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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00867048
Ethics application status
Date submitted
20/03/2009
Date registered
23/03/2009
Date last updated
4/03/2024

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
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
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
Assessment method [1] 0 0
Timepoint [1] 0 0
full follow-up, 9.3 years
Secondary outcome [1] 0 0
AIDs or AIDs Related Death
Assessment method [1] 0 0
participant count
Timepoint [1] 0 0
full follow-up, 9.3 years
Secondary outcome [2] 0 0
Specific Non-AIDS Diagnoses
Assessment method [2] 0 0
Timepoint [2] 0 0
full follow-up, 9.3 years
Secondary outcome [3] 0 0
Death, All-cause Mortality
Assessment method [3] 0 0
Count of participants
Timepoint [3] 0 0
full follow-up, 9.3 years
Secondary outcome [4] 0 0
Quality of Life- Mean Change From Baseline in a Visual Analog Scale (VAS) for Perceived Current Health
Assessment method [4] 0 0
Mean change from baseline of the VAS. This was a single data item where participants self-reported their perceived current state of health on a scale of 0-100 (0=worst possible and 100=best possible).
Timepoint [4] 0 0
4.5 years
Secondary outcome [5] 0 0
Transmission Risk Behavior Outcome 1
Assessment method [5] 0 0
Proportion of participants identifying as men who have sex with men (MSM) engaging in condomless sex with HIV serodifferent partners (CLS-D) at study month 12. Participant completed a self-reported questionnaire on transmission risk behavior during the "past two months" at the month 12 visit following randomization.
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Change in Neurocognitive Function (in a Subset of Participants)
Assessment method [6] 0 0
Mean change from baseline of the QNPZ-8 score. In the Neurology substudy of START, participants were administered a neuropsychological test battery of 8 tests (grooved peg board, finger tapping, Color Trails 1 and 2, Semantic Verbal Fluency, WAIS III Digit Symbol, HVLT-R Learning, HVLT-R Delayed Recall). Test scores were standardized to z-scores using baseline values as reference such that baseline values had a mean of 0 and standard deviation of 1. Test scores were standardized to z-scores using baseline values as reference such that baseline values had a mean of 0 and standard deviation of 1. Z-scores \> 0 indicate improvement over baseline levels. The quantitative neuropsychological performance z-score (QNPZ-8) was the mean of the z-scores across the the 8 tests. Analyses were by intention-to-treat principles.
Timepoint [6] 0 0
4.5 years
Secondary outcome [7] 0 0
Large Artery Elasticity (in a Subset of Participants)
Assessment method [7] 0 0
Mean change from baseline in large arterial elasticity. In the Arterial Elasticity substudy of START, participants had non-invasive measurements of radial artery blood pressure waveforms recorded at baseline, study months 4, 8, and 12, and then annually. Small arterial elasticity (SAE) and large arterial elasticity (LAE) were derived from analysis of the diastolic pulse waveform. Analyses were by intention-to-treat principles.
Timepoint [7] 0 0
4.5 years
Secondary outcome [8] 0 0
Rate of Lung Function Decline (in a Subset of Participants) Among
Assessment method [8] 0 0
Rate of lung function decline (slope of forced expiratory volume (FEV1)) over follow-up among self-reported smokers at study entry. In the pulmonary substudy of START, participants had post-bronchodilator spirometry measures collected at baseline and annually. Analyses were by intention-to-treat principles.
Timepoint [8] 0 0
4.5 years
Secondary outcome [9] 0 0
Changes in Bone Mineral Density (in a Subset of Participants) Measure 1
Assessment method [9] 0 0
Mean percent change from baseline in bone mineral density at the spine. In the bone mineral density (BMD) substudy of START, participants underwent dual-enery x-ray absorptionmetry (DXA) to measure BMD at the spine and hip at baseline and annually. Analyses were by intention-to-treat principles.
Timepoint [9] 0 0
4.5 years
Secondary outcome [10] 0 0
Transmission Risk Behavior Outcome 2
Assessment method [10] 0 0
Percentage of participants identifying as hetrosexual engaging in condomless sex with HIV serodifferent partners (CLS-D) at study month 12. Participant completed a self-reported questionnaire on transmission risk behavior during the "past two months" at the month 12 visit following randomization.
Timepoint [10] 0 0
12 month visit
Secondary outcome [11] 0 0
Small Artery Elasticity (in a Subset of Participants)
Assessment method [11] 0 0
Mean change from baseline in small arterial elasticity. In the Arterial Elasticity substudy of START, participants had non-invasive measurements of radial artery blood pressure waveforms recorded at baseline, study months 4, 8, and 12, and then annually. Small arterial elasticity (SAE) and large arterial elasticity (LAE) were derived from analysis of the diastolic pulse waveform. Analyses were by intention-to-treat principles.
Timepoint [11] 0 0
4.5 years
Secondary outcome [12] 0 0
Rate of Lung Function Decline (in a Subset of Participants) Among Non-smokers
Assessment method [12] 0 0
Rate of lung function decline (slope of forced expiratory volume (FEV1)) over follow-up among self-reported non-smokers at study entry. In the pulmonary substudy of START, participants had post-bronchodilator spirometry measures collected at baseline and annually. Analyses were by intention-to-treat principles.
Timepoint [12] 0 0
4.5 years
Secondary outcome [13] 0 0
Changes in Bone Mineral Density (in a Subset of Participants) Measure 2
Assessment method [13] 0 0
Mean percent change from baseline in bone mineral density at the spine. In the bone mineral density (BMD) substudy of START, participants underwent dual-enery x-ray absorptionmetry (DXA) to measure BMD at the spine and hip at baseline and annually. Analyses were by intention-to-treat principles.
Timepoint [13] 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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/07/2022
Sample size
Target
Accrual to date
Final
4688
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
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
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Connecticut
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District of Columbia
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Florida
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Illinois
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Louisiana
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Maryland
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Massachusetts
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Michigan
Country [11] 0 0
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Minnesota
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New Jersey
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United States of America
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Virginia
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Wisconsin
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Argentina
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Buenos Aires
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Santa Fe
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Cordoba
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Neuquen
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Vienna
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Athens
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Thessaloniki
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Maharashtra
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India
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Tamil Nadu
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Dublin
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Haifa
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Israel
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Tel Aviv
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MI
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Bamako
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FCT
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Durban
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Pretoria
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Madrid
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Terrassa
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Valencia
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Vigo
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Malmo
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Basel
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Geneva
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Zurich
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Thailand
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Bangkok Noi
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Chiang Rai
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Thailand
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Chon Buri
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Thailand
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Khon Kaen
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Thailand
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Nonthaburi
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Uganda
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Entebbe
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Uganda
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Kampala
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United Kingdom
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Berkshire
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United Kingdom
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Cleveland
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Dorset
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Gloucester
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London
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Manchester

Funding & Sponsors
Primary sponsor type
Other
Name
University of Minnesota
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Allergy and Infectious Diseases (NIAID)
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Copenhagen HIV Programme (CHIP) -- Copenhagen, Denmark
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Medical Research Council
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
Kirby Institute
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Washington D.C. Veterans Affairs Medical Center
Country [5] 0 0
Other collaborator category [6] 0 0
Government body
Name [6] 0 0
ANRS, Emerging Infectious Diseases
Country [6] 0 0
Other collaborator category [7] 0 0
Government body
Name [7] 0 0
German Federal Ministry of Education and Research
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
NEAT - European AIDS Treatment Network
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
National Health and Medical Research Council, Australia
Country [9] 0 0
Other collaborator category [10] 0 0
Government body
Name [10] 0 0
National Institutes of Health Clinical Center (CC)
Country [10] 0 0
Other collaborator category [11] 0 0
Government body
Name [11] 0 0
National Cancer Institute (NCI)
Country [11] 0 0
Other collaborator category [12] 0 0
Government body
Name [12] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Country [12] 0 0
Other collaborator category [13] 0 0
Government body
Name [13] 0 0
National Institute of Mental Health (NIMH)
Country [13] 0 0
Other collaborator category [14] 0 0
Government body
Name [14] 0 0
National Institute of Neurological Disorders and Stroke (NINDS)
Country [14] 0 0
Other collaborator category [15] 0 0
Government body
Name [15] 0 0
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Country [15] 0 0
Other collaborator category [16] 0 0
Commercial sector/industry
Name [16] 0 0
Abbott
Country [16] 0 0
Other collaborator category [17] 0 0
Commercial sector/industry
Name [17] 0 0
Bristol-Myers Squibb
Country [17] 0 0
Other collaborator category [18] 0 0
Commercial sector/industry
Name [18] 0 0
Gilead Sciences
Country [18] 0 0
Other collaborator category [19] 0 0
Commercial sector/industry
Name [19] 0 0
GlaxoSmithKline
Country [19] 0 0
Other collaborator category [20] 0 0
Commercial sector/industry
Name [20] 0 0
Merck Sharp & Dohme LLC
Country [20] 0 0
Other collaborator category [21] 0 0
Commercial sector/industry
Name [21] 0 0
Tibotec Pharmaceutical Limited
Country [21] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James D Neaton, PhD
Address 0 0
University of Minnesota
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal INSIGHT START Study Group; Lundgren JD, Babiker AG... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00867048