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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00867048




Registration number
NCT00867048
Ethics application status
Date submitted
20/03/2009
Date registered
20/03/2009
Date last updated
9/10/2018

Titles & IDs
Public title
Strategic Timing of Antiretroviral Treatment
Scientific title
Strategic Timing of AntiRetroviral Treatment
Secondary ID [1] 0 0
U01AI068641
Secondary ID [2] 0 0
0603M83587
Universal Trial Number (UTN)
Trial acronym
START
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - All licensed antiretroviral medications

Experimental: Early ART - Initiate ART immediately following randomization

Active Comparator: Deferred ART - Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops


Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite endpoint of AIDS, serious non-AIDS diagnoses, and all-cause mortality
Timepoint [1] 0 0
4.5 years
Secondary outcome [1] 0 0
Components of the composite primary outcome measure
Timepoint [1] 0 0
4.5 years
Secondary outcome [2] 0 0
Specific non-AIDS diagnoses
Timepoint [2] 0 0
4.5 years
Secondary outcome [3] 0 0
Adverse events
Timepoint [3] 0 0
4.5 years
Secondary outcome [4] 0 0
Hospitalization, health-care utilization, quality of life
Timepoint [4] 0 0
4.5 years
Secondary outcome [5] 0 0
HIV drug resistance and transmission risk behavior
Timepoint [5] 0 0
4.5 years
Secondary outcome [6] 0 0
Change in neurocognitive function (in a subset of participants)
Timepoint [6] 0 0
4.5 years
Secondary outcome [7] 0 0
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)
Timepoint [7] 0 0
Blood taken at study entry and stored in a central repository indefinitely
Secondary outcome [8] 0 0
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)
Timepoint [8] 0 0
Before randomization into START
Secondary outcome [9] 0 0
Large and small artery elasticity (in a subset of participants)
Timepoint [9] 0 0
4.5 years
Secondary outcome [10] 0 0
Rate of lung function decline (in a subset of participants)
Timepoint [10] 0 0
4.5 years
Secondary outcome [11] 0 0
Changes in bone mineral density (in a subset of participants)
Timepoint [11] 0 0
4.5 years

Eligibility
Key inclusion 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Burwood Road General Practice - Burwood
Recruitment hospital [2] 0 0
East Sydney Doctors - Darlinghurst
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [4] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [5] 0 0
Taylor Square Private Clinic - Darlinghurst
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment hospital [7] 0 0
Sexual Health and HIV Service - Clinic 2 - Brisbane
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [9] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [10] 0 0
Melbourne Sexual Health Centre - Melbourne
Recruitment hospital [11] 0 0
Prahran Market Clinic - Melbourne
Recruitment hospital [12] 0 0
Centre Clinic - St Kilda
Recruitment hospital [13] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2134 - Burwood
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4000 - Brisbane
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3053 - Melbourne
Recruitment postcode(s) [8] 0 0
3181 - Melbourne
Recruitment postcode(s) [9] 0 0
3182 - St Kilda
Recruitment postcode(s) [10] 0 0
6000 - Perth
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Other
Name
University of Minnesota - Clinical and Translational Science Institute
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Allergy and Infectious Diseases (NIAID)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Medical Research Council
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The Kirby Institute for Infection and Immunity in Society
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Washington D.C. Veterans Affairs Medical Center
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
German Federal Ministry of Education and Research
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
NEAT - European AIDS Treatment Network
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
National Health and Medical Research Council, Australia
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Government body
Name [10] 0 0
National Institutes of Health Clinical Center (CC)
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Government body
Name [11] 0 0
National Cancer Institute (NCI)
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Government body
Name [12] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
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Government body
Name [13] 0 0
National Institute of Mental Health (NIMH)
Address [13] 0 0
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Government body
Name [14] 0 0
National Institute of Neurological Disorders and Stroke (NINDS)
Address [14] 0 0
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Government body
Name [15] 0 0
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Address [15] 0 0
Country [15] 0 0
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Commercial sector/Industry
Name [16] 0 0
Abbott
Address [16] 0 0
Country [16] 0 0
Other collaborator category [17] 0 0
Commercial sector/Industry
Name [17] 0 0
Bristol-Myers Squibb
Address [17] 0 0
Country [17] 0 0
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Commercial sector/Industry
Name [18] 0 0
Gilead Sciences
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GlaxoSmithKline
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Commercial sector/Industry
Name [20] 0 0
Merck Sharp & Dohme Corp.
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Other collaborator category [21] 0 0
Commercial sector/Industry
Name [21] 0 0
Tibotec Pharmaceutical Limited
Address [21] 0 0
Country [21] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00867048
Trial related presentations / publications
Babiker AG, Emery S, Fätkenheuer G, Gordin FM, Grund B, Lundgren JD, Neaton JD, Pett SL, Phillips A, Touloumi G, Vjechaj MJ; INSIGHT START Study Group. Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study. Clin Trials. 2013;10(1 Suppl):S5-S36. doi: 10.1177/1740774512440342. Epub 2012 Apr 30.
Public notes

Contacts
Principal investigator
Name 0 0
James D Neaton, PhD
Address 0 0
University of Minnesota - Clinical and Translational Science Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications