AzTrials
AzTrials

HIV InfectionsNCT00432003

Effects of Anti-HIV Therapy on Nervous System Function

An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 45 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
How many people
297 participants
Where
45 sitesin 5 countries
Study dates
Mar 2005to Jul 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Coenrollment in the SMART study

Who cannot join

  • Unable to comply with all study requirements

Trial locations and contacts

45 sites in 5 countries.

45 sites in 5 countries

United States30 sites

  • Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS

    Baton Rouge, Louisiana, 70805

  • SUNY Downstate Med. Ctr., HIV Ctr. for Women & Children CRS

    Brooklyn, New York, 11203

  • Kaiser Permanente of Denver CRS

    Denver, Colorado, 80204-4507

  • Univ. of Colorado Health Science Ctr. CRS

    Denver, Colorado, 80204-4507

  • Denver Public Health CRS

    Denver, Colorado, 80204

  • Eastside Family Health Ctr. CRS

    Denver, Colorado, 80205

  • Wayne State Univ. CRS

    Detroit, Michigan, 48201

  • Henry Ford Hosp. CRS

    Detroit, Michigan, 48202

  • MediCorp, Infectious Disease Associates CRS

    Fredericksburg, Virginia, 22401

  • Univ. of Florida, Div. of Infectious Diseases CRS

    Jacksonville, Florida, 32206

  • Michigan State Univ., Infectious Disease Clinic CRS

    Lansing, Michigan, 48910

  • Med. College of Wisconsin, Infectious Disease Clinic CRS

    Milwaukee, Wisconsin, 53226

  • Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)

    New York, New York, 10037-1802

  • Univ. of Oklahoma Health Sciences Ctr., Div. of Infectious Diseases CRS

    Oklahoma City, Oklahoma, 73104

  • Temple Univ. School of Medicine CRS

    Philadelphia, Pennsylvania, 19140

  • The Research & Education Group-Portland CRS

    Portland, Oregon, 97210

  • Kaiser Immune Deficiency Clinic of Portland CRS

    Portland, Oregon, 97227

  • Legacy Clinic Emanuel CRS

    Portland, Oregon, 97227

  • Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS

    Portland, Oregon, 97239

  • Vernon Harris East End Community Health Ctr. CRS

    Richmond, Virginia, 23223

  • CrossOver Health Ctr. CRS

    Richmond, Virginia, 23224

  • VCU Health Systems, Infectious Disease Clinic CRS

    Richmond, Virginia, 23298

  • Virginia Commonwealth Univ. Medical Ctr. CRS

    Richmond, Virginia, 23298

  • Castro-Mission Health Ctr. CRS

    San Francisco, California, 94114

  • Bronx-Lebanon Hosp. Ctr. CRS

    The Bronx, New York, 10457

  • Jacobi Med. Ctr., Ambulatory Care Pavillion CRS

    The Bronx, New York, 10461

  • Montefiore Med. Ctr., AIDS Ctr. CRS

    The Bronx, New York, 10467

  • Bronx VAMC CRS

    The Bronx, New York, 10468

  • Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS

    Washington D.C., District of Columbia, 20422

  • Western Infectious Disease Consultants CRS

    Wheat Ridge, Colorado, 80033

Other trials in United States

Australia6 sites

  • Burwood Road Gen. Practice CRS

    Burwood, New South Wales, 2134

  • Melbourne Sexual Health Ctr. CRS

    Carlton, Victoria

  • St. Vincent's Hospital CRS

    Darlinghurst, New South Wales, 2010

  • The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS

    Melbourne, Victoria, 3004

  • Prahran Market Clinic CRS

    Melbourne, Victoria, 3181

  • Westmead Hospital CRS

    Westmead, New South Wales, 2145

Other trials in Australia

Thailand5 sites

  • Chulalongkorn University Hospital CRS

    Bangkok, Ratchathewi

  • Mahidol Univ., Ramathibodi Hosp., Div of Infectious Disease CRS

    Bangkok, Ratchathewi

  • Sanpatong Hosp. CRS

    Chiang Mai

  • Khon Kaen Univ., Srinagarind Hosp., Div. of Infectious Diseases & Tropical Medicine, Dept. of Medici

    Khon Kaen, 40002

  • Bamrasnaradura Institute CRS

    Muang, Changwat Nonthaburi

Other trials in Thailand

Brazil2 sites

  • Hosp. Universitario Prof. Edgard SantosCRS

    Salvador, Estado de Bahia, 40110-160

  • Instituto de Infectologia Emilio Ribas CRS

    São Paulo, 01246-900

Other trials in Brazil

Canada2 sites

  • Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS

    Halifax, Nova Scotia, B3H 2Y9

  • Windsor Regional Hosp., HIV Care Program CRS

    Windsor, Ontario, N8W 1E3

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
HIV Infections
Keywords
Treatment Experienced, HIV, Antiretroviral Therapy, Highly Active
Medical subject headings
HIV Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in QNPZ-5 scores

  2. time to development of symptomatic peripheral neuropathy

  3. change in peripheral neuropathy symptoms

Secondary outcomes (5)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2007 (estimated)
  2. Study startMar 2005
  3. Primary completionJul 2007
  4. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00432003
Sponsor's protocol ID
CPCRA 065F
Other IDs
CPCRA 065F1, CPCRA 065, 10115
Status last verified
Apr 2014
First submitted
5 Feb 2007
Last updated
17 Apr 2014
Results posted
No

Publications

  • Antunes F. Central nervous system AIDS--related diseases. Acta Neurochir (Wien). 2004 Oct;146(10):1071-4. doi: 10.1007/s00701-004-0334-0.

    PubMed 15744843

  • 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.

    PubMed 15096404

  • 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.

    PubMed 12491162

  • 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.

    PubMed 15813646

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 45 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Australia, Thailand, Brazil, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in QNPZ-5 scores. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00432003, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in