A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)
- Conditions
- HIV Infections
- Registration Number
- NCT00027352
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (222)
Unidade de Pesquisa Clinica
🇧🇷San Paulo, Brazil
CHU de la Region Annecienne
🇫🇷Annecy, France
Timothy A Price
🇺🇸Washington, District of Columbia, United States
Centre Hospitalier Universitaire
🇫🇷Chu-grenoble, France
Hopital Louis Mourier
🇫🇷Colombes, France
Treasure Coast Infectious Disease Consultants
🇺🇸Vero Beach, Florida, United States
George Washington Univ
🇺🇸Washington, District of Columbia, United States
Hospital de Clinicas Jose de San Martin
🇦🇷Buenos Aires, Argentina
Burwood Street General Pratice
🇦🇺Burwood Nsw, Australia
Center for Prevention and Treatment of Infections
🇺🇸Pensacola, Florida, United States
Hospital Interzonall de San Juan de Dios
🇦🇷La Plata, Argentina
Ambulatorio de Imunodeficiencias Secundarias/Der30
🇧🇷Sao Paulo, Brazil
Cooper Hospital Early Intervention Program
🇺🇸Camden, New Jersey, United States
Hospital Rawson
🇦🇷Cordoba, Argentina
Hopital Sainte-Marguerite
🇫🇷Marseille, France
Hospital Gn'l de Agudos JM Ramos Mejia
🇦🇷Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
St. James Hospital
🇮🇪Dublin 8, Ireland
Alfred Hosp
🇦🇺Prahan, Australia
Royal Perth Hosp
🇦🇺Perth, Australia
University Hospital Zurich
🇩🇪Zurich Ch-, Germany
Hospital de Infecciosas F.J. Muniz
🇦🇷Buenos Aires, Argentina
Hospital Gn'l de Agudos T. Alvarez
🇦🇷Buenos Aires, Argentina
Hospital Central
🇦🇷Mendoza, Argentina
Institute of Tropical Medicine
🇧🇪Antwerp, Belgium
The Caldecot Centre, Kings College Hospital NHS Tr
🇬🇧London, United Kingdom
Hopital Pellegrin
🇫🇷Bordeaux, France
Johann Wolfgang Goethe University Hospital
🇩🇪Frankfort, Germany
Wellington Hosp
🇳🇿Wellington, New Zealand
Downtown Infectious Disease Clinic
🇨🇦Vancouver, British Columbia, Canada
West-Tallinn Central Hospital
🇪🇪Tallinn, Estonia
International Medical Center of Japan
🇯🇵Tokyo, Japan
Hopital Pitie Salpetriere
🇫🇷Paris, France
Central Middlesex Hospital
🇬🇧London, United Kingdom
St. Thomas' Hospital
🇬🇧London, United Kingdom
Christchurch Hosp
🇳🇿Christchurch, New Zealand
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
Klinik fur Dermatologie, Venerologie, Allergologie
🇩🇪Essen, Germany
Hospital Mutua de Terrassa
🇪🇸Terrassa, Spain
Hospital Universitario Principe de Asturias
🇪🇸Madrid, Spain
Hawthorn House, Birmingham Heartlands NHS Trust
🇬🇧Birmingham, United Kingdom
St. Helier Hospital
🇬🇧Carshalton, United Kingdom
Hopital Saint-Louis
🇫🇷Paris, France
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Klinikum der Ruprecht-Karis-Universitat (U. Hospital)
🇩🇪Heidelberg, Germany
Lithuanian AIDS center
🇱🇹Vilnius, Lithuania
Hopital de la Ville
🇨ðŸ‡La Chaux-de-Fonds, Switzerland
The Mortimer Market Center
🇬🇧London, United Kingdom
Consorcio Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital U. Virgen del Rocio
🇪🇸Sevilla, Spain
Homerton University Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Hospital Nacional Guillermo Almenara Irigoyen
🇵🇪Lima, Peru
Bamrasnaradura Institute
🇹ðŸ‡Nonthaburi 11000, Thailand
Newcastle General Hospital
🇬🇧Newcastle, United Kingdom
Dept. of Infection and Tropical Medicine - Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Los Angeles Gay and Lesbian Community Service Ctr
🇺🇸Los Angeles, California, United States
Miami Veterans Affairs Med Ctr
🇺🇸Miami, Florida, United States
Absolute Care Clinic
🇺🇸Atlanta, Georgia, United States
AID Atlanta/Morehouse Med School Ryan White Cl
🇺🇸Atlanta, Georgia, United States
Dekalb County Health Dept Infectious Disease
🇺🇸Atlanta, Georgia, United States
Dr. Dennis Melton (Private Practice)
🇺🇸Atlanta, Georgia, United States
Dr. Richard Hudson (Private Practice)
🇺🇸Atlanta, Georgia, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Klein and Slotten Associates / AIDS Research Alliance
🇺🇸Chicago, Illinois, United States
Lakeshore Infectious Disease Associates
🇺🇸Chicago, Illinois, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Northwestern Memorial Physicians
🇺🇸Chicago, Illinois, United States
Community Research Initiatives of New England
🇺🇸Boston, Massachusetts, United States
Community Research Initiatives/ProACT
🇺🇸Boston, Massachusetts, United States
Michigan State University Infectious Diseases Clinic
🇺🇸Lansing, Michigan, United States
Penn Community Infectious Diseases
🇺🇸Philadelphia, Pennsylvania, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Temple Univ School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
University Clinical Research Center
🇺🇸Houston, Texas, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Community Consortium / UCSF
🇺🇸San Francisco, California, United States
Dr. Shawn Hassler
🇺🇸San Francisco, California, United States
East Bay AIDS Ctr
🇺🇸San Francisco, California, United States
Lawrence Goldyn, MD
🇺🇸San Francisco, California, United States
South Texas Veterans Health Care System
🇺🇸San Antonio, Texas, United States
KU Medical School-Wichita, Midtown Clinic
🇺🇸Wichita, Kansas, United States
KU Medical School-Wichita, MPA
🇺🇸Wichita, Kansas, United States
Ramathibodi Hospital
🇮🇱Tel Aviv, Israel
Drs. Lichtenstein & Greenberg
🇺🇸Denver, Colorado, United States
Western Infectious Disease Consultants
🇺🇸Denver, Colorado, United States
Denver CPCRA / Denver Public Hlth
🇺🇸Denver, Colorado, United States
McDowell Healthcare Center
🇺🇸Denver, Colorado, United States
Wayne State Univ / Medical College of Ohio at Toledo
🇺🇸Detroit, Michigan, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Providence Hosp- Newland Med Assoc. Inc.
🇺🇸Detroit, Michigan, United States
Univ of Oklahoma Health Sciences
🇺🇸Oklahoma City, Oklahoma, United States
Legacy Clinic NE
🇺🇸Portland, Oregon, United States
The Research & Education Group / Multomah Cnty Hlth Dept
🇺🇸Portland, Oregon, United States
The Research & Education Group / The R & E Grp Office
🇺🇸Portland, Oregon, United States
The Research & Education Grp / Oregon Hlth Sci Univ
🇺🇸Portland, Oregon, United States
The Research and Education Group
🇺🇸Portland, Oregon, United States
U.O. Malattie Infettive, H.S.Maria Annunziata
🇮🇹Antella-Firenze, Italy
SOCDU Malattie Infettive Ospedale Civile Asti
🇮🇹Asti, Italy
Instituto de Malattie Infettive e Tropicali
🇮🇹Brescia, Italy
Malattie Infettive Busto
🇮🇹Busto Arsizio (va), Italy
Universita degli Studi di Modena e Reggio Emilia
🇮🇹Modena, Italy
Clinica Malattie Infettive
🇮🇹Pavia, Italy
I.R.C.C.S."L.Spallanzani"
🇮🇹Rome, Italy
University of Turin
🇮🇹Torino, Italy
Servizio Regionale di Immunologia Clinica e Tipizz
🇮🇹Torrette Di Ancona, Italy
S.S. Giovanni e Paolo Hospital
🇮🇹Venice, Italy
Southmead Hospital
🇬🇧Bristol, United Kingdom
Essex County Hospital
🇬🇧Essex, United Kingdom
Victoria General Hospital, Q.E. II Health Sciences
🇬🇧Halifax, United Kingdom
Barts and The London, NHS Trust
🇬🇧London, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
T1 Coleridge Unit, North Middlesex Hospital
🇬🇧London, United Kingdom
