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

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

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 CPCRA FIRST, MDR-HIV, or NvR study or another study which is not consistent with one of the treatment groups in this study
• Pregnant or breast-feeding

California
      Community Consortium / UCSF, San Francisco,  California,  94110,  United States; Recruiting
      East Bay AIDS Ctr, San Francisco,  California,  94110,  United States; Recruiting
      Lawrence Goldyn, MD, San Francisco,  California,  94110,  United States; Recruiting
      AIDS Healthcare Foundation, Los Angeles,  California,  90015,  United States; Recruiting
      Los Angeles Gay and Lesbian Community Service Ctr, Los Angeles,  California,  90028,  United States; Recruiting
      Dr. Shawn Hassler, San Francisco,  California,  94110,  United States; Recruiting
Colorado
      Denver CPCRA / Denver Public Hlth, Denver,  Colorado,  802044507,  United States; Recruiting
      Western Infectious Disease Consultants, Denver,  Colorado,  80204-4507,  United States; Recruiting
Connecticut
      Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit, New Haven,  Connecticut,  065102483,  United States; Recruiting
      Veterans Administration Medical Center, New Haven,  Connecticut,  06510,  United States; Recruiting
Delaware
      Christiana Care Health Services HIV Program George, Wilmington,  Delaware,  19801,  United States; Recruiting
District of Columbia
      Washington Reg AIDS Prog / Dept of Infect Dis, Washington,  District of Columbia,  20422,  United States; Recruiting
      Timothy A Price, Washington,  District of Columbia,  204220001,  United States; No longer recruiting
      George Washington Univ, Washington,  District of Columbia,  20422,  United States; No longer recruiting
Florida
      Treasure Coast Infectious Disease Consultants, Vero Beach,  Florida,  32960,  United States; Recruiting
      Miami Veterans Affairs Med Ctr, Miami,  Florida,  33125,  United States; Recruiting
Georgia
      AIDS Research Consortium of Atlanta (ARCA) Central, Atlanta,  Georgia,  30308,  United States; Recruiting
      Absolute Care Clinic, Atlanta,  Georgia,  30308,  United States; Recruiting
      AID Atlanta/Morehouse Med School Ryan White Cl, Atlanta,  Georgia,  30308,  United States; Recruiting
      Cobb-Douglas County Infectious Disease Clinic, Atlanta,  Georgia,  30308,  United States; Recruiting
      Dekalb County Health Dept Infectious Disease, Atlanta,  Georgia,  30308,  United States; Recruiting
      Dr. Richard Hudson (Private Practice), Atlanta,  Georgia,  30308,  United States; Recruiting
      Dr. Dennis Melton (Private Practice), Atlanta,  Georgia,  30308,  United States; Recruiting
      Dr. Melanie Thompson and Dr. Annette Bernard (Private Practice), Atlanta,  Georgia,  30308,  United States; Recruiting
Illinois
      AIDS Research Alliance - Chicago, Chicago,  Illinois,  60657,  United States; Recruiting
      Cook County Hosp, Chicago,  Illinois,  606576156,  United States; Recruiting
      Klein and Slotten Associates / AIDS Research Alliance, Chicago,  Illinois,  606576156,  United States; Recruiting
      Lakeshore Infectious Disease Associates, Chicago,  Illinois,  606576156,  United States; Recruiting
      University of Illinois at Chicago, Chicago,  Illinois,  606576156,  United States; Recruiting
      Northwestern Memorial Physicians, Chicago,  Illinois,  60657,  United States; Recruiting
      Northside Family Medicine, Chicago,  Illinois,  60657,  United States; Recruiting
