Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
Objectives:
Full description
Background:
Objectives:
Eligibility:
Design:
Early: Patients will begin receiving HIV medications from the start of the study.
Deferred: Patients will begin to take HIV medications when the CD4 drops below 350 cells/mm3, or they develop AIDS or other symptoms of HIV infection.
Substudies will take advantage of the START randomization to compare outcomes in people starting ART early vs. later.
The purpose of this randomized study is to determine whether immediate initiation of antiretroviral treatment (ART) is superior to deferral of ART until the CD4+ declines below 350 cells/mm(3) in terms of morbidity and mortality in HIV-1 (subsequently referred to as HIV) infected persons who are antiretroviral naive with a CD4+ count above 500 cells/mm(3).
The study will enroll an estimated 4,000 participants. Participants will be followed for at least 3 years after enrollment, to a common closing date.
Substudies will take advantage of the START randomization to compare outcomes in people starting ART early vs. later. These will measure outcomes that do not require the entire sample size of START to determine whether early ART is related to a difference in these outcomes over the course of the study.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Signed informed consent
HIV infection documented by a plasma HIV RNA viral load, rapid HIV test or any licensed* ELISA test; and confirmed by another test using a different method including but not limited to a rapid HIV test, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry.
Age greater than or equal to 18 years
Karnofsky performance score greater than or equal to 80 (an indication that the participant can perform normal activities)
Perceived life expectancy of at least 6 months
For women of child-bearing potential, willingness to use contraceptives as described in the product information of the ART drugs they are prescribed
Two CD4+ cell counts greater than 500 cells/mm(3) at least 2 weeks apart within 60 days before randomization
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
4,688 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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