A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)
A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
2 other identifiers
observational
6,000
24 countries
221
Brief Summary
The purpose of this study is to compare two ways of using anti-HIV drugs to help health care providers and patients decide how to best use anti-HIV treatments over many years. Many health care providers now treat patients with daily drugs to keep the viral load as low as possible. This approach helps patients with CD4 counts less than 200-250 cells/mm3 live longer without serious diseases. But it is not known if this is the best way to treat patients with higher CD4 counts. There is information suggesting that these patients may be able to wait to use anti-HIV drugs while CD4 counts are above 250 cells/mm3. Because this study will be carried out over several years, it will provide information on the long-term advantages and disadvantages of these two treatment strategies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
221 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2001
CompletedFirst Posted
Study publicly available on registry
December 5, 2001
CompletedNovember 25, 2009
December 1, 2008
December 4, 2001
November 24, 2009
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- HIV infection
- CD4 cell count greater than 350 cells/mm3 within 45 days of study entry
- Willing to start, change, or stop antiretroviral therapy
- Acceptable methods of contraception
- Good health at the time of study entry
- Available for the study for at least 6 months
- Able, in the clinician's opinion, to comply with the protocol
You may not qualify if:
- Currently participating in the MDR-HIV, NvR study, or another study which is not consistent with one of the treatment groups in this study. CPCRA FIRST participants may be screened for SMART after August 8, 2005 and can be randomized into SMART on or after September 19, 2005.
- Pregnant or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (223)
Kaiser Permanente-Fremont/Hayward Medical Centers
Fremont, California, 94538, United States
AIDS Healthcare Foundation
Los Angeles, California, 90015, United States
Los Angeles Gay and Lesbian Community Service Ctr
Los Angeles, California, 90028, United States
Community Consortium / UCSF
San Francisco, California, 94110, United States
Dr. Shawn Hassler
San Francisco, California, 94110, United States
East Bay AIDS Ctr
San Francisco, California, 94110, United States
Lawrence Goldyn, MD
San Francisco, California, 94110, United States
Drs. Lichtenstein & Greenberg
Denver, Colorado, 80204-4507, United States
Western Infectious Disease Consultants
Denver, Colorado, 80204-4507, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507, United States
McDowell Healthcare Center
Denver, Colorado, 80204, United States
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
New Haven, Connecticut, 065102483, United States
Veterans Administration Medical Center
New Haven, Connecticut, 06510, United States
Christiana Care Health Services HIV Program George
Wilmington, Delaware, 19801, United States
Timothy A Price
Washington D.C., District of Columbia, 204220001, United States
George Washington Univ
Washington D.C., District of Columbia, 20422, United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422, United States
Miami Veterans Affairs Med Ctr
Miami, Florida, 33125, United States
Center for Prevention and Treatment of Infections
Pensacola, Florida, 32504, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960, United States
Absolute Care Clinic
Atlanta, Georgia, 30308, United States
AID Atlanta/Morehouse Med School Ryan White Cl
Atlanta, Georgia, 30308, United States
AIDS Research Consortium of Atlanta (ARCA) Central
Atlanta, Georgia, 30308, United States
Cobb-Douglas County Infectious Disease Clinic
Atlanta, Georgia, 30308, United States
Dekalb County Health Dept Infectious Disease
Atlanta, Georgia, 30308, United States
Dr. Dennis Melton (Private Practice)
Atlanta, Georgia, 30308, United States
Dr. Melanie Thompson and Dr. Annette Bernard (Private Practice)
Atlanta, Georgia, 30308, United States
Dr. Richard Hudson (Private Practice)
Atlanta, Georgia, 30308, United States
HIV Services Clinic/Family Practice Medical Center
Boise, Idaho, 83704, United States
Cook County Hosp
Chicago, Illinois, 606576156, United States
Klein and Slotten Associates / AIDS Research Alliance
Chicago, Illinois, 606576156, United States
Lakeshore Infectious Disease Associates
Chicago, Illinois, 606576156, United States
University of Illinois at Chicago
Chicago, Illinois, 606576156, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657, United States
Northside Family Medicine
Chicago, Illinois, 60657, United States
Northwestern Memorial Physicians
Chicago, Illinois, 60657, United States
University of Chicago
Chicago, Illinois, 60657, United States
Southern Illinois University (SIU) School of Medicine
Springfield, Illinois, 62702, United States
KU Medical School-Wichita, Midtown Clinic
Wichita, Kansas, 37214-3199, United States
KU Medical School-Wichita, MPA
Wichita, Kansas, 37214-3199, United States
University of Mississippi Medical Center
New Orleans, Louisiana, 70112-2699, United States
Our Lady of the Lake Regional Med Ctr
New Orleans, Louisiana, 701122699, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112, United States
Community Research Initiatives of New England
Boston, Massachusetts, 02215, United States
Community Research Initiatives/ProACT
Boston, Massachusetts, 02215, United States
Community Research Initiative/ProACT
Springfield, Massachusetts, 01107, United States
University of Michigan Health System
Ann Arbor, Michigan, 48100-0378, United States
Detroit Community Health Connection
Detroit, Michigan, 48201, United States
Detroit Receiving
Detroit, Michigan, 48201, United States
Wayne State Univ / Medical College of Ohio at Toledo
Detroit, Michigan, 48201, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
Mt. Clemens General Hospital
Detroit, Michigan, 48202, United States
Providence Hosp- Newland Med Assoc. Inc.