      University of Chicago, Chicago,  Illinois,  60657,  United States; Recruiting
      Southern Illinois University (SIU) School of Medicine, Springfield,  Illinois,  62702,  United States; Recruiting
Louisiana
      Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans,  Louisiana,  70112,  United States; Recruiting
      Our Lady of the Lake Regional Med Ctr, New Orleans,  Louisiana,  701122699,  United States; Recruiting
      University of Mississippi Medical Center, New Orleans,  Louisiana,  70112-2699,  United States; Recruiting
Massachusetts
      Community Research Initiative/ProACT, Springfield,  Massachusetts,  01107,  United States; Recruiting
      Community Research Initiatives/ProACT, Boston,  Massachusetts,  02215,  United States; Recruiting
      Community Research Initiatives of New England, Boston,  Massachusetts,  02215,  United States; Recruiting
Michigan
      Henry Ford Hosp, Detroit,  Michigan,  48202,  United States; Recruiting
      Detroit Receiving, Detroit,  Michigan,  48201,  United States; Recruiting
      Wayne State Univ / Medical College of Ohio at Toledo, Detroit,  Michigan,  48201,  United States; No longer recruiting
      Providence Hosp- Newland Med Assoc. Inc., Detroit,  Michigan,  48202,  United States; Recruiting
      William Beaumont Hospital/CORNET, Royal Oak,  Michigan,  48073,  United States; Recruiting
      Mt. Clemens General Hospital, Detroit,  Michigan,  48202,  United States; Recruiting
      Detroit Community Health Connection, Detroit,  Michigan,  48201,  United States; Recruiting
Minnesota
      Mayo Clinic/CORNET, Rochester,  Minnesota,  55905,  United States; Recruiting
New Jersey
      Jersey Shore Med Ctr, Neptune,  New Jersey,  07753,  United States; Recruiting
      New Jersey Community Research Initiative, Newark,  New Jersey,  07103,  United States; Recruiting
      Raritan Bay Med Ctr, Newark,  New Jersey,  071032842,  United States; Recruiting
      Saint Michael's Med Ctr, Newark,  New Jersey,  071032842,  United States; Recruiting
      Cooper Hospital Early Intervention Program, Camden,  New Jersey,  08103,  United States; Recruiting
      NJCRI, Newark,  New Jersey,  07103,  United States; Recruiting
      Jeffrey Bomser Clinic / NJCR, Newark,  New Jersey,  07103,  United States; Recruiting
      South Jersey Infectious Disease, Somers Poinnt,  New Jersey,  08244,  United States; Recruiting
New York
      Bronx-Lebanon Hosp Ctr, Bronx,  New York,  10453,  United States; Recruiting
      HHC MMC Unit #1, New York,  New York,  10037,  United States; Recruiting
      Lenox Avenue Health Ctr, New York,  New York,  10037,  United States; Recruiting
      Polo Grounds Health Care Ctr, New York,  New York,  10037,  United States; Recruiting
      Grant Houses Health Ctr, New York,  New York,  10037,  United States; Recruiting
      Syndenham Neighborhood Family Care Ctr, New York,  New York,  10037,  United States; Recruiting
      HHC Outpatient Clinics, New York,  New York,  10037,  United States; Recruiting
      Jacobi Medical Center, New York,  New York,  10037,  United States; Recruiting
      SUNY Downstate Med Ctr, Brooklyn,  New York,  11023,  United States; Recruiting
      Metropolitan Hospital Center, New York,  New York,  10039,  United States; Recruiting
      Bronx Veterans Affairs Medical Center, Bronx,  New York,  10468,  United States; Recruiting
North Carolina
      Wake Forest Univ Health Sciences, Winston Salem,  North Carolina,  27157-1042,  United States; Recruiting
Oklahoma
      Univ of Oklahoma Health Sciences, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Oregon
