Clinical trial NCT00027352: A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)
Official title: A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Physician's Practice Patterns
Anti-HIV Agents
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-12-05
Enrollment: 6000
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

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.

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.

Eligibility criteria: Note: Enrollment into this trial was halted 01/11/06.

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Kaiser Permanente-Fremont/Hayward Medical Centers
state: California
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
city: Los Angeles
country: United States
facility: Los Angeles Gay and Lesbian Community Service Ctr
state: California
city: San Francisco
country: United States
facility: Community Consortium / UCSF
state: California
city: San Francisco
country: United States
facility: Dr. Shawn Hassler
state: California
city: San Francisco
country: United States
facility: East Bay AIDS Ctr
state: California
city: San Francisco
country: United States
facility: Lawrence Goldyn, MD
state: California
city: Denver
country: United States
facility: Drs. Lichtenstein & Greenberg
state: Colorado
city: Denver
country: United States
facility: Western Infectious Disease Consultants
state: Colorado
city: Denver
country: United States
facility: Denver CPCRA / Denver Public Hlth
state: Colorado
city: Denver
country: United States
facility: McDowell Healthcare Center
state: Colorado
city: New Haven
country: United States
facility: Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
state: Connecticut
city: New Haven
country: United States
facility: Veterans Administration Medical Center
state: Connecticut
city: Wilmington
country: United States
facility: Christiana Care Health Services HIV Program George
state: Delaware
city: Washington
country: United States
facility: Timothy A Price
state: District of Columbia
city: Washington
country: United States
facility: George Washington Univ
state: District of Columbia
city: Washington
country: United States
facility: Washington Reg AIDS Prog / Dept of Infect Dis
state: District of Columbia
city: Miami
country: United States
facility: Miami Veterans Affairs Med Ctr
state: Florida
city: Pensacola
country: United States
facility: Center for Prevention and Treatment of Infections
state: Florida
city: Vero Beach
country: United States
facility: Treasure Coast Infectious Disease Consultants
state: Florida
city: Atlanta
country: United States
facility: Absolute Care Clinic
state: Georgia
city: Atlanta
country: United States
facility: AID Atlanta/Morehouse Med School Ryan White Cl
state: Georgia
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta (ARCA) Central
state: Georgia
city: Atlanta
country: United States
facility: Cobb-Douglas County Infectious Disease Clinic
state: Georgia
city: Atlanta
country: United States
facility: Dekalb County Health Dept Infectious Disease
state: Georgia
city: Atlanta
country: United States
facility: Dr. Dennis Melton (Private Practice)
state: Georgia
city: Atlanta
country: United States
facility: Dr. Melanie Thompson and Dr. Annette Bernard (Private Practice)
state: Georgia
city: Atlanta
country: United States
facility: Dr. Richard Hudson (Private Practice)
state: Georgia
city: Boise
country: United States
facility: HIV Services Clinic/Family Practice Medical Center
state: Idaho
city: Chicago
country: United States
facility: Cook County Hosp
state: Illinois
city: Chicago
country: United States
facility: Klein and Slotten Associates / AIDS Research Alliance
state: Illinois
city: Chicago
country: United States
facility: Lakeshore Infectious Disease Associates
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: AIDS Research Alliance - Chicago
state: Illinois
city: Chicago
country: United States
facility: Northside Family Medicine
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Physicians
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University (SIU) School of Medicine
state: Illinois
city: Wichita
country: United States
facility: KU Medical School-Wichita, Midtown Clinic
state: Kansas
city: Wichita
country: United States
facility: KU Medical School-Wichita, MPA
state: Kansas
city: New Orleans
country: United States
facility: University of Mississippi Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Our Lady of the Lake Regional Med Ctr
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
state: Louisiana
city: Boston
country: United States
facility: Community Research Initiatives of New England
state: Massachusetts
city: Boston
country: United States
facility: Community Research Initiatives/ProACT
state: Massachusetts
city: Springfield
country: United States
facility: Community Research Initiative/ProACT
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Detroit Community Health Connection
state: Michigan
city: Detroit
country: United States
facility: Detroit Receiving
state: Michigan
city: Detroit
country: United States
facility: Wayne State Univ / Medical College of Ohio at Toledo
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hosp
state: Michigan
city: Detroit
country: United States
facility: Mt. Clemens General Hospital
state: Michigan
city: Detroit
country: United States
facility: Providence Hosp- Newland Med Assoc. Inc.
state: Michigan
city: Grand Rapids
country: United States
facility: McAuley Health Center
state: Michigan
city: Lansing
country: United States
facility: Michigan State University Infectious Diseases Clinic
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital/CORNET
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic/CORNET
state: Minnesota
city: Camden
country: United States
facility: Cooper Hospital Early Intervention Program
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore Med Ctr
state: New Jersey
city: Newark
country: United States
facility: Raritan Bay Med Ctr
state: New Jersey
city: Newark
country: United States
facility: Saint Michael's Med Ctr
state: New Jersey
city: Newark
country: United States
facility: Jeffrey Bomser Clinic / NJCR
state: New Jersey
city: Newark
country: United States
facility: New Jersey Community Research Initiative
state: New Jersey
city: Newark
country: United States
facility: NJCRI
state: New Jersey
city: Somers Poinnt
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: Bronx
country: United States
facility: Bronx-Lebanon Hosp Ctr
state: New York
city: Bronx
country: United States
facility: Bronx Veterans Affairs Medical Center
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Med Ctr
state: New York
city: New York
country: United States
facility: Grant Houses Health Ctr
state: New York
city: New York
country: United States
facility: HHC MMC Unit #1
state: New York
city: New York
country: United States
facility: HHC Outpatient Clinics
state: New York
city: New York
country: United States
facility: Jacobi Medical Center
state: New York
city: New York
country: United States
facility: Lenox Avenue Health Ctr
state: New York
city: New York
country: United States
facility: Lincoln Medical & Mental Health Center
state: New York
city: New York
country: United States
facility: Polo Grounds Health Care Ctr
state: New York
city: New York
country: United States
facility: Syndenham Neighborhood Family Care Ctr
state: New York
city: New York
country: United States
facility: Metropolitan Hospital Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Univ Health Sciences
state: North Carolina
city: Oklahoma City
country: United States
facility: Univ of Oklahoma Health Sciences
state: Oklahoma
city: Portland
country: United States
facility: Legacy Clinic NE
state: Oregon
city: Portland
country: United States
facility: Salem Hospital
state: Oregon
city: Portland
country: United States
facility: The Research & Education Group / Multomah Cnty Hlth Dept
state: Oregon
city: Portland
country: United States
facility: The Research & Education Group / The R & E Grp Office
state: Oregon
city: Portland
country: United States
facility: The Research & Education Grp / Oregon Hlth Sci Univ
state: Oregon
city: Portland
country: United States
facility: The Rsch & Ed Grp / Legacy Cln at Good Samaritan
state: Oregon
city: Portland
country: United States
facility: The Rsch & Ed Grp / Providence Portland Med Ctr
state: Oregon
city: Portland
country: United States
facility: The Research and Education Group
state: Oregon
city: Philadelphia
country: United States
facility: Penn Community Infectious Diseases
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple Univ School of Medicine
state: Pennsylvania
city: Houston
country: United States
facility: Montrose Clinic
state: Texas
city: Houston
country: United States
facility: Houston Veterans Administration Med Ctr
state: Texas
city: Houston
country: United States
facility: Univ TX Health Science Ctr
state: Texas
city: Houston
country: United States
facility: University Clinical Research Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Veterans Health Care System
state: Texas
city: Lynchburg
country: United States
facility: Infectious Disease Associates of Virginia
state: Virginia
city: Richmond
country: United States
facility: Cross Over Clinic / Div of Infectious Diseases
state: Virginia
city: Richmond
country: United States
facility: McGuire VA / Division of Infectious Diseases
state: Virginia
city: Richmond
country: United States
facility: MCV ID Clinic
state: Virginia
city: Richmond
country: United States
facility: MediCorp, Infectious Disease Associates
state: Virginia
city: Richmond
country: United States
facility: Petersburg Health Care Alliance
state: Virginia
city: Richmond
country: United States
facility: South Richmond Health Ctr
state: Virginia
city: Richmond
country: United States
