Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027352
Status:
COMPLETED
Last Update Posted:
2009-11-25
First Post:
2001-12-04
Brief Title:
A Comparison of Two Ways to Manage Anti-HIV Treatment The SMART Study
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Large Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy The SMART Study
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cellsmm3 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 cellsmm3 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
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 75 years The DC group will stop or defer ART until CD4 cell count declines to below 250 cellsmm3 they will then receive treatment to increase CD4 count to greater than 350 cellsmm3 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
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 75 years The DC group will stop or defer ART until CD4 cell count declines to below 250 cellsmm3 they will then receive treatment to increase CD4 count to greater than 350 cellsmm3 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SMART | None | None | None |