Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Strategic Timing of Antiretroviral Treatment (START)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00867048
Recruitment Status : Completed
First Posted : March 23, 2009
Last Update Posted : March 9, 2023
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark
Medical Research Council
The Kirby Institute for Infection and Immunity in Society
Washington D.C. Veterans Affairs Medical Center
ANRS, Emerging Infectious Diseases
German Federal Ministry of Education and Research
NEAT - European AIDS Treatment Network
National Health and Medical Research Council, Australia
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Abbott
Bristol-Myers Squibb
Gilead Sciences
GlaxoSmithKline
Merck Sharp & Dohme LLC
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
University of Minnesota

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Objectives:

  • 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 cluster-of-differentiation-4 (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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: All licensed antiretroviral medications Phase 4

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4688 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Strategic Timing of AntiRetroviral Treatment
Actual Study Start Date : April 15, 2009
Actual Primary Completion Date : July 27, 2022
Actual Study Completion Date : July 27, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Early ART
Initiate ART immediately following randomization
 Drug: All licensed antiretroviral medications
In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
Active Comparator: Deferred ART
Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops
 Drug: All licensed antiretroviral medications
In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Composite endpoint of AIDS, serious non-AIDS diagnoses, and all-cause mortality [ Time Frame: 4.5 years ]

Secondary Outcome Measures :
  1. Components of the composite primary outcome measure [ Time Frame: 4.5 years ]
  2. Specific non-AIDS diagnoses [ Time Frame: 4.5 years ]
  3. Adverse events [ Time Frame: 4.5 years ]
  4. Hospitalization, health-care utilization, quality of life [ Time Frame: 4.5 years ]
  5. HIV drug resistance and transmission risk behavior [ Time Frame: 4.5 years ]
  6. Change in neurocognitive function (in a subset of participants) [ Time Frame: 4.5 years ]
  7. Obtain a whole blood sample from which DNA will be extracted to study validated genetic variants that determine the risk of the various primary and secondary outcomes assessed in START (in a subset of participants) [ Time Frame: Blood taken at study entry and stored in a central repository indefinitely ]
  8. Evaluate understanding of study information and satisfaction with the consent process among START participants, after receiving information from either a standard or a concise consent form (at a subset of sites) [ Time Frame: Before randomization into START ]
  9. Large and small artery elasticity (in a subset of participants) [ Time Frame: 4.5 years ]
  10. Rate of lung function decline (in a subset of participants) [ Time Frame: 4.5 years ]
  11. Changes in bone mineral density (in a subset of participants) [ Time Frame: 4.5 years ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

EXCLUSION CRITERIA:

  • 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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867048


Locations
Show Show 218 study locations
Sponsors and Collaborators
University of Minnesota
National Institute of Allergy and Infectious Diseases (NIAID)
Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark
Medical Research Council
The Kirby Institute for Infection and Immunity in Society
Washington D.C. Veterans Affairs Medical Center
ANRS, Emerging Infectious Diseases
German Federal Ministry of Education and Research
NEAT - European AIDS Treatment Network
National Health and Medical Research Council, Australia
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Abbott
Bristol-Myers Squibb
Gilead Sciences
GlaxoSmithKline
Merck Sharp & Dohme LLC
Tibotec Pharmaceutical Limited
Investigators
Layout table for investigator information
Principal Investigator: James D Neaton, PhD University of Minnesota
Study Chair: Abdel Babiker, PhD Medical Research Council Clinical Trials Unit, London
Study Chair: Jens Lundgren, MD, DMSc Copenhagen HIV Programme
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT00867048    
Obsolete Identifiers: NCT00821171
Other Study ID Numbers: 0603M83587
U01AI068641 ( U.S. NIH Grant/Contract )
2008-006439-12 ( EudraCT Number )
First Posted: March 23, 2009    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: March 2023
Keywords provided by University of Minnesota:
highly active antiretroviral therapy (HAART)
CD4 Count
Early Intervention
HIV
 HIV Infection
HIV Infections
treatment naive
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
HIV Infections
Acquired Immunodeficiency Syndrome
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents