Trial record 1 of 1 for:    NCT00027352
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A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00027352
First received: December 4, 2001
Last updated: November 24, 2009
Last verified: December 2008
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 6000
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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027352

  Hide Study Locations
Locations
United States, California
Kaiser Permanente-Fremont/Hayward Medical Centers
Fremont, California, United States, 94538
AIDS Healthcare Foundation
Los Angeles, California, United States, 90015
Los Angeles Gay and Lesbian Community Service Ctr
Los Angeles, California, United States, 90028
Lawrence Goldyn, MD
San Francisco, California, United States, 94110
Community Consortium / UCSF
San Francisco, California, United States, 94110
East Bay AIDS Ctr
San Francisco, California, United States, 94110
Dr. Shawn Hassler
San Francisco, California, United States, 94110
United States, Colorado
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 802044507
Western Infectious Disease Consultants
Denver, Colorado, United States, 80204-4507
McDowell Healthcare Center
Denver, Colorado, United States, 80204
Drs. Lichtenstein & Greenberg
Denver, Colorado, United States, 80204-4507
United States, Connecticut
Veterans Administration Medical Center
New Haven, Connecticut, United States, 06510
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
New Haven, Connecticut, United States, 065102483
United States, Delaware
Christiana Care Health Services HIV Program George
Wilmington, Delaware, United States, 19801
United States, District of Columbia
George Washington Univ
Washington, District of Columbia, United States, 20422
Timothy A Price
Washington, District of Columbia, United States, 204220001
Washington Reg AIDS Prog / Dept of Infect Dis
Washington, District of Columbia, United States, 20422
United States, Florida
Miami Veterans Affairs Med Ctr
Miami, Florida, United States, 33125
Center for Prevention and Treatment of Infections
Pensacola, Florida, United States, 32504
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
United States, Georgia
Dr. Melanie Thompson and Dr. Annette Bernard (Private Practice)
Atlanta, Georgia, United States, 30308
AIDS Research Consortium of Atlanta (ARCA) Central
Atlanta, Georgia, United States, 30308
Absolute Care Clinic
Atlanta, Georgia, United States, 30308
Cobb-Douglas County Infectious Disease Clinic
Atlanta, Georgia, United States, 30308
Dekalb County Health Dept Infectious Disease
Atlanta, Georgia, United States, 30308
Dr. Richard Hudson (Private Practice)
Atlanta, Georgia, United States, 30308
Dr. Dennis Melton (Private Practice)
Atlanta, Georgia, United States, 30308
AID Atlanta/Morehouse Med School Ryan White Cl
Atlanta, Georgia, United States, 30308
United States, Idaho
HIV Services Clinic/Family Practice Medical Center
Boise, Idaho, United States, 83704
United States, Illinois
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
Cook County Hosp
Chicago, Illinois, United States, 606576156
Klein and Slotten Associates / AIDS Research Alliance
Chicago, Illinois, United States, 606576156
University of Chicago
Chicago, Illinois, United States, 60657
University of Illinois at Chicago
Chicago, Illinois, United States, 606576156
Northwestern Memorial Physicians
Chicago, Illinois, United States, 60657
Northside Family Medicine
Chicago, Illinois, United States, 60657
Lakeshore Infectious Disease Associates
Chicago, Illinois, United States, 606576156
Southern Illinois University (SIU) School of Medicine
Springfield, Illinois, United States, 62702
United States, Kansas
KU Medical School-Wichita, MPA
Wichita, Kansas, United States, 37214-3199
KU Medical School-Wichita, Midtown Clinic
Wichita, Kansas, United States, 37214-3199
United States, Louisiana
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States, 70112
Our Lady of the Lake Regional Med Ctr
New Orleans, Louisiana, United States, 701122699
University of Mississippi Medical Center
New Orleans, Louisiana, United States, 70112-2699
United States, Massachusetts
Community Research Initiatives of New England
Boston, Massachusetts, United States, 02215
Community Research Initiatives/ProACT
Boston, Massachusetts, United States, 02215
Community Research Initiative/ProACT
Springfield, Massachusetts, United States, 01107
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48100-0378
Wayne State Univ / Medical College of Ohio at Toledo
Detroit, Michigan, United States, 48201
Detroit Community Health Connection
Detroit, Michigan, United States, 48201
Providence Hosp- Newland Med Assoc. Inc.
