What we might know when START's finished.
HIV infection (Research)
Antiviral agents (Dosage and administration)
Antiviral agents (Research)
Clinical trials (Management)
|Publication:||Name: Research Initiative/Treatment Action! Publisher: The Center for AIDS: Hope & Remembrance Project Audience: General; Professional Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2008 The Center for AIDS: Hope & Remembrance Project ISSN: 1520-8745|
|Issue:||Date: Fall, 2008 Source Volume: 13 Source Issue: 2|
|Topic:||Event Code: 310 Science & research; 200 Management dynamics Computer Subject: Company business management|
|Geographic:||Geographic Scope: United States Geographic Code: 1USA United States|
START, a randomized trial that plans to recruit 4000 antiretroviral-naive people, aims to determine whether starting treatment with more than 500 CD4 cells/[mm.sup.3] is superior to waiting until the count falls to 350 cells/[mm.sup.3] in a composite outcome including a serious AIDS diagnosis, a serious non-AIDS disease, or death from any cause.
START has three secondary objectives:
1. To compare early versus deferred antiretroviral therapy (ART) for each component of the primary composite outcome.
2. To compare early versus deferred ART for numerous other outcomes, including cardiovascular disease, non-AIDS malignancies, bacterial pneumonia, hospitalization, quality of life, HIV drug resistance, and HIV transmission risk behavior.
3. To compare early versus deferred ART for the composite outcome and other major clinical outcomes in subgroups determined by age, gender, race/ethnicity, risk factors for serious non-AIDS conditions, pretreatment CD4 count and viral load, geographic region, calendar date of enrollment, and regimen specified before randomization.
SMART will try to enroll at least 900 people in a pilot phase to demonstrate the feasibility of enrolling participants for such a trial. A definitive phase will expand enrollment to approximately 4000 people.
Inclusion and exclusion criteria
Major exclusion criteria include previous ART or interleukin 2 therapy; diagnosis of an AIDS disease (including esophageal candidiasis and chronic Herpes simplex infection); other indicators of HIV progression such as oral thrush, unexplained weight loss or unexplained fever; myocardial infarction or another cardiovascular event within 6 months of randomization; non-AIDS cancer within 6 months of randomization; dialysis within 6 months of randomization; history of decompensated liver disease; current imprisonment or compulsory detention for psychiatric or physical illness; and current pregnancy or breastfeeding.
Investigators must prescribe a first-line regimen designated as "preferred" in the US Department of Health and Human Services (DHHS) antiretroviral guidelines. Regimens may change during the trial if DHHS preferred regimens change.
At this point START has sites in the United States, France, and Germany. Sites in other countries may be added.
Planned substudies include studies of genomics, neurology, and informed consent procedures.
For more information
Detailed information on START procedures and sites is online at www.clinicaltrials.gov.
|Gale Copyright:||Copyright 2008 Gale, Cengage Learning. All rights reserved.|