      The Research and Education Group, Portland,  Oregon,  97210,  United States; Recruiting
      The Research & Education Grp / Oregon Hlth Sci Univ, Portland,  Oregon,  972105311,  United States; Recruiting
      The Rsch & Ed Grp / Legacy Cln at Good Samaritan, Portland,  Oregon,  972105311,  United States; Recruiting
      The Rsch & Ed Grp / Providence Portland Med Ctr, Portland,  Oregon,  972105311,  United States; Recruiting
      The Research & Education Group / Multomah Cnty Hlth Dept, Portland,  Oregon,  972105311,  United States; Recruiting
      The Research & Education Group / The R & E Grp Office, Portland,  Oregon,  972105311,  United States; Recruiting
      Salem Hospital, Portland,  Oregon,  97209-2534,  United States; Recruiting
      Legacy Clinic NE, Portland,  Oregon,  97209-2534,  United States; Recruiting
Pennsylvania
      Temple Univ School of Medicine, Philadelphia,  Pennsylvania,  19140,  United States; Recruiting
      Philadelphia FIGHT, Philadelphia,  Pennsylvania,  19107,  United States; Suspended
      Einstein Medical Center, Philadelphia,  Pennsylvania,  19140,  United States; Recruiting
Texas
      Houston Veterans Administration Med Ctr, Houston,  Texas,  77030,  United States; Recruiting
      Univ TX Health Science Ctr, Houston,  Texas,  77030,  United States; Recruiting
      Montrose Clinic, Houston,  Texas,  77006,  United States; Recruiting
      South Texas Veterans Health Care System, San Antonio,  Texas,  78229,  United States; Recruiting
      University Clinical Research Center, Houston,  Texas,  77030,  United States; Recruiting
Virginia
      MCV ID Clinic, Richmond,  Virginia,  23298,  United States; Recruiting
      South Richmond Health Ctr, Richmond,  Virginia,  23298,  United States; Recruiting
      Cross Over Clinic / Div of Infectious Diseases, Richmond,  Virginia,  232980049,  United States; Recruiting
      McGuire VA / Division of Infectious Diseases, Richmond,  Virginia,  232980049,  United States; Recruiting
      Vernon J. Harris East End Community Health Care Ct, Richmond,  Virginia,  23298,  United States; Recruiting
      Petersburg Health Care Alliance, Richmond,  Virginia,  23298,  United States; Recruiting
Argentina
      Hospital Gn'l de Agudos JM Ramos Mejia, Buenos Aires,  Argentina; Recruiting
      Hospital Italiano de Buenos Aires, Buenos Aires,  Argentina; Recruiting
      Hospital de Clinicas Jose de San Martin, Buenos Aires,  Argentina; Recruiting
      Hospital de Infecciosas F.J. Muniz, Buenos Aires,  Argentina; Recruiting
      CAICI, Rosario,  Argentina; Recruiting
      Hospital Interzonall de San Juan de Dios, La Plata,  Argentina; Recruiting
      Hospital Gn'l de Agudos T. Alvarez, Buenos Aires,  Argentina; Recruiting
      Hospital Rawson, Cordoba,  Argentina; Recruiting
      Hospital Central, Mendoza,  Argentina; Recruiting
Australia
      Alfred Hosp, Prahan,  Australia; Recruiting
      National Centre in HIV Epidemiology and Clinical Research, Sydney,  Australia; Recruiting
      Royal Perth Hosp, Perth,  Australia; Recruiting
      Royal Prince Alfred Hospital, Prahan,  Australia; Recruiting
      Burwood Street General Pratice, Burwood NSW,  2134,  Australia; Recruiting
Australia, South Australia
      Royal Adelaide Hospital, Adelaide,  South Australia,  Australia; Recruiting
Australia, Victoria
      Prahran Market Clinic, South Yarra,  Victoria,  Australia; Recruiting
      The Centre Clinic, South Yarra,  Victoria,  Australia; Recruiting
Canada, Nova Scotia
      Queen Elizabeth II Health Sciences Centre, Halifax,  Nova Scotia,  NS B3H 1V7,  Canada; Recruiting
Canada, Ontario
      St. Josephs Hospital, London,  Ontario,  Canada; Recruiting
      HIV Care Program, Windsor Regional Hospital, Windsor,  Ontario,  N8W 1E3,  Canada; Recruiting
      HIV Care Program, Windsor Regional Hospital, Windsor,  Ontario,  N8W 1E3,  Canada; Recruiting
      St. Joseph's Health Care Centre of London, London,  Ontario,  N5Y 3H6,  Canada; Recruiting
      Hamilton Health Science Centre-McMaster, Hamilton,  Ontario,  L8N 3Z5,  Canada; Recruiting
      Tronto General Hospital, Toronto,  Ontario,  M5G 2N2,  Canada; Recruiting
Canada, Quebec
      Clinique Medicale L'actuel, Montreal,  Quebec,  H2L 4P9,  Canada; Recruiting
      Centre hospitalier de l'universite Laval (CHUL), Sainte-Foy,  Quebec,  F1V 4G2,  Canada; Recruiting
      Recherche Clinique Centre Medical Halles de Saint-, Ste Foy,  Quebec,  G1V 4P9,  Canada; Recruiting
      University de Sherbrooke, Fleurimont,  Quebec,  JIH 5N4,  Canada; Recruiting
Germany
      Johann Wolfgang Goethe University Hospital, Frankfort,  60590,  Germany; Recruiting
      Klinikum der Ruprecht-Karis-Universitat (U. Hospital), Heidelberg,  D-69115,  Germany; Recruiting
Japan
      International Medical Center of Japan, Tokyo,  162-8655,  Japan; Recruiting
      AIDS Medical Center, International Medical Center, Tokyo,  162-8655,  Japan; Recruiting
New Zealand
      Wellington Hosp, Wellington,  New Zealand; Recruiting
      Christchurch Hosp, Christchurch,  New Zealand; Recruiting
Norway
      Ulleval Hospital, Oslo,  N-0407,  Norway; Recruiting
Poland
      Wroclaw University School of Medicine, Koszarowa str. 5,  Poland; Recruiting
United Kingdom
      Royal Victoria Hospital, Belfast,  BT12 6BA,  United Kingdom; Recruiting
      Victoria General Hospital, Q.E. II Health Sciences, Halifax,  United Kingdom; Recruiting
      St. George's Hospital, London,  SW17 ORE,  United Kingdom; Recruiting
      St. Mary's Hospital, London,  W1 2NY,  United Kingdom; No longer recruiting
      Central Middlesex Hospital, London,  NW10 7NS,  United Kingdom; Recruiting
      St. Helier Hospital, Carshalton,  SM5, 1AA,  United Kingdom; Recruiting
      St. Thomas' Hospital, London,  SE1 7EH,  United Kingdom; Recruiting
      Watford Sexual Health Center;Watford General Hosp, Watford WD,  18 0HB,  United Kingdom; Recruiting
      T1 Coleridge Unit, North Middlesex Hospital, London,  SE5 9RS,  United Kingdom; Recruiting
      St. Mary's Hospital, London,  W1 2NY,  United Kingdom; Recruiting
      Central Middlesex Hospital, London,  NW10 7NS,  United Kingdom; Recruiting
      St. Helier Hospital, Carshalton, Surrey,  SM5, 1AA,  United Kingdom; Recruiting
      Chelsea and Westminster Hospital, London,  SW10 9NH,  United Kingdom; Recruiting
      The Mortimer Market Center, London,  WC1E 6AU,  United Kingdom; Recruiting
      Newcastle General Hospital, Newcastle,  NE4 6BE,  United Kingdom; Recruiting
      Royal Free Hospital, London,  NW3 2QG,  United Kingdom; Recruiting
United Kingdom, England
      John Radcliffe Hospital, Oxford,  England,  OX3 9DU,  United Kingdom; Recruiting

Study chairs or principal investigators

Wafaa El-Sadr, MD, MPH,  Study Chair,  Harlem AIDS Treatment Group, Harlem Hospital Center   
James Neaton, PhD,  Study Chair,  CPCRA Statistcal and Data Management Center / CCBR   

Study ID Numbers:  CPCRA 065; SMART
Record last reviewed:  November 2004
Record first received:  December 4, 2001
ClinicalTrials.gov Identifier:  NCT00027352
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08