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Effects of Anti-HIV Therapy on Nervous System Function

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ClinicalTrials.gov Identifier: NCT00432003
Recruitment Status : Completed
First Posted : February 6, 2007
Last Update Posted : April 17, 2014
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease
HIV Infections

Detailed Description:

AIDS dementia complex (ADC) is a condition characterized by cognitive impairment, psychomotor slowing, and behavioral change. A milder form of ADC, called HIV minor cognitive/motor disorder (MCMD), is characterized by similar symptoms but has less of an impact on daily functioning. The neurocognitive impairment that results from ADC and MCMD carries an increased risk of poor drug adherence, morbidity, and mortality. It is unclear if highly active antiretroviral therapy (HAART) is effective in preserving neurocognitive function or in preventing or treating neurocognitive impairment. Distal symmetric sensory polyneuropathy (DSPN) and nucleoside-related neuropathy are two other serious conditions that HIV patients are at high risk for. DSPN is thought to be caused by active HIV infection; nucleoside-related neuropathy is thought to be caused by mitochondrial toxicity related to the use of certain antiretrovirals. These 2 conditions may lead to severe pain and discomfort in the feet. It is unknown what connection, if any, there is between DSPN and nucleoside-related neuropathy and the use of HAART. More data are needed on the natural history of these conditions.

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.

Study Type : Observational
Actual Enrollment : 297 participants
Time Perspective: Prospective
Official 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
Study Start Date : March 2005
Primary Completion Date : July 2007
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Primary Outcome Measures :
  1. Change in QNPZ-5 scores
  2. time to development of symptomatic peripheral neuropathy
  3. change in peripheral neuropathy symptoms

Secondary Outcome Measures :
  1. Time to neurocognitive impairment
  2. time to development of ADC, stage 2 or greater
  3. chage in peripheral neuropathy symptoms
  4. time to development of asymptomatic or symptomatic peripheral neuropathy
  5. time to resolution of symptomatic peripheral neuropathy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Coenrollment in the SMART study

Exclusion Criteria:

  • Unable to comply with all study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432003

  Hide Study Locations
United States, California
Castro-Mission Health Ctr. CRS
San Francisco, California, United States, 94114
United States, Colorado
Kaiser Permanente of Denver CRS
Denver, Colorado, United States, 80204-4507
Univ. of Colorado Health Science Ctr. CRS
Denver, Colorado, United States, 80204-4507
Denver Public Health CRS
Denver, Colorado, United States, 80204
Eastside Family Health Ctr. CRS
Denver, Colorado, United States, 80205
Western Infectious Disease Consultants CRS
Wheat Ridge, Colorado, United States, 80033
United States, District of Columbia
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
Washington, District of Columbia, United States, 20422
United States, Florida
Univ. of Florida, Div. of Infectious Diseases CRS
Jacksonville, Florida, United States, 32206
United States, Louisiana
Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS
Baton Rouge, Louisiana, United States, 70805
United States, Michigan
Wayne State Univ. CRS
Detroit, Michigan, United States, 48201
Henry Ford Hosp. CRS
Detroit, Michigan, United States, 48202
Michigan State Univ., Infectious Disease Clinic CRS
Lansing, Michigan, United States, 48910
United States, New York
Bronx-Lebanon Hosp. Ctr. CRS
Bronx, New York, United States, 10457
Jacobi Med. Ctr., Ambulatory Care Pavillion CRS
Bronx, New York, United States, 10461
Montefiore Med. Ctr., AIDS Ctr. CRS
Bronx, New York, United States, 10467
Bronx, New York, United States, 10468
SUNY Downstate Med. Ctr., HIV Ctr. for Women & Children CRS
Brooklyn, New York, United States, 11203
Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
New York, New York, United States, 10037-1802
United States, Oklahoma
Univ. of Oklahoma Health Sciences Ctr., Div. of Infectious Diseases CRS
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
The Research & Education Group-Portland CRS
Portland, Oregon, United States, 97210
Kaiser Immune Deficiency Clinic of Portland CRS
Portland, Oregon, United States, 97227
Legacy Clinic Emanuel CRS
Portland, Oregon, United States, 97227
Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
Portland, Oregon, United States, 97239
United States, Pennsylvania
Temple Univ. School of Medicine CRS
Philadelphia, Pennsylvania, United States, 19140
United States, Virginia
MediCorp, Infectious Disease Associates CRS
Fredericksburg, Virginia, United States, 22401
Vernon Harris East End Community Health Ctr. CRS
Richmond, Virginia, United States, 23223
CrossOver Health Ctr. CRS
Richmond, Virginia, United States, 23224
VCU Health Systems, Infectious Disease Clinic CRS
Richmond, Virginia, United States, 23298
Virginia Commonwealth Univ. Medical Ctr. CRS
Richmond, Virginia, United States, 23298
United States, Wisconsin
Med. College of Wisconsin, Infectious Disease Clinic CRS
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Burwood Road Gen. Practice CRS
Burwood, New South Wales, Australia, 2134
St. Vincent's Hospital CRS
Darlinghurst, New South Wales, Australia, 2010
Westmead Hospital CRS
Westmead, New South Wales, Australia, 2145
Australia, Victoria
Melbourne Sexual Health Ctr. CRS
Carlton,, Victoria, Australia
The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS
Melbourne, Victoria, Australia, 3004
Prahran Market Clinic CRS
Melbourne, Victoria, Australia, 3181
Hosp. Universitario Prof. Edgard SantosCRS
Salvador, Bahia, Brazil, 40110-160
Instituto de Infectologia Emilio Ribas CRS
Sao Paulo, Brazil, 01246-900
Canada, Nova Scotia
Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Windsor Regional Hosp., HIV Care Program CRS
Windsor, Ontario, Canada, N8W 1E3
Bamrasnaradura Institute CRS
Muang, 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, 40002
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Edwina Wright, MBBS, FRACP Infectious Disease Unit, the Alfred Hospital

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00432003     History of Changes
Other Study ID Numbers: CPCRA 065F
10115 ( Registry Identifier: DAIDS-ES )
First Posted: February 6, 2007    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced
Antiretroviral Therapy, Highly Active

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases