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| Descriptive Information Fields | |||||||||
| Brief Title † | A Comparison of Two Ways to Manage Anti-HIV Treatment (The SMART Study) | ||||||||
| Official Title † | A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study) | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Prospective | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | HIV Infections | ||||||||
| Intervention † | |||||||||
| MEDLINE PMIDs | 10889597, 10647802, 11071184, 12198623, 10716500 | ||||||||
| Links | Click here for the NIH News press release, "International HIV/AIDS Trial Finds Continuous Antiretroviral Therapy Superior to Episodic Therapy," 01/18/06  Haga clic aquí para ver información sobre este ensayo clínico en español. |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Terminated | ||||||||
| Enrollment † | 6000 | ||||||||
| Start Date † | |||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Note: Enrollment into this trial was halted 01/11/06. Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 13 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Estonia, France, Germany, Ireland, Israel, Italy, Japan, Lithuania, Luxembourg, Martinique, New Zealand, Norway, Peru, Poland, Puerto Rico, Spain, Switzerland, Thailand, United Kingdom | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00027352 | ||||||||
| Organization ID | CPCRA 065 | ||||||||
| Secondary IDs †† | SMART | ||||||||
| Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | July 2006 | ||||||||
| First Received Date † | December 4, 2001 | ||||||||
| Last Updated Date | January 10, 2008 | ||||||||
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