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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00027352 |
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Date of registration:
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04/12/2001 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study)
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Scientific title:
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A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study) |
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Date of first enrolment:
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December 2001 |
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Target sample size:
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6000 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00027352 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belgium
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Brazil
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Canada
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Estonia
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France
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Germany
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Ireland
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Israel
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Italy
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Japan
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Lithuania
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Luxembourg
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Martinique
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New Zealand
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Norway
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Peru
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Poland
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Puerto Rico
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Spain
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Switzerland
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Thailand
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United Kingdom
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United States
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Contacts
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Name:
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Wafaa El-Sadr, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Harlem AIDS Treatment Group, Harlem Hospital Center |
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Name:
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James Neaton, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CPCRA Statistcal and Data Management Center / CCBR |
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Key inclusion & exclusion criteria
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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
Age minimum:
13 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Secondary ID(s)
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SMART
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CPCRA 065
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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