Effects of Anti-HIV Therapy on Nervous System Function

April 16, 2014 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

297

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Coenrollment in the SMART study

Exclusion Criteria:

  • Unable to comply with all study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in QNPZ-5 scores
time to development of symptomatic peripheral neuropathy
change in peripheral neuropathy symptoms

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Edwina Wright, MBBS, FRACP, Infectious Disease Unit, the Alfred Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 5, 2007

First Submitted That Met QC Criteria

February 5, 2007

First Posted (Estimate)

February 6, 2007

Study Record Updates

Last Update Posted (Estimate)

April 17, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPCRA 065F
  • CPCRA 065
  • CPCRA 065F1
  • 10115 (DAIDS-ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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