Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00027352




Registration number
NCT00027352
Ethics application status
Date submitted
4/12/2001
Date registered
5/12/2001
Date last updated
25/11/2009

Titles & IDs
Public title
A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)
Scientific title
A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
Secondary ID [1] 0 0
SMART
Secondary ID [2] 0 0
CPCRA 065
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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



- 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
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Prahran Market Clinic - South Yarra
Recruitment hospital [3] 0 0
The Centre Clinic - South Yarra
Recruitment hospital [4] 0 0
Burwood Street General Pratice - Burwood Nsw
Recruitment hospital [5] 0 0
Royal Perth Hosp - Perth
Recruitment hospital [6] 0 0
Alfred Hosp - Prahan
Recruitment hospital [7] 0 0
Royal Prince Alfred Hospital - Prahan
Recruitment hospital [8] 0 0
National Centre in HIV Epidemiology and Clinical Research - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- South Yarra
Recruitment postcode(s) [3] 0 0
2134 - Burwood Nsw
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment postcode(s) [5] 0 0
- Prahan
Recruitment postcode(s) [6] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Cordoba
Country [26] 0 0
Argentina
State/province [26] 0 0
La Plata
Country [27] 0 0
Argentina
State/province [27] 0 0
Mendoza
Country [28] 0 0
Argentina
State/province [28] 0 0
Rosario
Country [29] 0 0
Austria
State/province [29] 0 0
Vienna
Country [30] 0 0
Belgium
State/province [30] 0 0
Antwerp
Country [31] 0 0
Belgium
State/province [31] 0 0
Liege
Country [32] 0 0
Brazil
State/province [32] 0 0
RJ
Country [33] 0 0
Brazil
State/province [33] 0 0
RS
Country [34] 0 0
Brazil
State/province [34] 0 0
S.p. Cep
Country [35] 0 0
Brazil
State/province [35] 0 0
Boqueirao-Santos
Country [36] 0 0
Brazil
State/province [36] 0 0
Porto Alegre-RS Cep
Country [37] 0 0
Brazil
State/province [37] 0 0
Rio de Janeiro
Country [38] 0 0
Brazil
State/province [38] 0 0
Salvador-BA
Country [39] 0 0
Brazil
State/province [39] 0 0
San Paulo
Country [40] 0 0
Brazil
State/province [40] 0 0
Sao Paulo
Country [41] 0 0
Canada
State/province [41] 0 0
British Columbia
Country [42] 0 0
Canada
State/province [42] 0 0
Nova Scotia
Country [43] 0 0
Canada
State/province [43] 0 0
Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
Estonia
State/province [45] 0 0
Tallinn
Country [46] 0 0
France
State/province [46] 0 0
Annecy
Country [47] 0 0
France
State/province [47] 0 0
Bordeaux
Country [48] 0 0
France
State/province [48] 0 0
Chu-grenoble
Country [49] 0 0
France
State/province [49] 0 0
Colombes
Country [50] 0 0
France
State/province [50] 0 0
Marseille
Country [51] 0 0
France
State/province [51] 0 0
Paris
Country [52] 0 0
Germany
State/province [52] 0 0
Essen
Country [53] 0 0
Germany
State/province [53] 0 0
Frankfort
Country [54] 0 0
Germany
State/province [54] 0 0
Heidelberg
Country [55] 0 0
Germany
State/province [55] 0 0
Zurich Ch-
Country [56] 0 0
Ireland
State/province [56] 0 0
Dublin 8
Country [57] 0 0
Israel
State/province [57] 0 0
Tel Aviv
Country [58] 0 0
Italy
State/province [58] 0 0
Antella-Firenze
Country [59] 0 0
Italy
State/province [59] 0 0
Asti
Country [60] 0 0
Italy
State/province [60] 0 0
Brescia
Country [61] 0 0
Italy
State/province [61] 0 0
Busto Arsizio (va)
Country [62] 0 0
Italy
State/province [62] 0 0
Modena
Country [63] 0 0
Italy
State/province [63] 0 0
Pavia
Country [64] 0 0
Italy
State/province [64] 0 0
Rome
Country [65] 0 0
Italy
State/province [65] 0 0
Torino
Country [66] 0 0
Italy
State/province [66] 0 0
Torrette Di Ancona
Country [67] 0 0
Italy
State/province [67] 0 0
Venice
Country [68] 0 0
Japan
State/province [68] 0 0
Tokyo
Country [69] 0 0
Lithuania
State/province [69] 0 0
Vilnius
Country [70] 0 0
Luxembourg
State/province [70] 0 0
Barble
Country [71] 0 0
Martinique
State/province [71] 0 0
Fort-de-france
Country [72] 0 0
New Zealand
State/province [72] 0 0
Christchurch
Country [73] 0 0
New Zealand
State/province [73] 0 0
Wellington
Country [74] 0 0
Norway
State/province [74] 0 0
Oslo
Country [75] 0 0
Peru
State/province [75] 0 0
Lima
Country [76] 0 0
Poland
State/province [76] 0 0
Koszarowa Str. 5
Country [77] 0 0
Puerto Rico
State/province [77] 0 0
Curitiba
Country [78] 0 0
Spain
State/province [78] 0 0
Barcelona
Country [79] 0 0
Spain
State/province [79] 0 0
Madrid
Country [80] 0 0
Spain
State/province [80] 0 0
Sevilla
Country [81] 0 0
Spain
State/province [81] 0 0
Terrassa
Country [82] 0 0
Spain
State/province [82] 0 0
Valencia
Country [83] 0 0
Switzerland
State/province [83] 0 0
Basel Ch
Country [84] 0 0
Switzerland
State/province [84] 0 0
Bern
Country [85] 0 0
Switzerland
State/province [85] 0 0
La Chaux-de-Fonds
Country [86] 0 0
Switzerland
State/province [86] 0 0
Lausanne
Country [87] 0 0
Switzerland
State/province [87] 0 0
Lugano
Country [88] 0 0
Thailand
State/province [88] 0 0
Chiang Mai
Country [89] 0 0
Thailand
State/province [89] 0 0
Nonthaburi 11000
Country [90] 0 0
United Kingdom
State/province [90] 0 0
England
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Belfast
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Birmingham
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Bristol
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Carshalton, Surrey
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Carshalton
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Essex
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Halifax
Country [98] 0 0
United Kingdom
State/province [98] 0 0
London
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Middlesbrough
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Middlesex
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Newcastle
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Sheffield
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Watford Wd

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00027352
Trial related presentations / publications
Lederman MM, Valdez H. Immune restoration with antiretroviral therapies: implications for clinical management. JAMA. 2000 Jul 12;284(2):223-8. doi: 10.1001/jama.284.2.223.
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.
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.
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. Erratum In: J Infect Dis 2002 Oct 15;186(8):1198.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Wafaa El-Sadr, MD, MPH
Address 0 0
Harlem AIDS Treatment Group, Harlem Hospital Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00027352