Detroit, Michigan, United States, 48202
Henry Ford Hosp
Detroit, Michigan, United States, 48202
Mt. Clemens General Hospital
Detroit, Michigan, United States, 48202
Detroit Receiving
Detroit, Michigan, United States, 48201
McAuley Health Center
Grand Rapids, Michigan, United States, 49503
Michigan State University Infectious Diseases Clinic
Lansing, Michigan, United States, 48910
William Beaumont Hospital/CORNET
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mayo Clinic/CORNET
Rochester, Minnesota, United States, 55905
United States, New Jersey
Cooper Hospital Early Intervention Program
Camden, New Jersey, United States, 08103
Jersey Shore Med Ctr
Neptune, New Jersey, United States, 07753
Jeffrey Bomser Clinic / NJCR
Newark, New Jersey, United States, 07103
Saint Michael's Med Ctr
Newark, New Jersey, United States, 071032842
Raritan Bay Med Ctr
Newark, New Jersey, United States, 071032842
NJCRI
Newark, New Jersey, United States, 07103
New Jersey Community Research Initiative
Newark, New Jersey, United States, 07103
South Jersey Infectious Disease
Somers Poinnt, New Jersey, United States, 08244
United States, New York
Bronx-Lebanon Hosp Ctr
Bronx, New York, United States, 10453
Bronx Veterans Affairs Medical Center
Bronx, New York, United States, 10468
SUNY Downstate Med Ctr
Brooklyn, New York, United States, 11023
Metropolitan Hospital Center
New York, New York, United States, 10039
Lincoln Medical & Mental Health Center
New York, New York, United States, 10037
Syndenham Neighborhood Family Care Ctr
New York, New York, United States, 10037
HHC MMC Unit #1
New York, New York, United States, 10037
Jacobi Medical Center
New York, New York, United States, 10037
Lenox Avenue Health Ctr
New York, New York, United States, 10037
Grant Houses Health Ctr
New York, New York, United States, 10037
Polo Grounds Health Care Ctr
New York, New York, United States, 10037
HHC Outpatient Clinics
New York, New York, United States, 10037
United States, North Carolina
Wake Forest Univ Health Sciences
Winston-Salem, North Carolina, United States, 27157-1042
United States, Oklahoma
Univ of Oklahoma Health Sciences
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
The Research and Education Group
Portland, Oregon, United States, 97210
The Research & Education Grp / Oregon Hlth Sci Univ
Portland, Oregon, United States, 972105311
The Rsch & Ed Grp / Legacy Cln at Good Samaritan
Portland, Oregon, United States, 972105311
The Research & Education Group / Multomah Cnty Hlth Dept
Portland, Oregon, United States, 972105311
Legacy Clinic NE
Portland, Oregon, United States, 97209-2534
The Research & Education Group / The R & E Grp Office
Portland, Oregon, United States, 972105311
Salem Hospital
Portland, Oregon, United States, 97209-2534
The Rsch & Ed Grp / Providence Portland Med Ctr
Portland, Oregon, United States, 972105311
United States, Pennsylvania
Penn Community Infectious Diseases
Philadelphia, Pennsylvania, United States, 19107
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
Temple Univ School of Medicine
Philadelphia, Pennsylvania, United States, 19140
Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Houston Veterans Administration Med Ctr
Houston, Texas, United States, 77030
Univ TX Health Science Ctr
Houston, Texas, United States, 77030
Montrose Clinic
Houston, Texas, United States, 77006
University Clinical Research Center
Houston, Texas, United States, 77030
South Texas Veterans Health Care System
San Antonio, Texas, United States, 78229
United States, Virginia
Infectious Disease Associates of Virginia
Lynchburg, Virginia, United States, 24501
South Richmond Health Ctr
Richmond, Virginia, United States, 23298
Cross Over Clinic / Div of Infectious Diseases
Richmond, Virginia, United States, 232980049
Petersburg Health Care Alliance
Richmond, Virginia, United States, 23298
MCV ID Clinic
Richmond, Virginia, United States, 23298
McGuire VA / Division of Infectious Diseases
Richmond, Virginia, United States, 232980049
Vernon J. Harris East End Community Health Care Ct
Richmond, Virginia, United States, 23298
MediCorp, Infectious Disease Associates
Richmond, Virginia, United States, 23298
United States, Wisconsin
University Of Wisconsin Hospital and Clinics/CORNET, HIV Care Program
Madison, Wisconsin, United States, 53792
Argentina
Hospital Gn'l de Agudos T. Alvarez
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
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 Rawson
Cordoba, Argentina
Hospital Interzonall de San Juan de Dios
La Plata, Argentina
Hospital Central
Mendoza, Argentina
CAICI
Rosario, Argentina
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Australia, Victoria
Prahran Market Clinic
South Yarra, Victoria, Australia
The Centre Clinic
South Yarra, Victoria, Australia
Australia
Burwood Street General Pratice
Burwood Nsw, Australia, 2134
Royal Perth Hosp
Perth, Australia
Royal Prince Alfred Hospital
Prahan, Australia
Alfred Hosp
Prahan, Australia
National Centre in HIV Epidemiology and Clinical Research
Sydney, Australia
Austria
University of Vienna Medical School, AKH
Vienna, Austria, A-1090
Belgium
Institute of Tropical Medicine
Antwerp, Belgium, 2000
Centre Hospitalier Universitaire Sart-Tilman
Liege, Belgium, 4000
Brazil
Hospital Escola Sao Francisco de Asis
Rio de Janeiro, RJ, Brazil, 20210.030
Hospital Nossa Senhora da Conceicao
Porto Alegre, RS, Brazil, 91350-200
Instituto de Infectologia Emilio Ribas
Sao Paulo, S.p. Cep, Brazil, 01246
Centro de Pesquisa Clinical do Hospital Guilherme
Boqueirao-Santos, Brazil, 11045-904
Cassiano Antonio de Moraes University Hospital
Boqueirao-Santos, Brazil, 11045-904
Hospital de Clinicas de Porto Alegre
Porto Alegre-RS Cep, Brazil, 90035
Hospital dos Servidores do Estado
Rio de Janeiro, Brazil, 20221-903
Hospital Universitario Professor Edgard Santos
Salvador-BA, Brazil, 110-160
Unidade de Pesquisa Clinica
San Paulo, Brazil, 13083-970
Centro de Referencia e Treinamento DST/AIDS
San Paulo, Brazil, 04121-000
Ambulatorio de Imunodeficiencias Secundarias/Der30
Sao Paulo, Brazil, 01246-900
Universidade Federal De Sao Paulo-Hospital Sao Paulo
Sao Paulo, Brazil, 04040-002
Canada, British Columbia
Downtown Infectious Disease Clinic
Vancouver, British Columbia, Canada, V6Z 2C7
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, NS B3H 1V7
Canada, Ontario
Hamilton Health Science Centre-McMaster
Hamilton, Ontario, Canada, L8N 3Z5
St. Josephs Hospital
London, Ontario, Canada
St. Joseph's Health Care Centre of London
London, Ontario, Canada, N5Y 3H6
The HAVEN Program, HRSRH
Sudbury, Ontario, Canada, P3E 5J1
Tronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
HIV Care Program, Windsor Regional Hospital
Windsor, Ontario, Canada, N8W 1E3
Canada, Quebec
University de Sherbrooke
Fleurimont, Quebec, Canada, JIH 5N4
Clinique Medicale L'actuel
Montreal, Quebec, Canada, H2L 4P9
Montreal Chest Institute/Royal Victoria Hospital
Montreal, Quebec, Canada, H2X 2P4
Centre hospitalier de l'universite Laval (CHUL)
Sainte-Foy, Quebec, Canada, F1V 4G2
Recherche Clinique Centre Medical Halles de Saint-
Ste-Foy, Quebec, Canada, G1V 4P9
Estonia
West-Tallinn Central Hospital
Tallinn, Estonia, 10617
France
CHU de la Region Annecienne
Annecy, France, 74011
Hopital Pellegrin
Bordeaux, France, 33076
Centre Hospitalier Universitaire
Chu-grenoble, France
Hopital Louis Mourier
Colombes, France
Hopital Sainte-Marguerite
Marseille, France, 13009
Hopital Pitie Salpetriere
Paris, France, 75651
Hopital Saint-Louis
Paris, France, 75010
Germany
Klinik fur Dermatologie, Venerologie, Allergologie
Essen, Germany, 45122
Johann Wolfgang Goethe University Hospital
Frankfort, Germany, 60590
Klinikum der Ruprecht-Karis-Universitat (U. Hospital)
Heidelberg, Germany, D-69115
University Hospital Zurich
Zurich Ch-, Germany, 8091
Ireland
St. James Hospital
Dublin 8, Ireland
Israel
Ramathibodi Hospital
Tel Aviv, Israel, 64239
Italy
U.O. Malattie Infettive, H.S.Maria Annunziata
Antella-Firenze, Italy, 50011
