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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00432003
Registration number
NCT00432003
Ethics application status
Date submitted
5/02/2007
Date registered
6/02/2007
Date last updated
17/04/2014
Titles & IDs
Public title
Effects of Anti-HIV Therapy on Nervous System Function
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Scientific title
Neurology: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (SMART) to Determine the Impact of the Strategies Upon Central and Peripheral Nervous System Function
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Secondary ID [1]
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CPCRA 065F1
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Secondary ID [2]
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CPCRA 065F
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Infections
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Condition category
Condition code
Infection
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in QNPZ-5 scores
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Assessment method [1]
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Timepoint [1]
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Primary outcome [2]
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time to development of symptomatic peripheral neuropathy
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Assessment method [2]
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Timepoint [2]
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Primary outcome [3]
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change in peripheral neuropathy symptoms
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [1]
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Time to neurocognitive impairment
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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time to development of ADC, stage 2 or greater
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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chage in peripheral neuropathy symptoms
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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time to development of asymptomatic or symptomatic peripheral neuropathy
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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time to resolution of symptomatic peripheral neuropathy
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Assessment method [5]
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Timepoint [5]
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Eligibility
Key inclusion criteria
* Coenrollment in the SMART study
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Unable to comply with all study requirements
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2007
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Sample size
Target
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Accrual to date
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Final
297
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Burwood Road Gen. Practice CRS - Burwood
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Recruitment hospital [2]
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St. Vincent's Hospital CRS - Darlinghurst
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Recruitment hospital [3]
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Westmead Hospital CRS - Westmead
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Recruitment hospital [4]
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Melbourne Sexual Health Ctr. CRS - Carlton,
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Recruitment hospital [5]
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The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS - Melbourne
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Recruitment hospital [6]
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Prahran Market Clinic CRS - Melbourne
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Recruitment postcode(s) [1]
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2134 - Burwood
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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- Carlton,
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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3181 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Colorado
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United States of America
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District of Columbia
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Florida
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United States of America
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Louisiana
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Michigan
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New York
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United States of America
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Oklahoma
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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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Virginia
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United States of America
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Wisconsin
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Brazil
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Bahia
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Country [14]
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Brazil
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Sao Paulo
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Canada
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Nova Scotia
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Canada
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State/province [16]
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Ontario
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Thailand
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State/province [17]
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Nonthaburi
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Thailand
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State/province [18]
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Ratchathewi
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Thailand
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State/province [19]
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Chiang Mai
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Country [20]
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Thailand
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State/province [20]
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Khon Kaen
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Funding & Sponsors
Primary sponsor type
Government body
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Name
National Institute of Allergy and Infectious Diseases (NIAID)
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to observe the way two different anti-HIV treatment strategies affect nerve and brain function in adults with HIV.
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Trial website
https://clinicaltrials.gov/study/NCT00432003
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Trial related presentations / publications
Antunes F. Central nervous system AIDS--related diseases. Acta Neurochir (Wien). 2004 Oct;146(10):1071-4. doi: 10.1007/s00701-004-0334-0. Morgello S, Estanislao L, Simpson D, Geraci A, DiRocco A, Gerits P, Ryan E, Yakoushina T, Khan S, Mahboob R, Naseer M, Dorfman D, Sharp V; Manhattan HIV Brain Bank. HIV-associated distal sensory polyneuropathy in the era of highly active antiretroviral therapy: the Manhattan HIV Brain Bank. Arch Neurol. 2004 Apr;61(4):546-51. doi: 10.1001/archneur.61.4.546. Sacktor N. The epidemiology of human immunodeficiency virus-associated neurological disease in the era of highly active antiretroviral therapy. J Neurovirol. 2002 Dec;8 Suppl 2:115-21. doi: 10.1080/13550280290101094. Verma S, Estanislao L, Simpson D. HIV-associated neuropathic pain: epidemiology, pathophysiology and management. CNS Drugs. 2005;19(4):325-34. doi: 10.2165/00023210-200519040-00005.
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Public notes
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Contacts
Principal investigator
Name
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Edwina Wright, MBBS, FRACP
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Address
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Infectious Disease Unit, the Alfred Hospital
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00432003
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