Detroit, Michigan, 48202, United States
McAuley Health Center
Grand Rapids, Michigan, 49503, United States
Michigan State University Infectious Diseases Clinic
Lansing, Michigan, 48910, United States
William Beaumont Hospital/CORNET
Royal Oak, Michigan, 48073, United States
Mayo Clinic/CORNET
Rochester, Minnesota, 55905, United States
Cooper Hospital Early Intervention Program
Camden, New Jersey, 08103, United States
Jersey Shore Med Ctr
Neptune City, New Jersey, 07753, United States
Raritan Bay Med Ctr
Newark, New Jersey, 071032842, United States
Saint Michael's Med Ctr
Newark, New Jersey, 071032842, United States
Jeffrey Bomser Clinic / NJCR
Newark, New Jersey, 07103, United States
New Jersey Community Research Initiative
Newark, New Jersey, 07103, United States
NJCRI
Newark, New Jersey, 07103, United States
South Jersey Infectious Disease
Somers Poinnt, New Jersey, 08244, United States
SUNY Downstate Med Ctr
Brooklyn, New York, 11023, United States
Grant Houses Health Ctr
New York, New York, 10037, United States
HHC MMC Unit #1
New York, New York, 10037, United States
HHC Outpatient Clinics
New York, New York, 10037, United States
Jacobi Medical Center
New York, New York, 10037, United States
Lenox Avenue Health Ctr
New York, New York, 10037, United States
Lincoln Medical & Mental Health Center
New York, New York, 10037, United States
Polo Grounds Health Care Ctr
New York, New York, 10037, United States
Syndenham Neighborhood Family Care Ctr
New York, New York, 10037, United States
Metropolitan Hospital Center
New York, New York, 10039, United States
Bronx-Lebanon Hosp Ctr
The Bronx, New York, 10453, United States
Bronx Veterans Affairs Medical Center
The Bronx, New York, 10468, United States
Wake Forest Univ Health Sciences
Winston-Salem, North Carolina, 27157-1042, United States
Univ of Oklahoma Health Sciences
Oklahoma City, Oklahoma, 73104, United States
Legacy Clinic NE
Portland, Oregon, 97209-2534, United States
Salem Hospital
Portland, Oregon, 97209-2534, United States
The Research & Education Group / Multomah Cnty Hlth Dept
Portland, Oregon, 972105311, United States
The Research & Education Group / The R & E Grp Office
Portland, Oregon, 972105311, United States
The Research & Education Grp / Oregon Hlth Sci Univ
Portland, Oregon, 972105311, United States
The Rsch & Ed Grp / Legacy Cln at Good Samaritan
Portland, Oregon, 972105311, United States
The Rsch & Ed Grp / Providence Portland Med Ctr
Portland, Oregon, 972105311, United States
The Research and Education Group
Portland, Oregon, 97210, United States
Penn Community Infectious Diseases
Philadelphia, Pennsylvania, 19107, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19140, United States
Temple Univ School of Medicine
Philadelphia, Pennsylvania, 19140, United States
Montrose Clinic
Houston, Texas, 77006, United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030, United States
Univ TX Health Science Ctr
Houston, Texas, 77030, United States
University Clinical Research Center
Houston, Texas, 77030, United States
South Texas Veterans Health Care System
San Antonio, Texas, 78229, United States
Infectious Disease Associates of Virginia
Lynchburg, Virginia, 24501, United States
Cross Over Clinic / Div of Infectious Diseases
Richmond, Virginia, 232980049, United States
McGuire VA / Division of Infectious Diseases
Richmond, Virginia, 232980049, United States
MCV ID Clinic
Richmond, Virginia, 23298, United States
MediCorp, Infectious Disease Associates
Richmond, Virginia, 23298, United States
Petersburg Health Care Alliance
Richmond, Virginia, 23298, United States
South Richmond Health Ctr
Richmond, Virginia, 23298, United States
Vernon J. Harris East End Community Health Care Ct
