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Strategic Timing of AntiRetroviral Treatment

Phase 4
18 Years
Open (Enrolling)
HIV Infection

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Trial Information

Strategic Timing of AntiRetroviral Treatment


- Most guidelines agree that if the number of your CD4+ cells (cells in your blood which
help fight infection) drops below 350 cells/mm3, or if you have symptoms of AIDS, you
should start taking HIV medicines. There are randomized trials that support this
recommendation. (Randomized trials are usually considered the strongest form of
evidence to support treatment decisions. Other studies, like observational studies,
provide evidence too, but the evidence is often considered to be weaker than evidence
from randomized trials. A randomized trial gives the most certain information about
how well a treatment works because randomization makes sure each group is similar
except for the treatment they receive.) Some experts believe that HIV treatment should
be started even when the number of CD4+ cells is above 350 cells/mm3. For example,
guidelines issued in the US in December 2009 include a new recommendation for starting
HIV medicines if your CD4+ cell count is between 350 and 500 cells/mm3. However, this
recommendation is based on information from observational studies, not randomized
trials. We are doing this study to find out if the chances of getting a serious
illness or of getting AIDS are less if people start taking HIV medicines at a time when
their CD4+ cell counts are still fairly high, instead of waiting to take HIV medicines
at a CD4+ count where there is good evidence for starting medicines.


- To find out if the chance of developing a serious illness or of getting AIDS is less if
patients start taking HIV medicines at a time when their CD4+ cell count is still
fairly high, instead of waiting until the CD4+ count is at the level where there is
good evidence for starting medicines.

- To learn more about how a strategy of starting HIV medicines early might affect other
aspects of care, such as the chances of developing other illnesses or resistance to HIV
medicines, the frequency of doctor visits, the cost of medical care, and general health
and satisfaction.


- Patients 18 years of age and older who are infected with HIV, have CD4+ cell counts of
greater than 500 cells/mm3, and who have never had antiretroviral therapy to treat HIV.


- Initial screening visits (2) to draw blood for CD4+ cell counts and provide a full
medical history

- Patients will be randomly split into two groups:

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.

- HIV medications for each patient will be determined by the study doctors.

- Evaluations during the treatment period:

- Physical examination, including vital signs and body weight checks, and pregnancy test
for women who can become pregnant.

- Questions about daily life, including sexual behaviors.

- Blood and urine tests.

- Heart tests with electrocardiogram.

- Patients will return for evaluations at 1 and 4 months after randomization, and every 4
months thereafter for the duration of the study.

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.

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

- The term licensed refers to an FDA-approved kit or, for sites located in
countries other than the United States, a kit that has been certified or
licensed by an oversight body within that country. Confirmation of the initial
test result must use a test method that is different than the one used for the
initial assessment.


- Any previous use of ART or interleukin-2 (IL-2)

- Diagnosis of any clinical AIDS event before randomization (including esophageal
candidiasis and chronic Herpes simplex infection)

- Presence of HIV progression such as oral thrush, unexplained weight loss, or
unexplained fever

- Cardiovascular event (myocardial infarction, angioplasty, coronary-artery bypass
grafting, stroke) within 6 months before randomization

- Non-AIDS-defining cancer, excluding basal and squamous cell skin cancer, within 6
months before randomization

- Dialysis within 6 months before randomization

- Diagnosis of decompensated liver disease before randomization

- Current imprisonment, or compulsory detention (involuntary incarceration) for
treatment of a psychiatric or physical illness

- Current pregnancy or breastfeeding (a negative serum or urine pregnancy test is
required within 14 days before randomization for women of child-bearing potential)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Composite endpoint of AIDS, serious non-AIDS diagnoses, and all-cause mortality

Outcome Time Frame:

4.5 years

Safety Issue:


Principal Investigator

James D Neaton, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota - Clinical and Translational Science Institute


Argentina: Ministry of Health

Study ID:




Start Date:

March 2009

Completion Date:

December 2015

Related Keywords:

  • HIV Infection
  • highly active antiretroviral therapy (HAART)
  • CD4 Count
  • Early Intervention
  • HIV
  • HIV Infection
  • HIV Infections
  • treatment naive
  • HIV Infections
  • Acquired Immunodeficiency Syndrome



Treasure Coast Infectious Disease Consultants Vero Beach, Florida  32960
Mayo Clinic Rochester, Minnesota  55905
George Washington University Medical Center Washington, District of Columbia  20037
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Boston Medical Center Boston, Massachusetts  02118
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Cooper University Hospital Camden, New Jersey  08103
University of Illinois at Chicago Chicago, Illinois  60612
Montefiore Medical Center Bronx, New York  10467-2490
Tulane University Medical Center New Orleans, Louisiana  70112
Temple University Philadelphia, Pennsylvania  19140
Duke University Durham, North Carolina  27710
Georgetown University Washington, District of Columbia  20007-2197
Henry Ford Health System Detroit, Michigan  48202
Wayne State University Detroit, Michigan  48202
University of Florida, Jacksonville Jacksonville, Florida  32209
Texas Children's Hospital Houston, Texas  
University of Miami Miami, Florida  33136
Virginia Commonwealth University Richmond, Virginia  
Yale University School Of Medicine New Haven, Connecticut  06520
University of Southern California Los Angeles, California  90033
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
The Ohio State University Medical Center Columbus, Ohio  43210
VA Greater Los Angeles Healthcare System Los Angeles, California  90073
SUNY Stony Brook Stony Brook, New York  11733
Community Research Initiative of New England Springfield, Massachusetts  
Walter Reed National Military Medical Center Bethesda, Maryland  20889
Cornell CRS New York, New York  10011
Houston AIDS Research Team CRS Houston, Texas  77030
Naval Medical Center San Diego San Diego, California  92134
Orlando Immunology Center Orlando, Florida  32803
University of North Texas Health Science Center Fort Worth, Texas  76109
UCLA CARE-4-Families (LABAC CRS) Los Angeles, California  90095
UCSD Mother-Child-Adolescent Program San Diego, California  92103
Washington DC VA Medical Center Washington, District of Columbia  20422
University of Florida Health Services Center Jacksonville, Florida  32209
University of Miami Pediatric Immunology Miami, Florida  33136
Infectious Diseases Associates NW FL, PA Pensacola, Florida  32504
USF Health - HIV Clinical Research Unit Tampa, Florida  33602
Mt. Sinai Hospital Chicago, Illinois  60608
Lurie Children's Hospital Chicago, Illinois  60611-2605
National Institutes of Health Clinical Center Bethesda, Maryland  20892-1504
New Jersey Medical School Adult Clinical Research Center Newark, New Jersey  07103
Bronx-Lebanon Hospital Center Bronx, New York  10452
UNC AIDS Clinical Trials Unit Chapel Hill, North Carolina  27514
Regional Center for Infectious Disease Greensboro, North Carolina  27401-1209
Wake County Human Services Raleigh, North Carolina  27610
The Research and Education Group - Portland Portland, Oregon  97210
UT Southwestern Clinical Research Unit Dallas, Texas  75235
San Antonio Military Health System Fort Sam Houston, Texas  78234
Naval Medical Center Portsmouth Portsmouth, Virginia  23708
AIDS Resource Center of Wisconsin Milwaukee, Wisconsin  53203
Florida Department of Health in Orange County/Hug Me Orlando, Florida  32805
MMRF, Hennepin County Medical Center Minneapolis, Minnesota  55415