AzTrials
AzTrials

HIV InfectionsNCT00027352

A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)

An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 223 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
HIV Infections
How many people
6,000 participants
Where
223 sitesin 26 countries
Study dates
Start not givento not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

223 sites in 26 countries.

223 sites in 26 countries

United States105 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48100-0378

  • Absolute Care Clinic

    Atlanta, Georgia, 30308

  • AID Atlanta/Morehouse Med School Ryan White Cl

    Atlanta, Georgia, 30308

  • AIDS Research Consortium of Atlanta (ARCA) Central

    Atlanta, Georgia, 30308

  • Cobb-Douglas County Infectious Disease Clinic

    Atlanta, Georgia, 30308

  • Dekalb County Health Dept Infectious Disease

    Atlanta, Georgia, 30308

  • Dr. Dennis Melton (Private Practice)

    Atlanta, Georgia, 30308

  • Dr. Melanie Thompson and Dr. Annette Bernard (Private Practice)

    Atlanta, Georgia, 30308

  • Dr. Richard Hudson (Private Practice)

    Atlanta, Georgia, 30308

  • HIV Services Clinic/Family Practice Medical Center

    Boise, Idaho, 83704

  • Community Research Initiatives of New England

    Boston, Massachusetts, 02215

  • Community Research Initiatives/ProACT

    Boston, Massachusetts, 02215

  • SUNY Downstate Med Ctr

    Brooklyn, New York, 11023

  • Cooper Hospital Early Intervention Program

    Camden, New Jersey, 08103

  • Cook County Hosp

    Chicago, Illinois, 606576156

  • Klein and Slotten Associates / AIDS Research Alliance

    Chicago, Illinois, 606576156

  • Lakeshore Infectious Disease Associates

    Chicago, Illinois, 606576156

  • University of Illinois at Chicago

    Chicago, Illinois, 606576156

  • AIDS Research Alliance - Chicago

    Chicago, Illinois, 60657

  • Northside Family Medicine

    Chicago, Illinois, 60657

  • Northwestern Memorial Physicians

    Chicago, Illinois, 60657

  • University of Chicago

    Chicago, Illinois, 60657

  • Drs. Lichtenstein & Greenberg

    Denver, Colorado, 80204-4507

  • Western Infectious Disease Consultants

    Denver, Colorado, 80204-4507

  • Denver CPCRA / Denver Public Hlth

    Denver, Colorado, 802044507

  • McDowell Healthcare Center

    Denver, Colorado, 80204

  • Detroit Community Health Connection

    Detroit, Michigan, 48201

  • Detroit Receiving

    Detroit, Michigan, 48201

  • Wayne State Univ / Medical College of Ohio at Toledo

    Detroit, Michigan, 48201

  • Henry Ford Hosp

    Detroit, Michigan, 48202

  • Mt. Clemens General Hospital

    Detroit, Michigan, 48202

  • Providence Hosp- Newland Med Assoc. Inc.