Richmond, Virginia, 23298, United States
University Of Wisconsin Hospital and Clinics/CORNET, HIV Care Program
Madison, Wisconsin, 53792, United States
Hospital de Clinicas Jose de San Martin
Buenos Aires, Argentina
Hospital de Infecciosas F.J. Muniz
Buenos Aires, Argentina
Hospital Gn'l de Agudos JM Ramos Mejia
Buenos Aires, Argentina
Hospital Gn'l de Agudos T. Alvarez
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Hospital Rawson
Córdoba, Argentina
Hospital Interzonall de San Juan de Dios
La Plata, Argentina
Hospital Central
Mendoza, Argentina
CAICI
Rosario, Argentina
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Prahran Market Clinic
South Yarra, Victoria, Australia
The Centre Clinic
South Yarra, Victoria, Australia
Burwood Street General Pratice
Burwood Nsw, 2134, Australia
Royal Perth Hosp
Perth, Australia
Alfred Hosp
Prahan, Australia
Royal Prince Alfred Hospital
Prahan, Australia
National Centre in HIV Epidemiology and Clinical Research
Sydney, Australia
University of Vienna Medical School, AKH
Vienna, A-1090, Austria
Institute of Tropical Medicine
Antwerp, 2000, Belgium
Centre Hospitalier Universitaire Sart-Tilman
Liège, 4000, Belgium
Hospital Escola Sao Francisco de Asis
Rio de Janeiro, Rio de Janeiro, 20210.030, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Instituto de Infectologia Emilio Ribas
São Paulo, S.P. CEP, 01246, Brazil
Cassiano Antonio de Moraes University Hospital
Boqueirao-Santos, 11045-904, Brazil
Centro de Pesquisa Clinical do Hospital Guilherme
Boqueirao-Santos, 11045-904, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre-RS Cep, 90035, Brazil
Hospital dos Servidores do Estado
Rio de Janeiro, 20221-903, Brazil
Hospital Universitario Professor Edgard Santos
Salvador-BA, 110-160, Brazil
Ambulatorio de Imunodeficiencias Secundarias/Der30
São Paulo, 01246-900, Brazil
Universidade Federal De Sao Paulo-Hospital Sao Paulo
São Paulo, 04040-002, Brazil
Centro de Referencia e Treinamento DST/AIDS
São Paulo, 04121-000, Brazil
Unidade de Pesquisa Clinica
São Paulo, 13083-970, Brazil
Downtown Infectious Disease Clinic
Vancouver, British Columbia, V6Z 2C7, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, NS B3H 1V7, Canada
The HAVEN Program, HRSRH
Greater Sudbury, Ontario, P3E 5J1, Canada
Hamilton Health Science Centre-McMaster
Hamilton, Ontario, L8N 3Z5, Canada
St. Joseph's Health Care Centre of London
London, Ontario, N5Y 3H6, Canada
St. Josephs Hospital
London, Ontario, Canada
Tronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
HIV Care Program, Windsor Regional Hospital
Windsor, Ontario, N8W 1E3, Canada
University de Sherbrooke
Fleurimont, Quebec, JIH 5N4, Canada
Clinique Medicale L'actuel
Montreal, Quebec, H2L 4P9, Canada
Montreal Chest Institute/Royal Victoria Hospital
Montreal, Quebec, H2X 2P4, Canada
Centre hospitalier de l'universite Laval (CHUL)
Sainte-Foy, Quebec, F1V 4G2, Canada
Recherche Clinique Centre Medical Halles de Saint-
Ste-Foy, Quebec, G1V 4P9, Canada
West-Tallinn Central Hospital
Tallinn, 10617, Estonia
CHU de la Region Annecienne
Annecy, 74011, France
Hopital Pellegrin
Bordeaux, 33076, France
Centre Hospitalier Universitaire
Chu-grenoble, France
Hopital Louis Mourier
Colombes, France
Hopital Sainte-Marguerite
Marseille, 13009, France
Hopital Saint-Louis
Paris, 75010, France
Hopital Pitie Salpetriere
Paris, 75651, France
Klinik fur Dermatologie, Venerologie, Allergologie
Essen, 45122, Germany
Johann Wolfgang Goethe University Hospital
Frankfurt am Main, 60590, Germany
Klinikum der Ruprecht-Karis-Universitat (U. Hospital)
Heidelberg, D-69115, Germany
University Hospital Zurich
Zurich Ch-, 8091, Germany
St. James Hospital
Dublin, Ireland
Ramathibodi Hospital
Tel Aviv, 64239, Israel
