S
FIR - Mula, S
IR  - Noowe N
FIR - Noowe, N
IR  - Kasozi M
FIR - Kasozi, M
IR  - Mwebe S
FIR - Mwebe, S
IR  - Atwine L
FIR - Atwine, L
IR  - Senkindu T
FIR - Senkindu, T
IR  - Natuhurira T
FIR - Natuhurira, T
IR  - Katemba C
FIR - Katemba, C
IR  - Ninsiima E
FIR - Ninsiima, E
IR  - Acaku M
FIR - Acaku, M
IR  - Kyomuhangi J
FIR - Kyomuhangi, J
IR  - Ankunda R
FIR - Ankunda, R
IR  - Tukwasibwe D
FIR - Tukwasibwe, D
IR  - Ayesiga L
FIR - Ayesiga, L
IR  - Reid A
FIR - Reid, A
IR  - Chidziva E
FIR - Chidziva, E
IR  - Mhute T
FIR - Mhute, T
IR  - Tinago GC
FIR - Tinago, G C
IR  - Bhiri J
FIR - Bhiri, J
IR  - Mudzingwa S
FIR - Mudzingwa, S
IR  - Phiri M
FIR - Phiri, M
IR  - Steamer J
FIR - Steamer, J
IR  - Nhema R
FIR - Nhema, R
IR  - Warambwa C
FIR - Warambwa, C
IR  - Mutsai S
FIR - Mutsai, S
IR  - Nemasango B
FIR - Nemasango, B
IR  - Moyo C
FIR - Moyo, C
IR  - Chitongo S
FIR - Chitongo, S
IR  - Rashirai K
FIR - Rashirai, K
IR  - Vhembo S
FIR - Vhembo, S
IR  - Mlambo B
FIR - Mlambo, B
IR  - Nkomani S
FIR - Nkomani, S
IR  - Ndemera B
FIR - Ndemera, B
IR  - Willard M
FIR - Willard, M
IR  - Berejena C
FIR - Berejena, C
IR  - Musodza Y
FIR - Musodza, Y
IR  - Matiza P
FIR - Matiza, P
IR  - Mudenge B
FIR - Mudenge, B
IR  - Guti V
FIR - Guti, V
IR  - Etyang A
FIR - Etyang, A
IR  - Berkley J
FIR - Berkley, J
IR  - Njuguna P
FIR - Njuguna, P
IR  - Mwaringa S
FIR - Mwaringa, S
IR  - Etyang T
FIR - Etyang, T
IR  - Awuondo K
FIR - Awuondo, K
IR  - Wale S
FIR - Wale, S
IR  - Shangala J
FIR - Shangala, J
IR  - Kithunga J
FIR - Kithunga, J
IR  - Mwarumba S
FIR - Mwarumba, S
IR  - Said Maitha S
FIR - Said Maitha, S
IR  - Mutai R
FIR - Mutai, R
IR  - Lozi Lewa M
FIR - Lozi Lewa, M
IR  - Mwambingu G
FIR - Mwambingu, G
IR  - Mwanzu A
FIR - Mwanzu, A
IR  - Kalama C
FIR - Kalama, C
IR  - Latham H
FIR - Latham, H
IR  - Shikuku J
FIR - Shikuku, J
IR  - Fondo A
FIR - Fondo, A
IR  - Njogu A
FIR - Njogu, A
IR  - Khadenge C
FIR - Khadenge, C
IR  - Mwakisha B
FIR - Mwakisha, B
IR  - Siika A
FIR - Siika, A
IR  - Wools-Kaloustian K
FIR - Wools-Kaloustian, K
IR  - Nyandiko W
FIR - Nyandiko, W
IR  - Cheruiyot P
FIR - Cheruiyot, P
IR  - Sudoi A
FIR - Sudoi, A
IR  - Wachira S
FIR - Wachira, S
IR  - Meli B
FIR - Meli, B
IR  - Nzioka A
FIR - Nzioka, A
IR  - Tanui M
FIR - Tanui, M
IR  - Mokaya M
FIR - Mokaya, M
IR  - Ekiru W
FIR - Ekiru, W
IR  - Mboya C
FIR - Mboya, C
IR  - Mwimali D
FIR - Mwimali, D
IR  - Mengich C
FIR - Mengich, C
IR  - Choge J
FIR - Choge, J
IR  - Injera W
FIR - Injera, W
IR  - Njenga K
FIR - Njenga, K
IR  - Cherutich S
FIR - Cherutich, S
IR  - Anyango Orido M
FIR - Anyango Orido, M
IR  - Omondi Lwande G
FIR - Omondi Lwande, G
IR  - Rutto P
FIR - Rutto, P
IR  - Mudogo A
FIR - Mudogo, A
IR  - Kutto I
FIR - Kutto, I
IR  - Shali A
FIR - Shali, A
IR  - Jaika L
FIR - Jaika, L
IR  - Jerotich H
FIR - Jerotich, H
IR  - Pierre M
FIR - Pierre, M
IR  - Van Oosterhout J
FIR - Van Oosterhout, J
IR  - O'Hare B
FIR - O'Hare, B
IR  - Heydermann R
FIR - Heydermann, R
IR  - Gonzalez C
FIR - Gonzalez, C
IR  - Dzabala N
FIR - Dzabala, N
IR  - Kelly C
FIR - Kelly, C
IR  - Denis B
FIR - Denis, B
IR  - Selemani G
FIR - Selemani, G
IR  - Nyondo Mipando L
FIR - Nyondo Mipando, L
IR  - Chirwa E
FIR - Chirwa, E
IR  - Banda P
FIR - Banda, P
IR  - Mvula L
FIR - Mvula, L
IR  - Msuku H
FIR - Msuku, H
IR  - Ziwoya M
FIR - Ziwoya, M
IR  - Manda Y
FIR - Manda, Y
IR  - Nicholas S
FIR - Nicholas, S
IR  - Masesa C
FIR - Masesa, C
IR  - Mwalukomo T
FIR - Mwalukomo, T
IR  - Makhaza L
FIR - Makhaza, L
IR  - Sheha I
FIR - Sheha, I
IR  - Bwanali J
FIR - Bwanali, J
IR  - Limbuni M
FIR - Limbuni, M
IR  - Wilkes H
FIR - Wilkes, H
IR  - Rajapakse C
FIR - Rajapakse, C
IR  - Spyer M
FIR - Spyer, M
IR  - Klein N
FIR - Klein, N
IR  - Rauchenberger M
FIR - Rauchenberger, M
IR  - Van Looy N
FIR - Van Looy, N
IR  - Little E
FIR - Little, E
IR  - Fairbrother K
FIR - Fairbrother, K
IR  - Cowan F
FIR - Cowan, F
IR  - Seeley J
FIR - Seeley, J
IR  - Bernays S
FIR - Bernays, S
IR  - Kawuma R
FIR - Kawuma, R
IR  - Mupambireyi Z
FIR - Mupambireyi, Z
IR  - Kyomuhendo F
FIR - Kyomuhendo, F
IR  - Nakalanzi S
FIR - Nakalanzi, S
IR  - Peshu J
FIR - Peshu, J
IR  - Ndaa S
FIR - Ndaa, S
IR  - Chabuka J
FIR - Chabuka, J
IR  - Mkandawire N
FIR - Mkandawire, N
IR  - Matandika L
FIR - Matandika, L
IR  - Kapuya C
FIR - Kapuya, C
IR  - Weller I
FIR - Weller, I
IR  - Malianga E
FIR - Malianga, E
IR  - Mwansambo C
FIR - Mwansambo, C
IR  - Miiro F
FIR - Miiro, F
IR  - Elyanu P
FIR - Elyanu, P
IR  - Bukusi E
FIR - Bukusi, E
IR  - Katabira E
FIR - Katabira, E
IR  - Mugurungi O
FIR - Mugurungi, O
IR  - Peto T
FIR - Peto, T
IR  - Musoke P
FIR - Musoke, P
IR  - Matenga J
FIR - Matenga, J
IR  - Phiri S
FIR - Phiri, S
IR  - Lyall H
FIR - Lyall, H
IR  - Johnston V
FIR - Johnston, V
IR  - Fitzgerald F
FIR - Fitzgerald, F
IR  - Post F
FIR - Post, F
IR  - Ssali F
FIR - Ssali, F
IR  - Arenas-Pinto A
FIR - Arenas-Pinto, A
IR  - Turkova A
FIR - Turkova, A
IR  - Bamford A
FIR - Bamford, A
EDAT- 2017/07/21 06:00
MHDA- 2017/08/02 06:00
CRDT- 2017/07/21 06:00
AID - 10.1056/NEJMoa1615822 [doi]
PST - ppublish
SO  - N Engl J Med. 2017 Jul 20;377(3):233-245. doi: 10.1056/NEJMoa1615822.