Chelsea and Westminster Hospital
🇬🇧London, United Kingdom
St. Mary's Hospital
🇬🇧London, United Kingdom
The James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
Pasteur Suite, Ealing Hospital
🇬🇧Middlesex, United Kingdom
Watford Sexual Health Center;Watford General Hosp
🇬🇧Watford Wd, United Kingdom
Universidade Federal De Sao Paulo-Hospital Sao Paulo
🇧🇷Sao Paulo, Brazil
Jacobi Medical Center
🇺🇸New York, New York, United States
Polo Grounds Health Care Ctr
🇺🇸New York, New York, United States
AIDS Research Consortium of Atlanta (ARCA) Central
🇺🇸Atlanta, Georgia, United States
Dr. Melanie Thompson and Dr. Annette Bernard (Private Practice)
🇺🇸Atlanta, Georgia, United States
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
Northside Family Medicine
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Southern Illinois University (SIU) School of Medicine
🇺🇸Springfield, Illinois, United States
Detroit Community Health Connection
🇺🇸Detroit, Michigan, United States
Detroit Receiving
🇺🇸Detroit, Michigan, United States
Mt. Clemens General Hospital
🇺🇸Detroit, Michigan, United States
William Beaumont Hospital/CORNET
🇺🇸Royal Oak, Michigan, United States
Salem Hospital
🇺🇸Portland, Oregon, United States
Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Montrose Clinic
🇺🇸Houston, Texas, United States
Houston Veterans Administration Med Ctr
🇺🇸Houston, Texas, United States
Univ TX Health Science Ctr
🇺🇸Houston, Texas, United States
Infectious Disease Associates of Virginia
🇺🇸Lynchburg, Virginia, United States
Community Research Initiative/ProACT
🇺🇸Springfield, Massachusetts, United States
The Rsch & Ed Grp / Legacy Cln at Good Samaritan
🇺🇸Portland, Oregon, United States
The Rsch & Ed Grp / Providence Portland Med Ctr
🇺🇸Portland, Oregon, United States
Royal Prince Alfred Hospital
🇦🇺Prahan, Australia
Kaiser Permanente-Fremont/Hayward Medical Centers
🇺🇸Fremont, California, United States
Cobb-Douglas County Infectious Disease Clinic
🇺🇸Atlanta, Georgia, United States
McAuley Health Center
🇺🇸Grand Rapids, Michigan, United States
Saint Michael's Med Ctr
🇺🇸Newark, New Jersey, United States
Raritan Bay Med Ctr
🇺🇸Newark, New Jersey, United States
Jeffrey Bomser Clinic / NJCR
🇺🇸Newark, New Jersey, United States
South Jersey Infectious Disease
🇺🇸Somers Poinnt, New Jersey, United States
NJCRI
🇺🇸Newark, New Jersey, United States
SUNY Downstate Med Ctr
🇺🇸Brooklyn, New York, United States
Grant Houses Health Ctr
🇺🇸New York, New York, United States
HHC Outpatient Clinics
🇺🇸New York, New York, United States
HHC MMC Unit #1
🇺🇸New York, New York, United States
Lenox Avenue Health Ctr
🇺🇸New York, New York, United States
Lincoln Medical & Mental Health Center
🇺🇸New York, New York, United States
Metropolitan Hospital Center
🇺🇸New York, New York, United States
Syndenham Neighborhood Family Care Ctr
🇺🇸New York, New York, United States
Instituto de Infectologia Emilio Ribas
🇧🇷Sao Paulo, S.p. Cep, Brazil
National Centre in HIV Epidemiology and Clinical Research
🇦🇺Sydney, Australia
Centre Hospitalier Universitaire Sart-Tilman
🇧🇪Liege, Belgium
Hospital Nossa Senhora da Conceicao
🇧🇷Porto Alegre, RS, Brazil
Hospital Escola Sao Francisco de Asis
🇧🇷Rio de Janeiro, RJ, Brazil
University of Vienna Medical School, AKH
🇦🇹Vienna, Austria
Centro de Referencia e Treinamento DST/AIDS
🇧🇷San Paulo, Brazil
Hospital dos Servidores do Estado
🇧🇷Rio de Janeiro, Brazil
Cassiano Antonio de Moraes University Hospital
🇧🇷Boqueirao-Santos, Brazil
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre-RS Cep, Brazil
Centro de Pesquisa Clinical do Hospital Guilherme
🇧🇷Boqueirao-Santos, Brazil
Hospital Universitario Professor Edgard Santos
🇧🇷Salvador-BA, Brazil
Hamilton Health Science Centre-McMaster
🇨🇦Hamilton, Ontario, Canada
Tronto General Hospital
🇨🇦Toronto, Ontario, Canada
St. Josephs Hospital
🇨🇦London, Ontario, Canada
Recherche Clinique Centre Medical Halles de Saint-
🇨🇦Ste-Foy, Quebec, Canada
St. Joseph's Health Care Centre of London
🇨🇦London, Ontario, Canada
The HAVEN Program, HRSRH
🇨🇦Sudbury, Ontario, Canada
HIV Care Program, Windsor Regional Hospital
🇨🇦Windsor, Ontario, Canada
Clinique Medicale L'actuel
🇨🇦Montreal, Quebec, Canada
Montreal Chest Institute/Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
St. George's Hospital
🇬🇧London, United Kingdom
CAICI
🇦🇷Rosario, Argentina
Jersey Shore Med Ctr
🇺🇸Neptune, New Jersey, United States
HIV Services Clinic/Family Practice Medical Center
🇺🇸Boise, Idaho, United States
C.H.U. Fort-de-France
🇲🇶Fort-de-france, Martinique
Wroclaw University School of Medicine
🇵🇱Koszarowa Str. 5, Poland
Instituto A. Z. de Pesquisa e Ensino
🇵🇷Curitiba, Puerto Rico
Ospedale Regionale di Lugano
🇨ðŸ‡Lugano, Switzerland
Christiana Care Health Services HIV Program George
🇺🇸Wilmington, Delaware, United States
Prahran Market Clinic
🇦🇺South Yarra, Victoria, Australia
University de Sherbrooke
🇨🇦Fleurimont, Quebec, Canada
Centre hospitalier de l'universite Laval (CHUL)
🇨🇦Sainte-Foy, Quebec, Canada
Poliklinik fur Infektiologie
🇨ðŸ‡Bern, Switzerland
Sanpatong Hospital
🇹ðŸ‡Chiang Mai, Thailand
University Hospital Basel
🇨ðŸ‡Basel Ch, Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV)
🇨ðŸ‡Lausanne, Switzerland
The Centre Clinic
🇦🇺South Yarra, Victoria, Australia
AIDS Medical Center, International Medical Center
🇯🇵Tokyo, Japan
Centre Hospitalier de Luxembourg
🇱🇺Barble, Luxembourg
Ulleval Hospital
🇳🇴Oslo, Norway
Hospital Nacional Edgardo Rebagliati Martins
🇵🇪Lima, Peru
New Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
🇺🇸New Haven, Connecticut, United States
Veterans Administration Medical Center
🇺🇸New Haven, Connecticut, United States
University of Mississippi Medical Center
🇺🇸New Orleans, Louisiana, United States
Our Lady of the Lake Regional Med Ctr
🇺🇸New Orleans, Louisiana, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
🇺🇸New Orleans, Louisiana, United States
Mayo Clinic/CORNET
🇺🇸Rochester, Minnesota, United States
Bronx-Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Bronx Veterans Affairs Medical Center
🇺🇸Bronx, New York, United States
Wake Forest Univ Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Cross Over Clinic / Div of Infectious Diseases
🇺🇸Richmond, Virginia, United States
McGuire VA / Division of Infectious Diseases
🇺🇸Richmond, Virginia, United States
MCV ID Clinic
🇺🇸Richmond, Virginia, United States
MediCorp, Infectious Disease Associates
🇺🇸Richmond, Virginia, United States
Petersburg Health Care Alliance
🇺🇸Richmond, Virginia, United States
South Richmond Health Ctr
🇺🇸Richmond, Virginia, United States
Vernon J. Harris East End Community Health Care Ct
🇺🇸Richmond, Virginia, United States
University Of Wisconsin Hospital and Clinics/CORNET, HIV Care Program
🇺🇸Madison, Wisconsin, United States
Washington Reg AIDS Prog / Dept of Infect Dis
🇺🇸Washington, District of Columbia, United States
AIDS Healthcare Foundation
🇺🇸Los Angeles, California, United States
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada