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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
Trial website
Trial related presentations / publications
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

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