SOCDU Malattie Infettive Ospedale Civile Asti
Asti, Italy, 14100
Instituto de Malattie Infettive e Tropicali
Brescia, Italy, I-25125
Malattie Infettive Busto
Busto Arsizio (va), Italy, 21052
Universita degli Studi di Modena e Reggio Emilia
Modena, Italy, 41100
Clinica Malattie Infettive
Pavia, Italy, 27100
I.R.C.C.S."L.Spallanzani"
Rome, Italy, 00149
University of Turin
Torino, Italy, 10149
Servizio Regionale di Immunologia Clinica e Tipizz
Torrette Di Ancona, Italy, 71-60020
S.S. Giovanni e Paolo Hospital
Venice, Italy
Japan
International Medical Center of Japan
Tokyo, Japan, 162-8655
AIDS Medical Center, International Medical Center
Tokyo, Japan, 162-8655
Lithuania
Lithuanian AIDS center
Vilnius, Lithuania, 03011
Luxembourg
Centre Hospitalier de Luxembourg
Barble, Luxembourg, L-1210
Martinique
C.H.U. Fort-de-France
Fort-de-france, Martinique, 97261
New Zealand
Christchurch Hosp
Christchurch, New Zealand
Wellington Hosp
Wellington, New Zealand
Norway
Ulleval Hospital
Oslo, Norway, N-0407
Peru
Hospital Nacional Edgardo Rebagliati Martins
Lima, Peru, 11
Hospital Nacional Guillermo Almenara Irigoyen
Lima, Peru, 13
Poland
Wroclaw University School of Medicine
Koszarowa Str. 5, Poland
Puerto Rico
Instituto A. Z. de Pesquisa e Ensino
Curitiba, Puerto Rico, 80430-040
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, E08025
Hospital Universitario Principe de Asturias
Madrid, Spain, E-28805
Hospital Universitario de La Princesa
Madrid, Spain, E-28006
Hospital U. Virgen del Rocio
Sevilla, Spain, 41013
Hospital Mutua de Terrassa
Terrassa, Spain, 08221
Consorcio Hospital General Universitario de Valencia
Valencia, Spain, 46014
Switzerland
University Hospital Basel
Basel Ch, Switzerland, 4031
Poliklinik fur Infektiologie
Bern, Switzerland, 3010
Hopital de la Ville
La Chaux-de-Fonds, Switzerland, 2300
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011
Ospedale Regionale di Lugano
Lugano, Switzerland, 6903
Thailand
Sanpatong Hospital
Chiang Mai, Thailand, 50120
Bamrasnaradura Institute
Nonthaburi 11000, Thailand
United Kingdom
John Radcliffe Hospital
Oxford, England, United Kingdom, OX3 9DU
Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA
Hawthorn House, Birmingham Heartlands NHS Trust
Birmingham, United Kingdom, B9 5SS
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
St. Helier Hospital
Carshalton, United Kingdom, SM5, 1AA
St. Helier Hospital
Carshalton, Surrey, United Kingdom, SM5, 1AA
Essex County Hospital
Essex, United Kingdom, CO3 3NB
Victoria General Hospital, Q.E. II Health Sciences
Halifax, United Kingdom
Royal Free Hospital
London, United Kingdom, NW3 2QG
St. George's Hospital
London, United Kingdom, SW17 ORE
St. Mary's Hospital
London, United Kingdom, W1 2NY
The Mortimer Market Center
London, United Kingdom, WC1E 6AU
Central Middlesex Hospital
London, United Kingdom, NW10 7NS
Homerton University Hospital NHS Foundation Trust
London, United Kingdom, E9 6SR
Barts and The London, NHS Trust
London, United Kingdom, EC1A 7BE
T1 Coleridge Unit, North Middlesex Hospital
London, United Kingdom, SE5 9RS
St. Thomas' Hospital
London, United Kingdom, SE1 7EH
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
The Caldecot Centre, Kings College Hospital NHS Tr
London, United Kingdom, SE5 9RS
The James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Pasteur Suite, Ealing Hospital
Middlesex, United Kingdom, UB1 3HW
Newcastle General Hospital
Newcastle, United Kingdom, NE4 6BE
Dept. of Infection and Tropical Medicine - Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Watford Sexual Health Center;Watford General Hosp
Watford Wd, United Kingdom, 18 0HB
Sponsors and Collaborators
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00027352     History of Changes
Other Study ID Numbers: CPCRA 065, SMART
Study First Received: December 4, 2001
Last Updated: November 24, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Physician's Practice Patterns
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 30, 2014