Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
297 participants
OBSERVATIONAL
2005-03-31
2007-07-31
Brief Summary
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Detailed Description
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This trial is a substudy of a study of management of antiretroviral therapy (SMART). In the SMART study, patients will participate in one of two strategies: a drug conservation (DC) strategy and a viral suppression (VS) strategy. Participants in the DC group will stop or defer HAART, then receive episodic HAART treatment for the minimum time needed to maintain a CD4 cell count of at least 250 cells/mm3. Participants in the VS group will receive HAART to maintain a viral load as low as possible, regardless of CD4 count. The purpose of this study is to compare changes in neurocognitive functioning and peripheral neuropathy symptoms between the 2 strategies of the SMART study.
Patients will participate in this substudy and the main SMART study at the same time. Within 45 days prior to randomization into the main SMART study, participants will have baseline data collected for this substudy. This data will include peripheral neuropathy assessments, treatments for symptoms of peripheral neuropathy. At selected study sites, additional measures will assess neurocognitive function, depression, alcohol and drug use, and education. At 6 months, 12 months, and every 12 months thereafter, peripheral neuropathy symptoms and treatment for the symptoms will be assessed; a pain questionnaire will also be completed. Participants will be followed until the SMART study ends.
Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Edwina Wright, MBBS, FRACP
Role: STUDY_CHAIR
Infectious Disease Unit, the Alfred Hospital
Locations
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Castro-Mission Health Ctr. CRS
San Francisco, California, United States
Kaiser Permanente of Denver CRS
Denver, Colorado, United States
Univ. of Colorado Health Science Ctr. CRS
Denver, Colorado, United States
Denver Public Health CRS
Denver, Colorado, United States
Eastside Family Health Ctr. CRS
Denver, Colorado, United States
Western Infectious Disease Consultants CRS
Wheat Ridge, Colorado, United States
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
Washington D.C., District of Columbia, United States
Univ. of Florida, Div. of Infectious Diseases CRS
Jacksonville, Florida, United States
Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS
Baton Rouge, Louisiana, United States
Wayne State Univ. CRS
Detroit, Michigan, United States
Henry Ford Hosp. CRS
Detroit, Michigan, United States
Michigan State Univ., Infectious Disease Clinic CRS
Lansing, Michigan, United States
SUNY Downstate Med. Ctr., HIV Ctr. for Women & Children CRS
Brooklyn, New York, United States
Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
New York, New York, United States
Bronx-Lebanon Hosp. Ctr. CRS
The Bronx, New York, United States
Jacobi Med. Ctr., Ambulatory Care Pavillion CRS
The Bronx, New York, United States
Montefiore Med. Ctr., AIDS Ctr. CRS
The Bronx, New York, United States
Bronx VAMC CRS
The Bronx, New York, United States
Univ. of Oklahoma Health Sciences Ctr., Div. of Infectious Diseases CRS
Oklahoma City, Oklahoma, United States
The Research & Education Group-Portland CRS
Portland, Oregon, United States
Kaiser Immune Deficiency Clinic of Portland CRS
Portland, Oregon, United States
Legacy Clinic Emanuel CRS
Portland, Oregon, United States
Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
Portland, Oregon, United States
Temple Univ. School of Medicine CRS
Philadelphia, Pennsylvania, United States
MediCorp, Infectious Disease Associates CRS
Fredericksburg, Virginia, United States
Vernon Harris East End Community Health Ctr. CRS
Richmond, Virginia, United States
CrossOver Health Ctr. CRS
Richmond, Virginia, United States
VCU Health Systems, Infectious Disease Clinic CRS
Richmond, Virginia, United States
Virginia Commonwealth Univ. Medical Ctr. CRS
Richmond, Virginia, United States
Med. College of Wisconsin, Infectious Disease Clinic CRS
Milwaukee, Wisconsin, United States
Burwood Road Gen. Practice CRS
Burwood, New South Wales, Australia
St. Vincent's Hospital CRS
Darlinghurst, New South Wales, Australia
Westmead Hospital CRS
Westmead, New South Wales, Australia
Melbourne Sexual Health Ctr. CRS
Carlton, Victoria, Australia
The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS
Melbourne, Victoria, Australia
Prahran Market Clinic CRS
Melbourne, Victoria, Australia
Hosp. Universitario Prof. Edgard SantosCRS
Salvador, Estado de Bahia, Brazil
Instituto de Infectologia Emilio Ribas CRS
São Paulo, , Brazil
Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS
Halifax, Nova Scotia, Canada
Windsor Regional Hosp., HIV Care Program CRS
Windsor, Ontario, 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, , Thailand
Countries
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References
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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.
Related Links
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Click here for information on CPCRA 065
Other Identifiers
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CPCRA 065F1
Identifier Type: -
Identifier Source: secondary_id
CPCRA 065
Identifier Type: -
Identifier Source: secondary_id
10115
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 065F
Identifier Type: -
Identifier Source: org_study_id
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