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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Risk for opportunistic disease and death after reinitiating continuous antiretroviral therapy in patients with HIV previously receiving episodic therapy: A randomized trial
Annals of Internal Medicine, Volume 149, No. 5, Year 2008
Notification
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Description
Background: Episodic use of antiretroviral therapy guided by CD4 + cell counts is inferior to continuous antiretroviral therapy. Objective: To determine whether reinitiating continuous antiretroviral therapy in patients who received episodic treatment reduces excess risk for opportunistic disease or death. Design: Randomized, controlled trial. Setting: Sites in 33 countries. Patients: 5472 HIV-infected individuals with CD4 + cell counts greater than 0.350 × 109 cells/L enrolled from January 2002 to January 2006. Intervention: Episodic or continuous antiretroviral therapy initially, followed by continuous therapy in participants previously assigned to episodic treatment. Measurements: Opportunistic disease or death was the primary outcome. Results: Eighteen months after the recommendation to reinitiate continuous therapy, mean CD4+ cell counts were 0.152 × 109 cells/L (95% CI, 0.136 to 0.167 × 109 cells/L) less in participants previously assigned to episodic treatment (P < 0.001). The proportion of follow-up time spent with CD4+ cell counts of 0.500 × 109 cells/L or more and HIV RNA levels of 400 copies/mL or less was 29% for participants initially assigned to episodic therapy and 66% for those assigned to continuous therapy. Participants who reinitiated continuous therapy experienced rapid suppression of HIV RNA levels (89.7% with HIV RNA levels ≤400 copies/mL after 6 months), but CD4+ cell counts after 6 months remained 0.140 × 10 9 cells/L below baseline. The hazard ratio (episodic versus continuous treatment) for opportunistic disease or death decreased after the recommendation to reinitiate continuous therapy (from 2.5 [CI, 1.8 to 3.5] to 1.4 [CI, 1.0 to 2.0]; P = 0.033 for difference). The residual excess risk was attributable to failure to reinitiate therapy by some participants and slow recovery of CD4+ cell counts for those who reinitiated therapy. Limitation: Follow-up was too short to assess the full effect of switching from episodic to continuous antiretroviral therapy. Conclusion: Reinitiating continuous antiretroviral therapy in patients previously assigned to episodic treatment reduced excess risk for opportunistic disease or death, but excess risk remained. Episodic antiretroviral therapy, as used in the SMART study, should be avoided. © 2008 American College of Physicians.
Authors & Co-Authors
El-Sadr, W. M.
United States, New York
Harlem Hospital Center
Grund, Birgit
United States, Minneapolis
School of Public Health
Neaton, James D.
United States, Minneapolis
School of Public Health
Neuhaus, Jacqueline A.
United States, Minneapolis
School of Public Health
Cohen, Calvin J.
United States, Boston
Community Research Initiative of new England
Darbyshire, Janet H.
United Kingdom, London
Medical Research Council
Babiker, Abdel G.A.G.
United Kingdom, London
Medical Research Council
Emery, Sean
Australia, Sydney
Unsw Sydney
Lundgren, Jens D.
Denmark, Copenhagen
Rigshospitalet
Phillips, Andrew N.
United Kingdom, London
University College London
Jensen, Karoline B.
Unknown Affiliation
Borup, Liselotte
Unknown Affiliation
Pearson, Mary T.
Unknown Affiliation
Jansson, Per Olof
Unknown Affiliation
Jensen, Birgitte Gram
Unknown Affiliation
Fox, Zoë V.
Unknown Affiliation
Phillips, Andrew N.
Unknown Affiliation
Babiker, A. G.
Unknown Affiliation
Palfreeman, Adrian J.
Unknown Affiliation
Fleck, Sue L.
Unknown Affiliation
Dodds, Wendy
Unknown Affiliation
Cordwell, B.
Unknown Affiliation
van Hooff, Fionna
Unknown Affiliation
Collaço-Moraes, Yolanda
Unknown Affiliation
Angus, Brian John
Unknown Affiliation
Cooper, David A.
Unknown Affiliation
Drummond, Fraser M.
Unknown Affiliation
Connor, S. A.
Unknown Affiliation
Satchell, Claudette S.
Unknown Affiliation
Gunn, S.
Unknown Affiliation
Oka, Shinichi
Unknown Affiliation
Delfino, Marina A.
