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Home > "A" Clinical Trials Conditions > A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)  A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)
A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Observational, Natural History, Longitudinal, Defined Population, Prospective Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 6000
Location and Contact Information:
Overall Study Official:
JamesNeaton, Study Chair, CPCRA Statistcal and Data Management Center / CCBR
MCV ID Clinic *Recruiting*
Richmond, Virginia, 23298
United States
Recruiting Vinnie Mitchell 804-828-2477
HHC MMC Unit #1 *Recruiting*
New York City, New York, 10037
United States
Recruiting Luis Fuentes 212-939-2957
Royal Perth Hosp *Recruiting*
Perth, ,
Australia
Recruiting Jenny Leung 61 8 9224 3429
Christiana Care Health Services HIV Program George *Recruiting*
Wilmington, Delaware, 19801
United States
Recruiting Karen Swanson 302-255-1319
Bronx-Lebanon Hosp Ctr *Recruiting*
Bronx, New York, 10453
United States
Recruiting Elizabeth Doramajian 718-901-6346
The Research and Education Group *Recruiting*
Portland, Oregon, 97210
United States
Recruiting Susan Peterson 503-229-8428
Dr. Dennis Melton (Private Practice) *Recruiting*
Atlanta, Georgia, 30308
United States
Recruiting Bentley Sweeton 404-876-2317
Wayne State Univ / Medical College of Ohio at Toledo *No longer recruiting*
Detroit, Michigan, 48201
United States
No longer recruiting
The Research & Education Grp / Oregon Hlth Sci Univ *Recruiting*
Portland, Oregon, 972105311
United States
Recruiting Norma Martinez 503-229-8428
Dekalb County Health Dept Infectious Disease *Recruiting*
Atlanta, Georgia, 30308
United States
Recruiting Bentley Sweeton 404-876-2317
Jersey Shore Med Ctr *Recruiting*
Neptune, New Jersey, 07753
United States
Recruiting Dawn McIntyre 732-776-4709
Cross Over Clinic / Div of Infectious Diseases *Recruiting*
Richmond, Virginia, 232980049
United States
Recruiting Vinnie Mitchell 804-828-2477
Ulleval Hospital *Recruiting*
Oslo, , N-0407
Norway
Recruiting Astrid Rudi 47-22-11-91-12
Grant Houses Health Ctr *Recruiting*
New York City, New York, 10037
United States
Recruiting Luis Fuentes 212-939-2957
Philadelphia FIGHT *Suspended*
Philadelphia, Pennsylvania, 19107
United States
Suspended
Wroclaw University School of Medicine *Recruiting*
Koszarowa str. 5, ,
Poland
Recruiting Brygida Knysz +01 48 71 325 52 42
Klein and Slotten Associates / AIDS Research Alliance *Recruiting*
Chicago, Illinois, 606576156
United States
Recruiting Rita Verheggen 773-244-5802
NJCRI *Recruiting*
Newark, New Jersey, 07103
United States
Recruiting Kerry Gristi 973-483-3444
The Rsch & Ed Grp / Providence Portland Med Ctr *Recruiting*
Portland, Oregon, 972105311
United States
Recruiting Norman Martinez 503-229-8428
Houston Veterans Administration Med Ctr *Recruiting*
Houston, Texas, 77030
United States
Recruiting Katharine Breaux 713-794-7943
Southern Illinois University (SIU) School of Medicine *Recruiting*
Springfield, Illinois, 62702
United States
Recruiting Lori Koch 217-545-7137
University of Chicago *Recruiting*
Chicago, Illinois, 60657
United States
Recruiting Edward Goodwin 773-244-5804
Hospital de Infecciosas F.J. Muniz *Recruiting*
Buenos Aires, ,
Argentina
Recruiting Aldo Maranzana 01-5411-4306-0656
Syndenham Neighborhood Family Care Ctr *Recruiting*
New York City, New York, 10037
United States
Recruiting Luis Fuentes 212-939-2957
Community Research Initiatives/ProACT *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Sandy Sheble-Hall 617-778-5454
The Research & Education Group / The R & E Grp Office *Recruiting*
Portland, Oregon, 972105311
United States
Recruiting Norma Martinez 503-229-8428
Royal Victoria Hospital *Recruiting*
Belfast, , BT12 6BA
United Kingdom
Recruiting Sinead McKernan 011-028 90634548
The Rsch & Ed Grp / Legacy Cln at Good Samaritan *Recruiting*
Portland, Oregon, 972105311
United States
Recruiting Norma Martinez 503-229-8428
Community Research Initiatives of New England *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Sandy Sheble-Hall 617-778-5454
Hospital Italiano de Buenos Aires *Recruiting*
Buenos Aires, ,
Argentina
Recruiting Marisa Lujan Sanchez 01-541-149-5903093
Absolute Care Clinic *Recruiting*
Atlanta, Georgia, 30308
United States
Recruiting Bentley Sweeton 404-876-2317
Dr. Richard Hudson (Private Practice) *Recruiting*
Atlanta, Georgia, 30308
United States
Recruiting Bentley Sweeton 404-876-2317
Alfred Hosp *Recruiting*
Prahan, ,
Australia
Recruiting Sally Algar 03 9276 6908
The Research & Education Group / Multomah Cnty Hlth Dept *Recruiting*
Portland, Oregon, 972105311
United States
Recruiting Norma Martinez 503-229-8428
Detroit Receiving *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Martha Farrough 313-745-4431
The Centre Clinic *Recruiting*
South Yarra, Victoria,
Australia
Recruiting Helen Wood 61-3 9826 4500
SUNY Downstate Med Ctr *Recruiting*
Brooklyn, New York, 11023
United States
Recruiting Ronald Harris 718-270-4487
Providence Hosp- Newland Med Assoc. Inc. *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Linda Makohon 313-916-2570
South Richmond Health Ctr *Recruiting*
Richmond, Virginia, 23298
United States
Recruiting Vinnie Mitchell 804-828-2477
Hospital Gn'l de Agudos T. Alvarez *Recruiting*
Buenos Aires, ,
Argentina
Recruiting Graciela Guaragna 01-54-11-4611-6666
CAICI *Recruiting*
Rosario, ,
Argentina
Recruiting Carla Somenzini 01-54-341-424-8045
Royal Prince Alfred Hospital *Recruiting*
Prahan, ,
Australia
Recruiting Marry Moussa 61-2 9515 6111
Washington Reg AIDS Prog / Dept of Infect Dis *Recruiting*
Washington D.C., District of Columbia, 20422
United States
Recruiting Barbara Standridge 202-745-8301
Hospital Interzonall de San Juan de Dios *Recruiting*
La Plata, ,
Argentina
Recruiting Jorge Contarelli 01-54-221-425-2326
Lenox Avenue Health Ctr *Recruiting*
New York City, New York, 10037
United States
Recruiting Luis Fuentes 212-939-2957
Raritan Bay Med Ctr *Recruiting*
Newark, New Jersey, 071032842
United States
Recruiting Robert Sawyer 973-483-3444
Miami Veterans Affairs Med Ctr *Recruiting*
Miami, Florida, 33125
United States
Recruiting Mack Smith 305-324-4455
AIDS Research Alliance - Chicago *Recruiting*
Chicago, Illinois, 60657
United States
Recruiting Rita Verheggen 773-244-5802
Denver CPCRA / Denver Public Hlth *Recruiting*
Denver, Colorado, 802044507
United States
Recruiting Jack Rouff 303-436-7184
Univ of Oklahoma Health Sciences *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Brenda Verel 405-271-8001
Timothy A Price *No longer recruiting*
Washington D.C., District of Columbia, 204220001
United States
No longer recruiting
George Washington Univ *No longer recruiting*
Washington D.C., District of Columbia, 20422
United States
No longer recruiting
Los Angeles Gay and Lesbian Community Service Ctr *Recruiting*
Los Angeles, California, 90028
United States
Recruiting Minh Tran 323-860-7330
McGuire VA / Division of Infectious Diseases *Recruiting*
Richmond, Virginia, 232980049
United States
Recruiting Vinni Mitchell 804-828-2477
Johann Wolfgang Goethe University Hospital *Recruiting*
Frankfort, , 60590
Germany
Recruiting Kathleen Mantzsch 01 49 69 6301 5606
Hospital Gn'l de Agudos JM Ramos Mejia *Recruiting*
Buenos Aires, ,
Argentina
Recruiting Leonardo Lourtau 01-5411-4931-5252
Petersburg Health Care Alliance *Recruiting*
Richmond, Virginia, 23298
United States
Recruiting Martha Howe 804-828-6471
Hospital Rawson *Recruiting*
Cordoba, ,
Argentina
Recruiting Cristina Marson 01-54-351-434-8754
Jeffrey Bomser Clinic / NJCR *Recruiting*
Newark, New Jersey, 07103
United States
Recruiting Robert Sawyer 973-483-3444
Northside Family Medicine *Recruiting*
Chicago, Illinois, 60657
United States
Recruiting Rita Verheggen 773-244-5802
Polo Grounds Health Care Ctr *Recruiting*
New York City, New York, 10037
United States
Recruiting Luis Fuentes 212-939-2957
Montrose Clinic *Recruiting*
Houston, Texas, 77006
United States
Recruiting Brian Bell 713-830-3011
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit *Recruiting*
New Haven, Connecticut, 065102483
United States
Recruiting Laurie Andrews 203-785-3557
Cook County Hosp *Recruiting*
Chicago, Illinois, 606576156
United States
Recruiting Rita Verheggen 773-244-5802
Dr. Melanie Thompson and Dr. Annette Bernard (Private Practice) *Recruiting*
Atlanta, Georgia, 30308
United States
Recruiting Bentley Sweeton 404-876-2317
New Jersey Community Research Initiative *Recruiting*
Newark, New Jersey, 07103
United States
Recruiting Robert Sawyer 973-483-3444
Mayo Clinic/CORNET *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Ida Young 507-538-0033
Hospital Central *Recruiting*
Mendoza, ,
Argentina
Recruiting Eleonora Angel 01-54261-4201920
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Janice Walker 504-584-1971
International Medical Center of Japan *Recruiting*
Tokyo, , 162-8655
Japan
Recruiting Yoshimi Kikuchi 01-81-3-3202 7181
National Centre in HIV Epidemiology and Clinical Research *Recruiting*
Sydney, ,
Australia
Recruiting Jennifer Hoy 61 3 9276 6900
Lawrence Goldyn, MD *Recruiting*
San Francisco, California, 94110
United States
Recruiting Carroll Child 415-476-9554
William Beaumont Hospital/CORNET *Recruiting*
Royal Oak, Michigan, 48073
United States
Recruiting Julie Ventimiglio 248-551-4340
Prahran Market Clinic *Recruiting*
South Yarra, Victoria,
Australia
Recruiting Helen Wood 61-3 9826 4500
Jacobi Medical Center *Recruiting*
New York City, New York, 10037
United States
Recruiting Amina Oughourli 212-939-2926
Temple Univ School of Medicine *Recruiting*
Philadelphia, Pennsylvania, 19140
United States
Recruiting Kelly Lattanzi 215-707-8846
HHC Outpatient Clinics *Recruiting*
New York City, New York, 10037
United States
Recruiting Luis Fuentes 212-939-2957
Wake Forest Univ Health Sciences *Recruiting*
Winston Salem, North Carolina, 27157-1042
United States
Recruiting Sandra Hauser 336-716-4267
University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 606576156
United States
Recruiting Rita Verheggen 773-244-5802
Univ TX Health Science Ctr *Recruiting*
Houston, Texas, 77030
United States
Recruiting Hilda Cuervo 713-500-6751
Saint Michael's Med Ctr *Recruiting*
Newark, New Jersey, 071032842
United States
Recruiting Robert Sawyer 973-483-3444
East Bay AIDS Ctr *Recruiting*
San Francisco, California, 94110
United States
Recruiting Carroll Child 415-476-9554
AIDS Healthcare Foundation *Recruiting*
Los Angeles, California, 90015
United States
Recruiting Chris Rice 323-913-1033
AIDS Research Consortium of Atlanta (ARCA) Central *Recruiting*
Atlanta, Georgia, 30308
United States
Recruiting Bentley Sweeton 404-876-2317
Henry Ford Hosp *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Linda Makohon 313-916-2993
Royal Adelaide Hospital *Recruiting*
Adelaide, South Australia,
Australia
Recruiting Wendy Ferguson 61 8 8222 5635
Christchurch Hosp *Recruiting*
Christchurch, ,
New Zealand
Recruiting Alan Pithie 643-364-0951
AID Atlanta/Morehouse Med School Ryan White Cl *Recruiting*
Atlanta, Georgia, 30308
United States
Recruiting Bentley Sweeton 404-876-2317
Lakeshore Infectious Disease Associates *Recruiting*
Chicago, Illinois, 606576156
United States
Recruiting Rita Verheggen 773-244-5802
Northwestern Memorial Physicians *Recruiting*
Chicago, Illinois, 60657
United States
Recruiting Rita Verheggen 773-244-5802
Cobb-Douglas County Infectious Disease Clinic *Recruiting*
Atlanta, Georgia, 30308
United States
Recruiting Bentley Sweeton 404-876-2317
Treasure Coast Infectious Disease Consultants *Recruiting*
Vero Beach, Florida, 32960
United States
Recruiting Jeffrey Mieras 772-978-9556
Our Lady of the Lake Regional Med Ctr *Recruiting*
New Orleans, Louisiana, 701122699
United States
Recruiting Janice Walker 504-584-1971
Cooper Hospital Early Intervention Program *Recruiting*
Camden, New Jersey, 08103
United States
Recruiting Pamela Gorman 856-963-6890
Burwood Street General Pratice *Recruiting*
Burwood NSW, , 2134
Australia
Recruiting Jeff Hudson (+61) 2 9745 2755
Hospital de Clinicas Jose de San Martin *Recruiting*
Buenos Aires, ,
Argentina
Recruiting Roberta Maria Lattes 01-5411-4508-3991
Community Consortium / UCSF *Recruiting*
San Francisco, California, 94110
United States
Recruiting Carroll Child 415-476-9554
Community Research Initiative/ProACT *Recruiting*
Springfield, Massachusetts, 01107
United States
Recruiting Sandy Sheble-Hall 617-778-5454
Vernon J. Harris East End Community Health Care Ct *Recruiting*
Richmond, Virginia, 23298
United States
Recruiting Martha Howe 804-828-6471
Wellington Hosp *Recruiting*
Wellington, ,
New Zealand
Recruiting Timothy Blackmore 0011 64 4 385 5999
Additional Information:
Study ID Numbers: CPCRA 065; SMART
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027352
Other Hiv Infections Studies:
1. A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children
2. A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection
3. Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination with Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects
4. Effects of BufferGel and PRO 2000/5 Gel in Men
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Related Studies:
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A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)
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