    Detroit, Michigan, 48202

  • Kaiser Permanente-Fremont/Hayward Medical Centers

    Fremont, California, 94538

  • McAuley Health Center

    Grand Rapids, Michigan, 49503

  • Montrose Clinic

    Houston, Texas, 77006

  • Houston Veterans Administration Med Ctr

    Houston, Texas, 77030

  • Univ TX Health Science Ctr

    Houston, Texas, 77030

  • University Clinical Research Center

    Houston, Texas, 77030

  • Michigan State University Infectious Diseases Clinic

    Lansing, Michigan, 48910

  • AIDS Healthcare Foundation

    Los Angeles, California, 90015

  • Los Angeles Gay and Lesbian Community Service Ctr

    Los Angeles, California, 90028

  • Infectious Disease Associates of Virginia

    Lynchburg, Virginia, 24501

  • University Of Wisconsin Hospital and Clinics/CORNET, HIV Care Program

    Madison, Wisconsin, 53792

  • Miami Veterans Affairs Med Ctr

    Miami, Florida, 33125

  • Jersey Shore Med Ctr

    Neptune City, New Jersey, 07753

  • Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit

    New Haven, Connecticut, 065102483

  • Veterans Administration Medical Center

    New Haven, Connecticut, 06510

  • University of Mississippi Medical Center

    New Orleans, Louisiana, 70112-2699

  • Our Lady of the Lake Regional Med Ctr

    New Orleans, Louisiana, 701122699

  • Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

    New Orleans, Louisiana, 70112

  • Grant Houses Health Ctr

    New York, New York, 10037

  • HHC MMC Unit #1

    New York, New York, 10037

  • HHC Outpatient Clinics

    New York, New York, 10037

  • Jacobi Medical Center

    New York, New York, 10037

  • Lenox Avenue Health Ctr

    New York, New York, 10037

  • Lincoln Medical & Mental Health Center

    New York, New York, 10037

  • Polo Grounds Health Care Ctr

    New York, New York, 10037

  • Syndenham Neighborhood Family Care Ctr

    New York, New York, 10037

  • Metropolitan Hospital Center

    New York, New York, 10039

  • Raritan Bay Med Ctr

    Newark, New Jersey, 071032842

  • Saint Michael's Med Ctr

    Newark, New Jersey, 071032842

  • Jeffrey Bomser Clinic / NJCR

    Newark, New Jersey, 07103

  • New Jersey Community Research Initiative

    Newark, New Jersey, 07103

  • NJCRI

    Newark, New Jersey, 07103

  • Univ of Oklahoma Health Sciences

    Oklahoma City, Oklahoma, 73104

  • Center for Prevention and Treatment of Infections

    Pensacola, Florida, 32504

  • Penn Community Infectious Diseases

    Philadelphia, Pennsylvania, 19107

  • Philadelphia FIGHT

    Philadelphia, Pennsylvania, 19107

  • Einstein Medical Center

    Philadelphia, Pennsylvania, 19140

  • Temple Univ School of Medicine

    Philadelphia, Pennsylvania, 19140

  • Legacy Clinic NE

    Portland, Oregon, 97209-2534

  • Salem Hospital

    Portland, Oregon, 97209-2534

  • The Research & Education Group / Multomah Cnty Hlth Dept

    Portland, Oregon, 972105311

  • The Research & Education Group / The R & E Grp Office

    Portland, Oregon, 972105311

  • The Research & Education Grp / Oregon Hlth Sci Univ

    Portland, Oregon, 972105311

  • The Rsch & Ed Grp / Legacy Cln at Good Samaritan

    Portland, Oregon, 972105311

  • The Rsch & Ed Grp / Providence Portland Med Ctr

    Portland, Oregon, 972105311

  • The Research and Education Group

    Portland, Oregon, 97210

  • Cross Over Clinic / Div of Infectious Diseases

    Richmond, Virginia, 232980049

  • McGuire VA / Division of Infectious Diseases

    Richmond, Virginia, 232980049

  • MCV ID Clinic

    Richmond, Virginia, 23298

  • MediCorp, Infectious Disease Associates

    Richmond, Virginia, 23298

  • Petersburg Health Care Alliance

    Richmond, Virginia, 23298

  • South Richmond Health Ctr

    Richmond, Virginia, 23298

  • Vernon J. Harris East End Community Health Care Ct

    Richmond, Virginia, 23298

  • Mayo Clinic/CORNET

    Rochester, Minnesota, 55905

  • William Beaumont Hospital/CORNET

    Royal Oak, Michigan, 48073

  • South Texas Veterans Health Care System

    San Antonio, Texas, 78229

  • Community Consortium / UCSF

    San Francisco, California, 94110

  • Dr. Shawn Hassler

    San Francisco, California, 94110

  • East Bay AIDS Ctr

    San Francisco, California, 94110

  • Lawrence Goldyn, MD

    San Francisco, California, 94110

  • South Jersey Infectious Disease

    Somers Poinnt, New Jersey, 08244

  • Southern Illinois University (SIU) School of Medicine

    Springfield, Illinois, 62702

  • Community Research Initiative/ProACT

    Springfield, Massachusetts, 01107

  • Bronx-Lebanon Hosp Ctr

    The Bronx, New York, 10453

  • Bronx Veterans Affairs Medical Center

    The Bronx, New York, 10468

  • Treasure Coast Infectious Disease Consultants

    Vero Beach, Florida, 32960

  • Timothy A Price

    Washington D.C., District of Columbia, 204220001

  • George Washington Univ

    Washington D.C., District of Columbia, 20422

  • Washington Reg AIDS Prog / Dept of Infect Dis

    Washington D.C., District of Columbia, 20422

  • KU Medical School-Wichita, Midtown Clinic

    Wichita, Kansas, 37214-3199

  • KU Medical School-Wichita, MPA

    Wichita, Kansas, 37214-3199

  • Christiana Care Health Services HIV Program George

    Wilmington, Delaware, 19801

  • Wake Forest Univ Health Sciences

    Winston-Salem, North Carolina, 27157-1042

Other trials in United States

United Kingdom24 sites

  • Royal Victoria Hospital

    Belfast, BT12 6BA

  • Hawthorn House, Birmingham Heartlands NHS Trust

    Birmingham, B9 5SS

  • Southmead Hospital

    Bristol, BS10 5NB

  • St. Helier Hospital

    Carshalton, SM5, 1AA

  • St. Helier Hospital

    Carshalton, Surrey, SM5, 1AA

  • Essex County Hospital

    Essex, CO3 3NB

  • Victoria General Hospital, Q.E. II Health Sciences

    Halifax

  • Homerton University Hospital NHS Foundation Trust

    London, E9 6SR

  • Barts and The London, NHS Trust

    London, EC1A 7BE

  • Central Middlesex Hospital

    London, NW10 7NS

  • Royal Free Hospital

    London, NW3 2QG

  • St. Thomas' Hospital

    London, SE1 7EH

  • T1 Coleridge Unit, North Middlesex Hospital

    London, SE5 9RS

  • The Caldecot Centre, Kings College Hospital NHS Tr

    London, SE5 9RS

  • Chelsea and Westminster Hospital

    London, SW10 9NH

  • St. George's Hospital

    London, SW17 ORE

  • St. Mary's Hospital

    London, W1 2NY

  • The Mortimer Market Center

    London, WC1E 6AU

  • The James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Pasteur Suite, Ealing Hospital

    Middlesex, UB1 3HW

  • Newcastle General Hospital

    Newcastle, NE4 6BE

  • John Radcliffe Hospital

    Oxford, England, OX3 9DU

  • Dept. of Infection and Tropical Medicine - Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • Watford Sexual Health Center;Watford General Hosp

    Watford Wd, 18 0HB

Other trials in United Kingdom

Canada13 sites

  • University de Sherbrooke

    Fleurimont, Quebec, JIH 5N4

  • The HAVEN Program, HRSRH

    Greater Sudbury, Ontario, P3E 5J1

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, NS B3H 1V7

  • Hamilton Health Science Centre-McMaster

    Hamilton, Ontario, L8N 3Z5

  • St. Joseph's Health Care Centre of London

    London, Ontario, N5Y 3H6

  • St. Josephs Hospital

    London, Ontario

  • Clinique Medicale L'actuel

    Montreal, Quebec, H2L 4P9

  • Montreal Chest Institute/Royal Victoria Hospital

    Montreal, Quebec, H2X 2P4

  • Centre hospitalier de l'universite Laval (CHUL)

    Sainte-Foy, Quebec, F1V 4G2

  • Recherche Clinique Centre Medical Halles de Saint-

    Ste-Foy, Quebec, G1V 4P9

  • Tronto General Hospital

    Toronto, Ontario, M5G 2N2

  • Downtown Infectious Disease Clinic

    Vancouver, British Columbia, V6Z 2C7

  • HIV Care Program, Windsor Regional Hospital

    Windsor, Ontario, N8W 1E3

Other trials in Canada

Brazil12 sites

  • Cassiano Antonio de Moraes University Hospital

    Boqueirao-Santos, 11045-904

  • Centro de Pesquisa Clinical do Hospital Guilherme

    Boqueirao-Santos, 11045-904

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre-RS Cep, 90035

  • Hospital Escola Sao Francisco de Asis

    Rio de Janeiro, Rio de Janeiro, 20210.030

  • Hospital dos Servidores do Estado

    Rio de Janeiro, 20221-903

  • Hospital Universitario Professor Edgard Santos

    Salvador-BA, 110-160

  • Instituto de Infectologia Emilio Ribas

    São Paulo, S.P. CEP, 01246

  • Ambulatorio de Imunodeficiencias Secundarias/Der30

    São Paulo, 01246-900

  • Universidade Federal De Sao Paulo-Hospital Sao Paulo

    São Paulo, 04040-002

  • Centro de Referencia e Treinamento DST/AIDS

    São Paulo, 04121-000

  • Unidade de Pesquisa Clinica

    São Paulo, 13083-970

Other trials in Brazil

Italy10 sites

  • U.O. Malattie Infettive, H.S.Maria Annunziata

    Antella-Firenze, 50011

  • SOCDU Malattie Infettive Ospedale Civile Asti

    Asti, 14100

  • Instituto de Malattie Infettive e Tropicali

    Brescia, I-25125

  • Malattie Infettive Busto

    Busto Arsizio (va), 21052

  • Universita degli Studi di Modena e Reggio Emilia

    Modena, 41100

  • Clinica Malattie Infettive

    Pavia, 27100

  • I.R.C.C.S."L.Spallanzani"

    Rome, 00149

  • University of Turin

    Torino, 10149

  • Servizio Regionale di Immunologia Clinica e Tipizz

    Torrette Di Ancona, 71-60020

  • S.S. Giovanni e Paolo Hospital

    Venice

Other trials in Italy

Argentina9 sites

  • Hospital de Clinicas Jose de San Martin

    Buenos Aires

  • Hospital de Infecciosas F.J. Muniz

    Buenos Aires

  • Hospital Gn'l de Agudos JM Ramos Mejia

    Buenos Aires

  • Hospital Gn'l de Agudos T. Alvarez

    Buenos Aires

  • Hospital Italiano de Buenos Aires

    Buenos Aires

  • Hospital Rawson

    Córdoba

  • Hospital Interzonall de San Juan de Dios

    La Plata

  • Hospital Central

    Mendoza

  • CAICI

    Rosario

Other trials in Argentina

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia

  • Burwood Street General Pratice

    Burwood Nsw, 2134

  • Royal Perth Hosp

    Perth

  • Alfred Hosp

    Prahan

  • Royal Prince Alfred Hospital

    Prahan

  • Prahran Market Clinic

    South Yarra, Victoria

  • The Centre Clinic

    South Yarra, Victoria

  • National Centre in HIV Epidemiology and Clinical Research

    Sydney

Other trials in Australia

France7 sites

  • CHU de la Region Annecienne

    Annecy, 74011

  • Hopital Pellegrin

    Bordeaux, 33076

  • Centre Hospitalier Universitaire

    Chu-grenoble

  • Hopital Louis Mourier

    Colombes

  • Hopital Sainte-Marguerite

    Marseille, 13009

  • Hopital Saint-Louis

    Paris, 75010

  • Hopital Pitie Salpetriere

    Paris, 75651

Other trials in France

Spain6 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, E08025

  • Hospital Universitario de La Princesa

    Madrid, E-28006

  • Hospital Universitario Principe de Asturias

    Madrid, E-28805

  • Hospital U. Virgen del Rocio

    Seville, 41013

  • Hospital Mutua de Terrassa

    Terrassa, 08221

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Switzerland5 sites

  • University Hospital Basel

    Basel Ch, 4031

  • Poliklinik fur Infektiologie

    Bern, 3010

  • Hopital de la Ville

    La Chaux-de-Fonds, 2300

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, 1011

  • Ospedale Regionale di Lugano

    Lugano, 6903

Other trials in Switzerland

Germany4 sites

  • Klinik fur Dermatologie, Venerologie, Allergologie

    Essen, 45122

  • Johann Wolfgang Goethe University Hospital

    Frankfurt am Main, 60590

  • Klinikum der Ruprecht-Karis-Universitat (U. Hospital)

    Heidelberg, D-69115

  • University Hospital Zurich

    Zurich Ch-, 8091

Other trials in Germany

Belgium2 sites

  • Institute of Tropical Medicine

    Antwerp, 2000

  • Centre Hospitalier Universitaire Sart-Tilman

    Liège, 4000

Other trials in Belgium

Japan2 sites

  • AIDS Medical Center, International Medical Center

    Tokyo, 162-8655

  • International Medical Center of Japan

    Tokyo, 162-8655

Other trials in Japan

New Zealand2 sites

  • Christchurch Hosp

    Christchurch

  • Wellington Hosp

    Wellington

Other trials in New Zealand

Peru2 sites

  • Hospital Nacional Edgardo Rebagliati Martins

    Lima, 11

  • Hospital Nacional Guillermo Almenara Irigoyen

    Lima, 13

Other trials in Peru

Thailand2 sites

  • Sanpatong Hospital

    Chiang Mai, 50120

  • Bamrasnaradura Institute

    Nonthaburi

Other trials in Thailand

Austria1 site

  • University of Vienna Medical School, AKH

    Vienna, A-1090

Other trials in Austria

Estonia1 site

  • West-Tallinn Central Hospital

    Tallinn, 10617

Other trials in Estonia

Ireland1 site

  • St. James Hospital

    Dublin

Other trials in Ireland

Israel1 site

  • Ramathibodi Hospital

    Tel Aviv, 64239

Other trials in Israel

Lithuania1 site

  • Lithuanian AIDS center

    Vilnius, 03011

Other trials in Lithuania

Luxembourg1 site

  • Centre Hospitalier de Luxembourg

    Barble, L-1210

Other trials in Luxembourg

Martinique1 site

  • C.H.U. Fort-de-France

    Fort-de-France, 97261

Other trials in Martinique

Norway1 site

  • Ulleval Hospital

    Oslo, N-0407

Other trials in Norway

Poland1 site

  • Wroclaw University School of Medicine

    Koszarowa Str. 5

Other trials in Poland

Puerto Rico1 site

  • Instituto A. Z. de Pesquisa e Ensino

    Curitiba, 80430-040

Other trials in Puerto Rico

About this study

Official title: A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)

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.

Read the detailed description

Implementation of antiretroviral treatment (ART) guidelines, which emphasize maximal and durable suppression of viral load for the majority of individuals infected with HIV, has resulted in a substantial decline in morbidity and mortality. However, many asymptomatic patients are not at immediate risk of serious opportunistic diseases, the effectiveness of ART wanes over time due to HIV drug resistance, and there are short- and long-term toxicities of treatment. This motivates a comparison of two strategies: one which conserves treatments by deferring their use while the risk of opportunistic disease is low and one which aims for sustained virologic suppression, irrespective of disease risk.

In this large, long-term trial, patients will be randomly assigned to either the drug conservation (DC) or viral suppression (VS) group. Patients will be enrolled over a 3-year period and followed for an average of 7.5 years. The DC group will stop or defer ART until CD4 cell count declines to below 250 cells/mm3; they will then receive treatment to increase CD4 count to greater than 350 cells/mm3 followed by episodic ART based on CD4 cell count. The VS group will use ART to maintain viral load as low as possible, irrespective of CD4 cell count. Patients will be seen Months 1, 2, 4, 6, 8, 10, and 12, then every 4 months for data collection visits. All available ARTs, including immunomodulators, and resistance testing may be used by patients in both treatment groups. Selected subsamples of patients enrolled in the study will be followed with more intensive data collection for secondary outcomes relating to cost and health care utilization, quality of life, HIV transmission risk behaviors, and metabolic complications of treatment.

Conditions
HIV Infections
Keywords
Physician's Practice Patterns, Anti-HIV Agents
Medical subject headings
HIV Infections

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2001 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
6,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00027352
Sponsor's protocol ID
CPCRA 065
Other IDs
SMART
Status last verified
Dec 2008
First submitted
4 Dec 2001
Last updated
25 Nov 2009
Results posted
No

Publications

  • 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.

    PubMed 10889597

  • Carpenter 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.

    PubMed 10647802

  • Mocroft 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.

    PubMed 11071184

  • Tebas 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.

    PubMed 12198623

  • Yerly 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.

    PubMed 10716500

  • Borges 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.

    PubMed 30032171

  • Castillo-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.

    PubMed 29362724

  • Larson 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.

    PubMed 26908541

  • Nordell 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.

    PubMed 24870935

  • Lucas 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.

    PubMed 24024499

  • Baker 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.

    PubMed 23896681

  • Hoy 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.

    PubMed 23299909

  • Zetterberg 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.

    PubMed 23018440

  • Mocroft 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.

    PubMed 22911697

  • Baker 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.

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Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 223 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 223 sites in United States, United Kingdom, Canada, Brazil, Italy and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00027352, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2009.

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Clinical Trial NCT00027352 | AzTrials