Unknown Affiliation
Merlin, Kate M.
Unknown Affiliation
McGinley, Ciara
Unknown Affiliation
Gordin, Fred M.
Unknown Affiliation
Finley, Elizabeth B.
Unknown Affiliation
Dietz, D.
Unknown Affiliation
Chesson, Charles E.
Unknown Affiliation
Vjecha, Michael J.
Unknown Affiliation
Standridge, Barbara
Unknown Affiliation
Bartsch, G.
Unknown Affiliation
DuChêne, Alain G.
Unknown Affiliation
George, Michael
Unknown Affiliation
Krum, Eric A.
Unknown Affiliation
Larson, Gregg S.
Unknown Affiliation
Miller, Christopher J.
Unknown Affiliation
Nelson, Ray
Unknown Affiliation
Roediger, M. P.
Unknown Affiliation
Schultz, Terri
Unknown Affiliation
Prineas, Ronald J.
Unknown Affiliation
Campbell, Colin N.J.
Unknown Affiliation
Pérez, George
Unknown Affiliation
Lifson, Alan Raymond
Unknown Affiliation
Duprez, Daniel A.
Unknown Affiliation
Hoy, Jennifer F.
Unknown Affiliation
Lahart, Christopher J.
Unknown Affiliation
Perlman, David H.
Unknown Affiliation
Price, Richard W.
Unknown Affiliation
Rhame, Frank S.
Unknown Affiliation
Sampson, J.
Unknown Affiliation
Worley, John
Unknown Affiliation
DerSimonian, Rebecca R.
Unknown Affiliation
Brody, B. A.
Unknown Affiliation
Daar, Eric S.
Unknown Affiliation
Dubler, Nancy Neveloff
Unknown Affiliation
Fleming, Thomas R.
Unknown Affiliation
Freeman, D. J.
Unknown Affiliation
Kahn, Jeffrey P.
Unknown Affiliation
Kim, Kyungmann
Unknown Affiliation
Medoff, G.
Unknown Affiliation
Modlin, John F.
Unknown Affiliation
Moellering, R.
Unknown Affiliation
Murray, B. E.
Unknown Affiliation
Pick, Billy
Unknown Affiliation
Robb, Merlin Lee
Unknown Affiliation
Scharfstein, Daniel O.
Unknown Affiliation
Sugarman, Jeremy
Unknown Affiliation
Tsiatis, Anastasios Butch
Unknown Affiliation
Tuazon, Carmelita U.
Unknown Affiliation
Zoloth, L.
Unknown Affiliation
Klingman, Karin L.
Unknown Affiliation
Lehrman, Sandra Nusinoff
Unknown Affiliation
Lazovski, Jaime
Unknown Affiliation
Belloso, Waldo Horacio
Unknown Affiliation
Losso, Marcelo Horacio
Unknown Affiliation
Benetucci, Jorge A.
Unknown Affiliation
Cahn, Pedro Enrique
Unknown Affiliation
Cassetti, Isabel
Unknown Affiliation
Corral, Jorge A.
Unknown Affiliation
Crinejo, Ana
Unknown Affiliation
David, Daniel O.
Unknown Affiliation
Krolewiecki, Alejandro Javier
Unknown Affiliation
Laplumé, Héctor E.
Unknown Affiliation
Lupo, Sergio Horacio
Unknown Affiliation
Hoy, Jennifer F.
Unknown Affiliation
Anderson, Jonathan St C.
Unknown Affiliation
Barnes, Kathleen C.
Unknown Affiliation
Carr, Andrew D.
Unknown Affiliation
Chuah, John C.P.
Unknown Affiliation
Donohue, William A.
Unknown Affiliation
Doong, Nicholas C.
Unknown Affiliation
Dwyer, Dominic Edmund
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French, Martyn A.H.
Unknown Affiliation
Garsia, Roger J.
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Gold, Julian
Unknown Affiliation
Konecny, Pam
Unknown Affiliation
Moore, Richard James
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Piper, Margaret A.
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Roney, Janine J.
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Roth, Norman J.
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Silvers, Julie Elizabeth
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Smith, David J.
Unknown Affiliation
Street, Alan C.
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Youds, David W.
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Rieger, Armin C.
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Aichelburg, Alexander C.
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Vetter, Norbert
Unknown Affiliation
Clumeck, Nathan N.
Unknown Affiliation
de Roo, Ann
Unknown Affiliation
Lynen, Lutgarde
Unknown Affiliation
Schechter, Mauro T.
Unknown Affiliation
Brites, Carlos R.
Unknown Affiliation
Caseiro, Marcos Montani
Unknown Affiliation
Madruga, José Valdez Ramalho
Unknown Affiliation
Reuter, Tania Queiroz
Unknown Affiliation
Sidi, Leon Claude
Unknown Affiliation
Ellis, Matthew James C.
Unknown Affiliation
Haase, David A.
Unknown Affiliation
Klein, Marina Barbara
Unknown Affiliation
Schlech, Walter F.
Unknown Affiliation
Smaill, Fiona Mary
Unknown Affiliation
Trottier, Sylvie
Unknown Affiliation
Walmsley, Sharon Lynn
Unknown Affiliation
Wolff Reyes, Marcelo J.
Unknown Affiliation
Østergaard, Lars Jørgen
Unknown Affiliation
Pedersen, Court K.
Unknown Affiliation
Ristola, M.
Unknown Affiliation
Girard, Pierre Marie
Unknown Affiliation
Landman, Roland
Unknown Affiliation
Abgrall, Sophie
Unknown Affiliation
Benalycherif, Aïda
Unknown Affiliation
Bentata, Michelle
Unknown Affiliation
Besnier, Jean Marc
Unknown Affiliation
Bouchaud, Olivier
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Cabiè, André Crossed Dsign©
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Chennebault, Jean Marie
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Durant, Jacques M.
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Gérard, Laurence
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Gilquin, Jacques M.
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Hoën, Bruno
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Jeantils, Vincent
Unknown Affiliation
Michon, Christopher P.
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Pacanowski, Jérôme
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Poizot-Martin, Isabelle
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Salmon, Dominique
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Simon, Anne Laure
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Tassi, Sylvie
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Verdón, Renault
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Weinbreck, Pierre
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Weiss, Laurence L.
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Yazdanpanah, Yazdan
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Yéni, Patrick G.
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Fätkenheuer, Gerd
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Staszewski, Schlomo
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Bogner, Johannes Richard
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Brockmeyer, Norbert Hermann
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Esser, Stefan
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Goebel, Frank Detlef
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Klinker, Hartwig H.F.
Unknown Affiliation
Lehmann, Clara
Unknown Affiliation
Lennemann, Tessa Suntje
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Rockstroh, Jürgen Kurt
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Stoehr, Albrecht
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Wasmuth, Jan Christian
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Hatzakis, Angelos E.
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Touloumi, Giota
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Antoniadou, Anastasia C.
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Daikos, Georgios L.
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Katsarou, Olga I.
Unknown Affiliation
Kordossis, Theodoros
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Lazanas, Marios C.
Unknown Affiliation
Papastamopoulos, V.
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Skoutelis, Athamasios
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Pollack, Shimon
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Agmon-Levin, Nancy
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Kedem, Eynat
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Maayan, Sholomo L.
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Shahar, Eduardo
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Sthoeger, Zed M.
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Turner, David P.J.
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Tambussi, Giuseppe
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Carosi, Giaampiero
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Casari, Salvatore
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Nozza, Silvia
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Quirino, Tiziana
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Schmit, Jean Claude
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Staub, Thérèse
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Himmich, Hakima
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Marhoum El Filali, Kamal
Unknown Affiliation
Mills, Graham D.
Unknown Affiliation
la Rosa, Alberto M.
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Horban, Andrzéj
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Ba̧kowska, Elżbieta
Unknown Affiliation
Beniowski, Marek
Unknown Affiliation
Antunes, Francisco
Unknown Affiliation
Mansinho, Kamal
Unknown Affiliation
Valadas, Emília
Unknown Affiliation
Rakhmanova, Aza Gasanovna
Unknown Affiliation
Yakovlev, Alexey A.
Unknown Affiliation
Zakharova, Natalia V.
Unknown Affiliation
Wood, Robin Y.
Unknown Affiliation
Clotet, Bonaventura
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Dalmau, David
Unknown Affiliation
Pulido, F.
Unknown Affiliation
Sanz, Jesuìs L.
Unknown Affiliation
Hirschel, Bernard J.
Unknown Affiliation
Battegay, Manuel
Unknown Affiliation
Bernasconi, Enos
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Cavassini, Matthias
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Furrer, Hansjakob Jackob
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Gayet-Ageron, Angèle
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Müller, Nicolas J.
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Phanuphak, Praphan
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Ruxrungtham, Kiat
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Pumpradit, Wadchara
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Chetchotisakd, Ploenchan
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Kiertiburanakul, Sasisopin
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Klinbuayaem, Virat
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Piyavong, Bucha
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Gazzard, Brian G.
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Ainsworth, Jonathan G.
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Anderson, Jane S.C.
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Brook, Michael Gary
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Chadwick, David Robert
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Churchill, Duncan R.
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Easterbrook, Philippa Jane
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Fox, Raymond
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Gompels, Mark M.
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Jackson, Akil G.A.
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Johnson, Margaret A.
Unknown Affiliation
Kuldanek, Kristin A.
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Leen, Clifford L.S.
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Mantell, Joanne E.
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Morris, Sheila
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Orkin, Chloë M.
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Peters, Bjoern S.
Unknown Affiliation
Peto, Timothy E.A.
Unknown Affiliation
Portsmouth, Simon D.
Unknown Affiliation
Ronan, Agnes
Unknown Affiliation
Schwenk, Achim
Unknown Affiliation
Wansbrough-Jones, Mark H.
Unknown Affiliation
Williams, Elizabeth Dixon
Unknown Affiliation
Williams, Ian G.
Unknown Affiliation
Youle, Mike S.
Unknown Affiliation
Adams, Stuart Paul
Unknown Affiliation
Andrews, Laurie A.
Unknown Affiliation
Arduino, Roberto C.
Unknown Affiliation
Baxter, John D.
Unknown Affiliation
Bolan, Robert Key
Unknown Affiliation
Brown, Shawn K.
Unknown Affiliation
Clark, Clifford G.
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DeHovitz, Jack A.
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Unknown Affiliation
Estes, Mary Kolb
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Flynn, Harry W.
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Friedland, Gerald H.
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Bidwell Goetz, Matthew Bidwell
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Hennessey, Karen A.
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Hodder, Sally L.
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Johnson, Debra L.
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Johnson, Gordon J.
Unknown Affiliation
Johnson, Leigh
Unknown Affiliation
Kostman, Jay R.
Unknown Affiliation
Kumar, Amit Ganesh
Unknown Affiliation
Lucasti, Christopher J.
Unknown Affiliation
Mannheimer, Sharon B.
Unknown Affiliation
Markowitz, Norman P.
Unknown Affiliation
Martínez, Núria E.
Unknown Affiliation
Mogyoros, Miguel
Unknown Affiliation
Mushatt, David M.
Unknown Affiliation
Nixon, Daniel E.
Unknown Affiliation
O'Brien, Stephen J.
Unknown Affiliation
Oldfïeld, Edward C.
Unknown Affiliation
Ortiz, Roberto
Unknown Affiliation
Paul, Stéphane
Unknown Affiliation
Pelz, Robert K.
Unknown Affiliation
Pierone, Gerald
Unknown Affiliation
Rimland, David
Unknown Affiliation
Rodriguez-Barradas, Maria C.
Unknown Affiliation
Scott, Callie A.
Unknown Affiliation
Scott, Rachel K.
Unknown Affiliation
Sension, Michael G.
Unknown Affiliation
Shuter, Jonathan
Unknown Affiliation
Somboonwit, Charurut
Unknown Affiliation
Tedaldi, Ellen M.
Unknown Affiliation
Telzak, Edward E.
Unknown Affiliation
Temesgen, Zelalem M.
Unknown Affiliation
Thompson, Melanie A.
Unknown Affiliation
Thompson, Simon G.
Unknown Affiliation
Uy, Jonathan P.
Unknown Affiliation
Vecino, Isabel
Unknown Affiliation
Weis, Stephen E.
Unknown Affiliation
Wilkin, Aimee M.
Unknown Affiliation
Young, Benjamin
Unknown Affiliation
Statistics
Citations: 142
Authors: 304
Affiliations: 7
Identifiers
Doi:
10.7326/0003-4819-149-5-200809020-00003
ISSN:
00034819
Research Areas
Environmental
Infectious Diseases
Study Design
Randomised Control Trial
Cohort Study