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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
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
Secondary ID [1] 0 0
CPCRA 065F1
Secondary ID [2] 0 0
CPCRA 065F
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in QNPZ-5 scores
Timepoint [1] 0 0
Primary outcome [2] 0 0
time to development of symptomatic peripheral neuropathy
Timepoint [2] 0 0
Primary outcome [3] 0 0
change in peripheral neuropathy symptoms
Timepoint [3] 0 0
Secondary outcome [1] 0 0
Time to neurocognitive impairment
Timepoint [1] 0 0
Secondary outcome [2] 0 0
time to development of ADC, stage 2 or greater
Timepoint [2] 0 0
Secondary outcome [3] 0 0
chage in peripheral neuropathy symptoms
Timepoint [3] 0 0
Secondary outcome [4] 0 0
time to development of asymptomatic or symptomatic peripheral neuropathy
Timepoint [4] 0 0
Secondary outcome [5] 0 0
time to resolution of symptomatic peripheral neuropathy
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
* Coenrollment in the SMART study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to comply with all study requirements

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2007
Sample size
Target
Accrual to date
Final
297
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Burwood Road Gen. Practice CRS - Burwood
Recruitment hospital [2] 0 0
St. Vincent's Hospital CRS - Darlinghurst
Recruitment hospital [3] 0 0
Westmead Hospital CRS - Westmead
Recruitment hospital [4] 0 0
Melbourne Sexual Health Ctr. CRS - Carlton,
Recruitment hospital [5] 0 0
The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS - Melbourne
Recruitment hospital [6] 0 0
Prahran Market Clinic CRS - Melbourne
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
- Carlton,
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
3181 - Melbourne
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
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Brazil
State/province [13] 0 0
Bahia
Country [14] 0 0
Brazil
State/province [14] 0 0
Sao Paulo
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Thailand
State/province [17] 0 0
Nonthaburi
Country [18] 0 0
Thailand
State/province [18] 0 0
Ratchathewi
Country [19] 0 0
Thailand
State/province [19] 0 0
Chiang Mai
Country [20] 0 0
Thailand
State/province [20] 0 0
Khon Kaen

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00432003
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.
Public notes

Contacts
Principal investigator
Name 0 0
Edwina Wright, MBBS, FRACP
Address 0 0
Infectious Disease Unit, the Alfred Hospital
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00432003