facility: Vernon J. Harris East End Community Health Care Ct
state: Virginia
city: Madison
country: United States
facility: University Of Wisconsin Hospital and Clinics/CORNET, HIV Care Program
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Hospital de Clinicas Jose de San Martin
city: Buenos Aires
country: Argentina
facility: Hospital de Infecciosas F.J. Muniz
city: Buenos Aires
country: Argentina
facility: Hospital Gn'l de Agudos JM Ramos Mejia
city: Buenos Aires
country: Argentina
facility: Hospital Gn'l de Agudos T. Alvarez
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Cordoba
country: Argentina
facility: Hospital Rawson
city: La Plata
country: Argentina
facility: Hospital Interzonall de San Juan de Dios
city: Mendoza
country: Argentina
facility: Hospital Central
city: Rosario
country: Argentina
facility: CAICI
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: South Yarra
country: Australia
facility: Prahran Market Clinic
state: Victoria
city: South Yarra
country: Australia
facility: The Centre Clinic
state: Victoria
city: Burwood Nsw
country: Australia
facility: Burwood Street General Pratice
city: Perth
country: Australia
facility: Royal Perth Hosp
city: Prahan
country: Australia
facility: Alfred Hosp
city: Prahan
country: Australia
facility: Royal Prince Alfred Hospital
city: Sydney
country: Australia
facility: National Centre in HIV Epidemiology and Clinical Research
city: Vienna
country: Austria
facility: University of Vienna Medical School, AKH
city: Antwerp
country: Belgium
facility: Institute of Tropical Medicine
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire Sart-Tilman
city: Rio de Janeiro
country: Brazil
facility: Hospital Escola Sao Francisco de Asis
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: RS
city: Sao Paulo
country: Brazil
facility: Instituto de Infectologia Emilio Ribas
state: S.p. Cep
city: Boqueirao-Santos
country: Brazil
facility: Cassiano Antonio de Moraes University Hospital
city: Boqueirao-Santos
country: Brazil
facility: Centro de Pesquisa Clinical do Hospital Guilherme
city: Porto Alegre-RS Cep
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Hospital dos Servidores do Estado
city: Salvador-BA
country: Brazil
facility: Hospital Universitario Professor Edgard Santos
city: San Paulo
country: Brazil
facility: Centro de Referencia e Treinamento DST/AIDS
city: San Paulo
country: Brazil
facility: Unidade de Pesquisa Clinica
city: Sao Paulo
country: Brazil
facility: Ambulatorio de Imunodeficiencias Secundarias/Der30
city: Sao Paulo
country: Brazil
facility: Universidade Federal De Sao Paulo-Hospital Sao Paulo
city: Vancouver
country: Canada
facility: Downtown Infectious Disease Clinic
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Science Centre-McMaster
state: Ontario
city: London
country: Canada
facility: St. Joseph's Health Care Centre of London
state: Ontario
city: London
country: Canada
facility: St. Josephs Hospital
state: Ontario
city: Sudbury
country: Canada
facility: The HAVEN Program, HRSRH
state: Ontario
city: Toronto
country: Canada
facility: Tronto General Hospital
state: Ontario
city: Windsor
country: Canada
facility: HIV Care Program, Windsor Regional Hospital
state: Ontario
city: Fleurimont
country: Canada
facility: University de Sherbrooke
state: Quebec
city: Montreal
country: Canada
facility: Clinique Medicale L'actuel
state: Quebec
city: Montreal
country: Canada
facility: Montreal Chest Institute/Royal Victoria Hospital
state: Quebec
city: Sainte-Foy
country: Canada
facility: Centre hospitalier de l'universite Laval (CHUL)
state: Quebec
city: Ste-Foy
country: Canada
facility: Recherche Clinique Centre Medical Halles de Saint-
state: Quebec
city: Tallinn
country: Estonia
facility: West-Tallinn Central Hospital
city: Annecy
country: France
facility: CHU de la Region Annecienne
city: Bordeaux
country: France
facility: Hopital Pellegrin
city: Chu-grenoble
country: France
facility: Centre Hospitalier Universitaire
city: Colombes
country: France
facility: Hopital Louis Mourier
city: Marseille
country: France
facility: Hopital Sainte-Marguerite
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Essen
country: Germany
facility: Klinik fur Dermatologie, Venerologie, Allergologie
city: Frankfort
country: Germany
facility: Johann Wolfgang Goethe University Hospital
city: Heidelberg
country: Germany
facility: Klinikum der Ruprecht-Karis-Universitat (U. Hospital)
city: Zurich Ch-
