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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
Timepoint [1] 0 0
full follow-up, 9.3 years
Secondary outcome [1] 0 0
AIDs or AIDs Related Death
Timepoint [1] 0 0
full follow-up, 9.3 years
Secondary outcome [2] 0 0
Specific Non-AIDS Diagnoses
Timepoint [2] 0 0
full follow-up, 9.3 years
Secondary outcome [3] 0 0
Death, All-cause Mortality
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
Timepoint [4] 0 0
4.5 years
Secondary outcome [5] 0 0
Transmission Risk Behavior Outcome 1
Timepoint [5] 0 0
12 months
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
Large Artery Elasticity (in a Subset of Participants)
Timepoint [7] 0 0
4.5 years
Secondary outcome [8] 0 0
Rate of Lung Function Decline (in a Subset of Participants) Among
Timepoint [8] 0 0
4.5 years
Secondary outcome [9] 0 0
Changes in Bone Mineral Density (in a Subset of Participants) Measure 1
Timepoint [9] 0 0
4.5 years
Secondary outcome [10] 0 0
Transmission Risk Behavior Outcome 2
Timepoint [10] 0 0
12 month visit
Secondary outcome [11] 0 0
Small Artery Elasticity (in a Subset of Participants)
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
Timepoint [12] 0 0
4.5 years
Secondary outcome [13] 0 0
Changes in Bone Mineral Density (in a Subset of Participants) Measure 2
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
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Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Cordoba
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Argentina
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Neuquen
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Austria
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Vienna
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Belgium
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Antwerp
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Brussels
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Ghent
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Belgium
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Leuven
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Brazil
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BA
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Brazil
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ES
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Brazil
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RJ
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Brazil
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SP
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Chile
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Santiago
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Czechia
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Plzen
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Czechia
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Prague
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Denmark
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Aarhus
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Denmark
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Copenhagen
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Denmark
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Hvidovre
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Denmark
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Odense
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Estonia
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Tallinn
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Finland
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Helsinki
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France
State/province [44] 0 0
Besancon
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France
State/province [45] 0 0
Caen
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France
State/province [46] 0 0
Clamart
Country [47] 0 0
France
State/province [47] 0 0
Creteil
Country [48] 0 0
France
State/province [48] 0 0
Le Kremlin-Bicetre
Country [49] 0 0
France
State/province [49] 0 0
Paris
Country [50] 0 0
France
State/province [50] 0 0
Suresnes
Country [51] 0 0
France
State/province [51] 0 0
Tourcoing
Country [52] 0 0
Germany
State/province [52] 0 0
Berlin
Country [53] 0 0
Germany
State/province [53] 0 0
Bonn
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Germany
State/province [54] 0 0
Cologne
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Germany
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Dortmund
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Germany
State/province [56] 0 0
Duesseldorf
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Germany
State/province [57] 0 0
Erlangen
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Germany
State/province [58] 0 0
Essen
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Germany
State/province [59] 0 0
Frankfurt
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Germany
State/province [60] 0 0
Hamburg
Country [61] 0 0
Germany
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Hanover
Country [62] 0 0
Germany
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Heidelberg
Country [63] 0 0
Germany
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Munich
Country [64] 0 0
Germany
State/province [64] 0 0
Regensburg
Country [65] 0 0
Germany
State/province [65] 0 0
Wuerzburg
Country [66] 0 0
Greece
State/province [66] 0 0
Athens
Country [67] 0 0
Greece
State/province [67] 0 0
Thessaloniki
Country [68] 0 0
India
State/province [68] 0 0
Maharashtra
Country [69] 0 0
India
State/province [69] 0 0
Tamil Nadu
Country [70] 0 0
Ireland
State/province [70] 0 0
Dublin
Country [71] 0 0
Israel
State/province [71] 0 0
Haifa
Country [72] 0 0
Israel
State/province [72] 0 0
Tel Aviv
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Italy
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MI
Country [74] 0 0
Italy
State/province [74] 0 0
RM
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Luxembourg
State/province [75] 0 0
Luxembourg
Country [76] 0 0
Malaysia
State/province [76] 0 0
Federal Territory
Country [77] 0 0
Mali
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Bamako
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Mexico
State/province [78] 0 0
Tlalpan
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Morocco
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Casablanca
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Nigeria
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FCT