U.O. Malattie Infettive, H.S.Maria Annunziata
Antella-Firenze, 50011, Italy
SOCDU Malattie Infettive Ospedale Civile Asti
Asti, 14100, Italy
Instituto de Malattie Infettive e Tropicali
Brescia, I-25125, Italy
Malattie Infettive Busto
Busto Arsizio (va), 21052, Italy
Universita degli Studi di Modena e Reggio Emilia
Modena, 41100, Italy
Clinica Malattie Infettive
Pavia, 27100, Italy
I.R.C.C.S."L.Spallanzani"
Rome, 00149, Italy
University of Turin
Torino, 10149, Italy
Servizio Regionale di Immunologia Clinica e Tipizz
Torrette Di Ancona, 71-60020, Italy
S.S. Giovanni e Paolo Hospital
Venice, Italy
AIDS Medical Center, International Medical Center
Tokyo, 162-8655, Japan
International Medical Center of Japan
Tokyo, 162-8655, Japan
Lithuanian AIDS center
Vilnius, 03011, Lithuania
Centre Hospitalier de Luxembourg
Barble, L-1210, Luxembourg
C.H.U. Fort-de-France
Fort-de-France, 97261, Martinique
Christchurch Hosp
Christchurch, New Zealand
Wellington Hosp
Wellington, New Zealand
Ulleval Hospital
Oslo, N-0407, Norway
Hospital Nacional Edgardo Rebagliati Martins
Lima, 11, Peru
Hospital Nacional Guillermo Almenara Irigoyen
Lima, 13, Peru
Wroclaw University School of Medicine
Koszarowa Str. 5, Poland
Instituto A. Z. de Pesquisa e Ensino
Curitiba, 80430-040, Puerto Rico
Hospital de la Santa Creu i Sant Pau
Barcelona, E08025, Spain
Hospital Universitario de La Princesa
Madrid, E-28006, Spain
Hospital Universitario Principe de Asturias
Madrid, E-28805, Spain
Hospital U. Virgen del Rocio
Seville, 41013, Spain
Hospital Mutua de Terrassa
Terrassa, 08221, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, 46014, Spain
University Hospital Basel
Basel Ch, 4031, Switzerland
Poliklinik fur Infektiologie
Bern, 3010, Switzerland
Hopital de la Ville
La Chaux-de-Fonds, 2300, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011, Switzerland
Ospedale Regionale di Lugano
Lugano, 6903, Switzerland
Sanpatong Hospital
Chiang Mai, 50120, Thailand
Bamrasnaradura Institute
Nonthaburi, Thailand
John Radcliffe Hospital
Oxford, England, OX3 9DU, United Kingdom
Royal Victoria Hospital
Belfast, BT12 6BA, United Kingdom
Hawthorn House, Birmingham Heartlands NHS Trust
Birmingham, B9 5SS, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
St. Helier Hospital
Carshalton, SM5, 1AA, United Kingdom
St. Helier Hospital
Carshalton, Surrey, SM5, 1AA, United Kingdom
Essex County Hospital
Essex, CO3 3NB, United Kingdom
Victoria General Hospital, Q.E. II Health Sciences
Halifax, United Kingdom
Homerton University Hospital NHS Foundation Trust
London, E9 6SR, United Kingdom
Barts and The London, NHS Trust
London, EC1A 7BE, United Kingdom
Central Middlesex Hospital
London, NW10 7NS, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
St. Thomas' Hospital
London, SE1 7EH, United Kingdom
T1 Coleridge Unit, North Middlesex Hospital
London, SE5 9RS, United Kingdom
The Caldecot Centre, Kings College Hospital NHS Tr
London, SE5 9RS, United Kingdom
Chelsea and Westminster Hospital
London, SW10 9NH, United Kingdom
St. George's Hospital
London, SW17 ORE, United Kingdom
St. Mary's Hospital
London, W1 2NY, United Kingdom
The Mortimer Market Center
London, WC1E 6AU, United Kingdom
The James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Pasteur Suite, Ealing Hospital
Middlesex, UB1 3HW, United Kingdom
Newcastle General Hospital
Newcastle, NE4 6BE, United Kingdom
Dept. of Infection and Tropical Medicine - Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
Watford Sexual Health Center;Watford General Hosp
Watford Wd, 18 0HB, United Kingdom
Related Publications (35)
Lederman MM, Valdez H. Immune restoration with antiretroviral therapies: implications for clinical management. JAMA. 2000 Jul 12;284(2):223-8. doi: 10.1001/jama.284.2.223.
PMID: 10889597BACKGROUNDCarpenter CC, Cooper DA, Fischl MA, Gatell JM, Gazzard BG, Hammer SM, Hirsch MS, Jacobsen DM, Katzenstein DA, Montaner JS, Richman DD, Saag MS, Schechter M, Schooley RT, Thompson MA, Vella S, Yeni PG, Volberding PA. Antiretroviral therapy in adults: updated recommendations of the International AIDS Society-USA Panel. JAMA. 2000 Jan 19;283(3):381-90. doi: 10.1001/jama.283.3.381.
PMID: 10647802BACKGROUNDMocroft A, Katlama C, Johnson AM, Pradier C, Antunes F, Mulcahy F, Chiesi A, Phillips AN, Kirk O, Lundgren JD. AIDS across Europe, 1994-98: the EuroSIDA study. Lancet. 2000 Jul 22;356(9226):291-6. doi: 10.1016/s0140-6736(00)02504-6.
PMID: 11071184BACKGROUNDTebas P, Henry K, Mondy K, Deeks S, Valdez H, Cohen C, Powderly WG. Effect of prolonged discontinuation of successful antiretroviral therapy on CD4+ T cell decline in human immunodeficiency virus-infected patients: implications for intermittent therapeutic strategies. J Infect Dis. 2002 Sep 15;186(6):851-4. doi: 10.1086/342603. Epub 2002 Aug 28.
PMID: 12198623BACKGROUNDYerly S, Kaiser L, Perneger TV, Cone RW, Opravil M, Chave JP, Furrer H, Hirschel B, Perrin L. Time of initiation of antiretroviral therapy: impact on HIV-1 viraemia. The Swiss HIV Cohort Study. AIDS. 2000 Feb 18;14(3):243-9. doi: 10.1097/00002030-200002180-00006.
PMID: 10716500BACKGROUNDBorges AH, Neuhaus J, Sharma S, Neaton JD, Henry K, Anagnostou O, Staub T, Emery S, Lundgren JD; INSIGHT SMART; START Study Groups. The Effect of Interrupted/Deferred Antiretroviral Therapy on Disease Risk: A SMART and START Combined Analysis. J Infect Dis. 2019 Jan 7;219(2):254-263. doi: 10.1093/infdis/jiy442.
PMID: 30032171DERIVEDCastillo-Mancilla JR, Phillips AN, Neaton JD, Neuhaus J, Collins S, Mannheimer S, Pett S, Touzeau-Romer V, Polizzotto MN, Lundgren JD, Gardner EM; INSIGHT SMART Study Group. Association of Suboptimal Antiretroviral Therapy Adherence With Inflammation in Virologically Suppressed Individuals Enrolled in the SMART Study. Open Forum Infect Dis. 2017 Dec 22;5(1):ofx275. doi: 10.1093/ofid/ofx275. eCollection 2018 Jan.
PMID: 29362724DERIVEDLarson GS, Carey C, Grarup J, Hudson F, Sachi K, Vjecha MJ, Gordin F; INSIGHT Group. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials. 2016 Apr;13(2):127-36. doi: 10.1177/1740774515625974. Epub 2016 Feb 8.
PMID: 26908541DERIVEDNordell AD, McKenna M, Borges AH, Duprez D, Neuhaus J, Neaton JD; INSIGHT SMART, ESPRIT Study Groups; SILCAAT Scientific Committee. Severity of cardiovascular disease outcomes among patients with HIV is related to markers of inflammation and coagulation. J Am Heart Assoc. 2014 May 28;3(3):e000844. doi: 10.1161/JAHA.114.000844.
PMID: 24870935DERIVEDLucas GM, Cozzi-Lepri A, Wyatt CM, Post FA, Bormann AM, Crum-Cianflone NF, Ross MJ; INSIGHT SMART Study Group. Glomerular filtration rate estimated using creatinine, cystatin C or both markers and the risk of clinical events in HIV-infected individuals. HIV Med. 2014 Feb;15(2):116-23. doi: 10.1111/hiv.12087. Epub 2013 Sep 11.
PMID: 24024499DERIVEDBaker JV, Brummel-Ziedins K, Neuhaus J, Duprez D, Cummins N, Dalmau D, DeHovitz J, Lehmann C, Sullivan A, Woolley I, Kuller L, Neaton JD, Tracy RP; INSIGHT SMART Study Team. HIV replication alters the composition of extrinsic pathway coagulation factors and increases thrombin generation. J Am Heart Assoc. 2013 Jul 29;2(4):e000264. doi: 10.1161/JAHA.113.000264.
PMID: 23896681DERIVEDHoy J, Grund B, Roediger M, Ensrud KE, Brar I, Colebunders R, Castro ND, Johnson M, Sharma A, Carr A; INSIGHT SMART Body Composition Substudy Group. Interruption or deferral of antiretroviral therapy reduces markers of bone turnover compared with continuous therapy: The SMART body composition substudy. J Bone Miner Res. 2013 Jun;28(6):1264-74. doi: 10.1002/jbmr.1861.
PMID: 23299909DERIVEDZetterberg E, Neuhaus J, Baker JV, Somboonwit C, Llibre JM, Palfreeman A, Chini M, Lundgren JD; INSIGHT SMART Study Group. Platelet count kinetics following interruption of antiretroviral treatment. AIDS. 2013 Jan 2;27(1):59-68. doi: 10.1097/QAD.0b013e32835a104d.
PMID: 23018440DERIVEDMocroft A, Neuhaus J, Peters L, Ryom L, Bickel M, Grint D, Koirala J, Szymczak A, Lundgren J, Ross MJ, Wyatt CM; INSIGHT SMART Study Group; ESPRIT Study Group. Hepatitis B and C co-infection are independent predictors of progressive kidney disease in HIV-positive, antiretroviral-treated adults. PLoS One. 2012;7(7):e40245. doi: 10.1371/journal.pone.0040245. Epub 2012 Jul 20.
PMID: 22911697DERIVEDBaker JV, Neuhaus J, Duprez D, Cooper DA, Hoy J, Kuller L, Lampe FC, Liappis A, Friis-Moller N, Otvos J, Paton NI, Tracy R, Neaton JD; INSIGHT SMART Study Group. Inflammation predicts changes in high-density lipoprotein particles and apolipoprotein A1 following initiation of antiretroviral therapy. AIDS. 2011 Nov 13;25(17):2133-42. doi: 10.1097/QAD.0b013e32834be088.
PMID: 21857489DERIVEDMocroft A, Lifson AR, Touloumi G, Neuhaus J, Fox Z, Palfreeman A, Vjecha MJ, Hodder S, De Wit S, Lundgren JD, Phillips AN; INSIGHT SMART Study Group. Haemoglobin and anaemia in the SMART study. Antivir Ther. 2011;16(3):329-37. doi: 10.3851/IMP1746.
PMID: 21555815DERIVEDDuprez DA, Neuhaus J, Tracy R, Kuller LH, Deeks SG, Orkin C, Stoehr A, Woolley IJ, Neaton JD; INSIGHT SMART Group. N-terminal-proB-type natriuretic peptide predicts cardiovascular disease events in HIV-infected patients. AIDS. 2011 Mar 13;25(5):651-7. doi: 10.1097/QAD.0b013e32834404a1.
PMID: 21245726DERIVEDLampe FC, Duprez DA, Kuller LH, Tracy R, Otvos J, Stroes E, Cooper DA, Hoy J, Paton NI, Friis-Moller N, Neuhaus J, Liappis AP, Phillips AN; INSIGHT SMART Study Group. Changes in lipids and lipoprotein particle concentrations after interruption of antiretroviral therapy. J Acquir Immune Defic Syndr. 2010 Jul;54(3):275-84. doi: 10.1097/qai.0b013e3181d32158.
PMID: 20658749DERIVEDDore GJ, Soriano V, Rockstroh J, Kupfer B, Tedaldi E, Peters L, Neuhaus J, Puoti M, Klein MB, Mocroft A, Clotet B, Lundgren JD; SMART INSIGHT study group. Frequent hepatitis B virus rebound among HIV-hepatitis B virus-coinfected patients following antiretroviral therapy interruption. AIDS. 2010 Mar 27;24(6):857-65. doi: 10.1097/QAD.0b013e328334bddb.
PMID: 20216301DERIVEDRodger AJ, Fox Z, Lundgren JD, Kuller LH, Boesecke C, Gey D, Skoutelis A, Goetz MB, Phillips AN; INSIGHT Strategies for Management of Antiretroviral Therapy (SMART) Study Group. Activation and coagulation biomarkers are independent predictors of the development of opportunistic disease in patients with HIV infection. J Infect Dis. 2009 Sep 15;200(6):973-83. doi: 10.1086/605447.
PMID: 19678756DERIVEDGrund B, Peng G, Gibert CL, Hoy JF, Isaksson RL, Shlay JC, Martinez E, Reiss P, Visnegarwala F, Carr AD; INSIGHT SMART Body Composition Substudy Group. Continuous antiretroviral therapy decreases bone mineral density. AIDS. 2009 Jul 31;23(12):1519-29. doi: 10.1097/QAD.0b013e32832c1792.
PMID: 19531929DERIVEDDuprez DA, Kuller LH, Tracy R, Otvos J, Cooper DA, Hoy J, Neuhaus J, Paton NI, Friis-Moller N, Lampe F, Liappis AP, Neaton JD; INSIGHT SMART Study Group. Lipoprotein particle subclasses, cardiovascular disease and HIV infection. Atherosclerosis. 2009 Dec;207(2):524-9. doi: 10.1016/j.atherosclerosis.2009.05.001. Epub 2009 May 13.
PMID: 19515371DERIVEDMocroft A, Wyatt C, Szczech L, Neuhaus J, El-Sadr W, Tracy R, Kuller L, Shlipak M, Angus B, Klinker H, Ross M; INSIGHT SMART Study Group. Interruption of antiretroviral therapy is associated with increased plasma cystatin C. AIDS. 2009 Jan 2;23(1):71-82. doi: 10.1097/QAD.0b013e32831cc129.
PMID: 19050388DERIVEDFox Z, Phillips A, Cohen C, Neuhaus J, Baxter J, Emery S, Hirschel B, Hullsiek KH, Stephan C, Lundgren J; SMART Study Group. Viral resuppression and detection of drug resistance following interruption of a suppressive non-nucleoside reverse transcriptase inhibitor-based regimen. AIDS. 2008 Nov 12;22(17):2279-89. doi: 10.1097/QAD.0b013e328311d16f.
PMID: 18981767DERIVEDTedaldi E, Peters L, Neuhaus J, Puoti M, Rockstroh J, Klein MB, Dore GJ, Mocroft A, Soriano V, Clotet B, Lundgren JD; SMART Study Group and International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). Opportunistic disease and mortality in patients coinfected with hepatitis B or C virus in the strategic management of antiretroviral therapy (SMART) study. Clin Infect Dis. 2008 Dec 1;47(11):1468-75. doi: 10.1086/593102.
PMID: 18959492DERIVEDKuller LH, Tracy R, Belloso W, De Wit S, Drummond F, Lane HC, Ledergerber B, Lundgren J, Neuhaus J, Nixon D, Paton NI, Neaton JD; INSIGHT SMART Study Group. Inflammatory and coagulation biomarkers and mortality in patients with HIV infection. PLoS Med. 2008 Oct 21;5(10):e203. doi: 10.1371/journal.pmed.0050203.
PMID: 18942885DERIVEDSMART Study Group; El-Sadr WM, Grund B, Neuhaus J, Babiker A, Cohen CJ, Darbyshire J, Emery S, Lundgren JD, Phillips A, Neaton JD. Risk for opportunistic disease and death after reinitiating continuous antiretroviral therapy in patients with HIV previously receiving episodic therapy: a randomized trial. Ann Intern Med. 2008 Sep 2;149(5):289-99. doi: 10.7326/0003-4819-149-5-200809020-00003.
PMID: 18765698DERIVEDStrategies for Management of Anti-Retroviral Therapy/INSIGHT; DAD Study Groups. Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients. AIDS. 2008 Sep 12;22(14):F17-24. doi: 10.1097/QAD.0b013e32830fe35e.
PMID: 18753925DERIVEDGordin FM, Roediger MP, Girard PM, Lundgren JD, Miro JM, Palfreeman A, Rodriguez-Barradas MC, Wolff MJ, Easterbrook PJ, Clezy K, Slater LN. Pneumonia in HIV-infected persons: increased risk with cigarette smoking and treatment interruption. Am J Respir Crit Care Med. 2008 Sep 15;178(6):630-6. doi: 10.1164/rccm.200804-617OC. Epub 2008 Jul 10.
PMID: 18617640DERIVEDPhillips AN, Carr A, Neuhaus J, Visnegarwala F, Prineas R, Burman WJ, Williams I, Drummond F, Duprez D, Belloso WH, Goebel FD, Grund B, Hatzakis A, Vera J, Lundgren JD. Interruption of antiretroviral therapy and risk of cardiovascular disease in persons with HIV-1 infection: exploratory analyses from the SMART trial. Antivir Ther. 2008;13(2):177-87. doi: 10.1177/135965350801300215.
PMID: 18505169DERIVEDStrategies for Management of Antiretroviral Therapy (SMART) Study Group; Lundgren JD, Babiker A, El-Sadr W, Emery S, Grund B, Neaton JD, Neuhaus J, Phillips AN. Inferior clinical outcome of the CD4+ cell count-guided antiretroviral treatment interruption strategy in the SMART study: role of CD4+ Cell counts and HIV RNA levels during follow-up. J Infect Dis. 2008 Apr 15;197(8):1145-55. doi: 10.1086/529523.
PMID: 18476293DERIVEDStrategies for Management of Antiretroviral Therapy (SMART) Study Group; Emery S, Neuhaus JA, Phillips AN, Babiker A, Cohen CJ, Gatell JM, Girard PM, Grund B, Law M, Losso MH, Palfreeman A, Wood R. Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study. J Infect Dis. 2008 Apr 15;197(8):1133-44. doi: 10.1086/586713.
PMID: 18476292DERIVEDCarr A, Grund B, Neuhaus J, El-Sadr WM, Grandits G, Gibert C, Prineas RJ; SMART Study Investigators. Asymptomatic myocardial ischaemia in HIV-infected adults. AIDS. 2008 Jan 11;22(2):257-67. doi: 10.1097/QAD.0b013e3282f20a77.
PMID: 18097228DERIVEDBurman WJ, Grund B, Roediger MP, Friedland G, Darbyshire J, Wu AW; SMART Study Group. The impact of episodic CD4 cell count-guided antiretroviral therapy on quality of life. J Acquir Immune Defic Syndr. 2008 Feb 1;47(2):185-93. doi: 10.1097/QAI.0b013e31815acaa4.
PMID: 17971716DERIVEDStrategies for Management of Antiretroviral Therapy (SMART) Study Group; El-Sadr WM, Lundgren J, Neaton JD, Gordin F, Abrams D, Arduino RC, Babiker A, Burman W, Clumeck N, Cohen CJ, Cohn D, Cooper D, Darbyshire J, Emery S, Fatkenheuer G, Gazzard B, Grund B, Hoy J, Klingman K, Losso M, Markowitz N, Neuhaus J, Phillips A, Rappoport C. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med. 2006 Nov 30;355(22):2283-96. doi: 10.1056/NEJMoa062360.
PMID: 17135583DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wafaa El-Sadr, MD, MPH
Harlem AIDS Treatment Group, Harlem Hospital Center
- STUDY CHAIR
James Neaton, PhD
CPCRA Statistcal and Data Management Center / CCBR
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 4, 2001
First Posted
December 5, 2001
Last Updated
November 25, 2009
Record last verified: 2008-12