country: Germany
facility: University Hospital Zurich
city: Dublin 8
country: Ireland
facility: St. James Hospital
city: Tel Aviv
country: Israel
facility: Ramathibodi Hospital
city: Antella-Firenze
country: Italy
facility: U.O. Malattie Infettive, H.S.Maria Annunziata
city: Asti
country: Italy
facility: SOCDU Malattie Infettive Ospedale Civile Asti
city: Brescia
country: Italy
facility: Instituto de Malattie Infettive e Tropicali
city: Busto Arsizio (va)
country: Italy
facility: Malattie Infettive Busto
city: Modena
country: Italy
facility: Universita degli Studi di Modena e Reggio Emilia
city: Pavia
country: Italy
facility: Clinica Malattie Infettive
city: Rome
country: Italy
facility: I.R.C.C.S."L.Spallanzani"
city: Torino
country: Italy
facility: University of Turin
city: Torrette Di Ancona
country: Italy
facility: Servizio Regionale di Immunologia Clinica e Tipizz
city: Venice
country: Italy
facility: S.S. Giovanni e Paolo Hospital
city: Tokyo
country: Japan
facility: AIDS Medical Center, International Medical Center
city: Tokyo
country: Japan
facility: International Medical Center of Japan
city: Vilnius
country: Lithuania
facility: Lithuanian AIDS center
city: Barble
country: Luxembourg
facility: Centre Hospitalier de Luxembourg
city: Fort-de-france
country: Martinique
facility: C.H.U. Fort-de-France
city: Christchurch
country: New Zealand
facility: Christchurch Hosp
city: Wellington
country: New Zealand
facility: Wellington Hosp
city: Oslo
country: Norway
facility: Ulleval Hospital
city: Lima
country: Peru
facility: Hospital Nacional Edgardo Rebagliati Martins
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen
city: Koszarowa Str. 5
country: Poland
facility: Wroclaw University School of Medicine
city: Curitiba
country: Puerto Rico
facility: Instituto A. Z. de Pesquisa e Ensino
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Principe de Asturias
city: Sevilla
country: Spain
facility: Hospital U. Virgen del Rocio
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Basel Ch
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: Poliklinik fur Infektiologie
city: La Chaux-de-Fonds
country: Switzerland
facility: Hopital de la Ville
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (CHUV)
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
city: Chiang Mai
country: Thailand
facility: Sanpatong Hospital
city: Nonthaburi 11000
country: Thailand
facility: Bamrasnaradura Institute
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: England
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Birmingham
country: United Kingdom
facility: Hawthorn House, Birmingham Heartlands NHS Trust
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Carshalton, Surrey
country: United Kingdom
facility: St. Helier Hospital
city: Carshalton
country: United Kingdom
facility: St. Helier Hospital
city: Essex
country: United Kingdom
facility: Essex County Hospital
city: Halifax
country: United Kingdom
facility: Victoria General Hospital, Q.E. II Health Sciences
city: London
country: United Kingdom
facility: Homerton University Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Barts and The London, NHS Trust
city: London
country: United Kingdom
facility: Central Middlesex Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: St. Thomas' Hospital
city: London
country: United Kingdom
facility: T1 Coleridge Unit, North Middlesex Hospital
city: London
country: United Kingdom
facility: The Caldecot Centre, Kings College Hospital NHS Tr
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: St. George's Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital
city: London
country: United Kingdom
facility: The Mortimer Market Center
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
city: Middlesex
country: United Kingdom
facility: Pasteur Suite, Ealing Hospital
city: Newcastle
country: United Kingdom
facility: Newcastle General Hospital
city: Sheffield
country: United Kingdom
facility: Dept. of Infection and Tropical Medicine - Royal Hallamshire Hospital
city: Watford Wd
country: United Kingdom
facility: Watford Sexual Health Center;Watford General Hosp
Study officials:
affiliation: Harlem AIDS Treatment Group, Harlem Hospital Center
name: Wafaa El-Sadr, MD, MPH
role: STUDY_CHAIR
affiliation: CPCRA Statistcal and Data Management Center / CCBR
name: James Neaton, PhD
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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