Effects of Anti-HIV Therapy on Nervous System Function
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
4 other identifiers
observational
297
5 countries
45
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2005
Typical duration for all trials
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 5, 2007
CompletedFirst Posted
Study publicly available on registry
February 6, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedApril 17, 2014
April 1, 2014
2.3 years
February 5, 2007
April 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in QNPZ-5 scores
time to development of symptomatic peripheral neuropathy
change in peripheral neuropathy symptoms
Secondary Outcomes (5)
Time to neurocognitive impairment
time to development of ADC, stage 2 or greater
chage in peripheral neuropathy symptoms
time to development of asymptomatic or symptomatic peripheral neuropathy
time to resolution of symptomatic peripheral neuropathy
Eligibility Criteria
You may qualify if:
- Coenrollment in the SMART study
You may not qualify if:
- Unable to comply with all study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Castro-Mission Health Ctr. CRS
San Francisco, California, 94114, United States
Kaiser Permanente of Denver CRS
Denver, Colorado, 80204-4507, United States
Univ. of Colorado Health Science Ctr. CRS
Denver, Colorado, 80204-4507, United States
Denver Public Health CRS
Denver, Colorado, 80204, United States
Eastside Family Health Ctr. CRS
Denver, Colorado, 80205, United States
Western Infectious Disease Consultants CRS
Wheat Ridge, Colorado, 80033, United States
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
Washington D.C., District of Columbia, 20422, United States
Univ. of Florida, Div. of Infectious Diseases CRS
Jacksonville, Florida, 32206, United States
Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS
Baton Rouge, Louisiana, 70805, United States
Wayne State Univ. CRS
Detroit, Michigan, 48201, United States
Henry Ford Hosp. CRS
Detroit, Michigan, 48202, United States
Michigan State Univ., Infectious Disease Clinic CRS
Lansing, Michigan, 48910, United States
SUNY Downstate Med. Ctr., HIV Ctr. for Women & Children CRS
Brooklyn, New York, 11203, United States
Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
New York, New York, 10037-1802, United States
Bronx-Lebanon Hosp. Ctr. CRS
The Bronx, New York, 10457, United States
Jacobi Med. Ctr., Ambulatory Care Pavillion CRS
The Bronx, New York, 10461, United States
Montefiore Med. Ctr., AIDS Ctr. CRS
The Bronx, New York, 10467, United States
Bronx VAMC CRS
The Bronx, New York, 10468, United States
Univ. of Oklahoma Health Sciences Ctr., Div. of Infectious Diseases CRS
Oklahoma City, Oklahoma, 73104, United States
The Research & Education Group-Portland CRS
Portland, Oregon, 97210, United States
Kaiser Immune Deficiency Clinic of Portland CRS
Portland, Oregon, 97227, United States
Legacy Clinic Emanuel CRS
Portland, Oregon, 97227, United States
Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
Portland, Oregon, 97239, United States
Temple Univ. School of Medicine CRS
Philadelphia, Pennsylvania, 19140, United States
MediCorp, Infectious Disease Associates CRS
Fredericksburg, Virginia, 22401, United States
Vernon Harris East End Community Health Ctr. CRS
Richmond, Virginia, 23223, United States
CrossOver Health Ctr. CRS
Richmond, Virginia, 23224, United States
VCU Health Systems, Infectious Disease Clinic CRS
Richmond, Virginia, 23298, United States
Virginia Commonwealth Univ. Medical Ctr. CRS
Richmond, Virginia, 23298, United States
Med. College of Wisconsin, Infectious Disease Clinic CRS
Milwaukee, Wisconsin, 53226, United States
Burwood Road Gen. Practice CRS
Burwood, New South Wales, 2134, Australia
St. Vincent's Hospital CRS
Darlinghurst, New South Wales, 2010, Australia
Westmead Hospital CRS
Westmead, New South Wales, 2145, Australia
Melbourne Sexual Health Ctr. CRS
Carlton, Victoria, Australia
The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS
Melbourne, Victoria, 3004, Australia
Prahran Market Clinic CRS
Melbourne, Victoria, 3181, Australia
Hosp. Universitario Prof. Edgard SantosCRS
Salvador, Estado de Bahia, 40110-160, Brazil
Instituto de Infectologia Emilio Ribas CRS
São Paulo, 01246-900, Brazil
Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS
Halifax, Nova Scotia, B3H 2Y9, Canada
Windsor Regional Hosp., HIV Care Program CRS
Windsor, Ontario, N8W 1E3, Canada
Bamrasnaradura Institute CRS
Muang, Changwat Nonthaburi, Thailand
Chulalongkorn University Hospital CRS
Bangkok, Ratchathewi, Thailand
Mahidol Univ., Ramathibodi Hosp., Div of Infectious Disease CRS
Bangkok, Ratchathewi, Thailand
Sanpatong Hosp. CRS
Chiang Mai, Thailand
Khon Kaen Univ., Srinagarind Hosp., Div. of Infectious Diseases & Tropical Medicine, Dept. of Medici
Khon Kaen, 40002, Thailand
Related Publications (4)
Antunes F. Central nervous system AIDS--related diseases. Acta Neurochir (Wien). 2004 Oct;146(10):1071-4. doi: 10.1007/s00701-004-0334-0.
PMID: 15744843BACKGROUNDMorgello 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.
PMID: 15096404BACKGROUNDSacktor 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.
PMID: 12491162BACKGROUNDVerma 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.
PMID: 15813646BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Edwina Wright, MBBS, FRACP
Infectious Disease Unit, the Alfred Hospital
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2007
First Posted
February 6, 2007
Study Start
March 1, 2005
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
April 17, 2014
Record last verified: 2014-04