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Norway
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Oslo
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Peru
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Lima
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Bialystok
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Warsaw
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Wroclaw
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Portugal
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Lisbon
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Portugal
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Oporto
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Puerto Rico
State/province [88] 0 0
Rio Piedras
Country [89] 0 0
Puerto Rico
State/province [89] 0 0
San Juan
Country [90] 0 0
South Africa
State/province [90] 0 0
Cape Town
Country [91] 0 0
South Africa
State/province [91] 0 0
Durban
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South Africa
State/province [92] 0 0
Johannesburg
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South Africa
State/province [93] 0 0
Pretoria
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Spain
State/province [94] 0 0
Alcala de Henares
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Spain
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Badalona
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Spain
State/province [96] 0 0
Barcelona
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Spain
State/province [97] 0 0
Madrid
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Spain
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Terrassa
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Spain
State/province [99] 0 0
Valencia
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Spain
State/province [100] 0 0
Vigo
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Sweden
State/province [101] 0 0
Gothenburg
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Sweden
State/province [102] 0 0
Malmo
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Switzerland
State/province [103] 0 0
Basel
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Switzerland
State/province [104] 0 0
Bern
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Switzerland
State/province [105] 0 0
Geneva
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Switzerland
State/province [106] 0 0
Zurich
Country [107] 0 0
Thailand
State/province [107] 0 0
Bangkok Noi
Country [108] 0 0
Thailand
State/province [108] 0 0
Bangkok
Country [109] 0 0
Thailand
State/province [109] 0 0
Chiang Mai
Country [110] 0 0
Thailand
State/province [110] 0 0
Chiang Rai
Country [111] 0 0
Thailand
State/province [111] 0 0
Chon Buri
Country [112] 0 0
Thailand
State/province [112] 0 0
Khon Kaen
Country [113] 0 0
Thailand
State/province [113] 0 0
Nonthaburi
Country [114] 0 0
Uganda
State/province [114] 0 0
Entebbe
Country [115] 0 0
Uganda
State/province [115] 0 0
Kampala
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Berkshire
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Cleveland
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Dorset
Country [119] 0 0
United Kingdom
State/province [119] 0 0
East Sussex
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Leicestershire
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Northern Ireland
Country [122] 0 0
United Kingdom
State/province [122] 0 0
South Yorkshire
Country [123] 0 0
United Kingdom
State/province [123] 0 0
West Midlands
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Bristol
Country [125] 0 0
United Kingdom
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Gloucester
Country [126] 0 0
United Kingdom
State/province [126] 0 0
London
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Other
Name
University of Minnesota
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
Government body
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
Government body
Name [6] 0 0
ANRS, Emerging Infectious Diseases
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Government body
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)
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Government body
Name [11] 0 0
National Cancer Institute (NCI)
Address [11] 0 0
Country [11] 0 0
Other collaborator category [12] 0 0
Government body
Name [12] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [12] 0 0
Country [12] 0 0
Other collaborator category [13] 0 0
Government body
Name [13] 0 0
National Institute of Mental Health (NIMH)
Address [13] 0 0
Country [13] 0 0
Other collaborator category [14] 0 0
Government body
Name [14] 0 0
National Institute of Neurological Disorders and Stroke (NINDS)
Address [14] 0 0
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)
Address [15] 0 0
Country [15] 0 0
Other collaborator category [16] 0 0
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
Other collaborator category [18] 0 0
Commercial sector/industry
Name [18] 0 0
Gilead Sciences
Address [18] 0 0
Country [18] 0 0
Other collaborator category [19] 0 0
Commercial sector/industry
Name [19] 0 0
GlaxoSmithKline
Address [19] 0 0
Country [19] 0 0
Other collaborator category [20] 0 0
Commercial sector/industry
Name [20] 0 0
Merck Sharp & Dohme LLC
Address [20] 0 0
Country [20] 0 0
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
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
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol, Statistical Analysis Plan, and Inf... [More Details] https://cdn.clinicaltrials.gov/large-docs/48/NCT00867048/Prot_SAP_ICF_000.pdf
Statistical analysis plan Study Protocol, Statistical Analysis Plan, and Inf... [More Details] https://cdn.clinicaltrials.gov/large-docs/48/NCT00867048/Prot_SAP_ICF_000.pdf
Informed consent form Study Protocol, Statistical Analysis Plan, and Inf... [More Details] https://cdn.clinicaltrials.gov/large-docs/48/NCT00867048/Prot_SAP_ICF_000.pdf
Study protocol Study Protocol, Statistical Analysis Plan, and Inf... [More Details] https://cdn.clinicaltrials.gov/large-docs/48/NCT00867048/Prot_SAP_ICF_000.pdf
Statistical analysis plan Study Protocol, Statistical Analysis Plan, and Inf... [More Details] https://cdn.clinicaltrials.gov/large-docs/48/NCT00867048/Prot_SAP_ICF_000.pdf
Informed consent form Study Protocol, Statistical Analysis Plan, and Inf... [More Details] https://cdn.clinicaltrials.gov/large-docs/48/NCT00867048/Prot_SAP_ICF_000.pdf



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