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NCT00432003 Clinical Trial

Effects of Anti-HIV Therapy on Nervous System Function

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00432003
Other study ID # CPCRA 065F
Secondary ID CPCRA 065F1CPCRA
Status Completed
Phase N/A
First received February 5, 2007
Last updated April 16, 2014
Start date March 2005
Est. completion date July 2007

Study information
Verified date April 2014
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 297
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Coenrollment in the SMART study

Exclusion Criteria:

- Unable to comply with all study requirements

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Australia Burwood Road Gen. Practice CRS Burwood New South Wales
Australia Melbourne Sexual Health Ctr. CRS Carlton, Victoria
Australia St. Vincent's Hospital CRS Darlinghurst New South Wales
Australia Prahran Market Clinic CRS Melbourne Victoria
Australia The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS Melbourne Victoria
Australia Westmead Hospital CRS Westmead New South Wales
Brazil Hosp. Universitario Prof. Edgard SantosCRS Salvador Bahia
Brazil Instituto de Infectologia Emilio Ribas CRS Sao Paulo
Canada 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
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 Bamrasnaradura Institute CRS Muang Nonthaburi
United States Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS Baton Rouge Louisiana
United States Bronx VAMC CRS Bronx New York
United States Bronx-Lebanon Hosp. Ctr. CRS Bronx New York
United States Jacobi Med. Ctr., Ambulatory Care Pavillion CRS Bronx New York
United States Montefiore Med. Ctr., AIDS Ctr. CRS Bronx New York
United States SUNY Downstate Med. Ctr., HIV Ctr. for Women & Children CRS Brooklyn New York
United States Denver Public Health CRS Denver Colorado
United States Eastside Family Health Ctr. CRS Denver Colorado
United States Kaiser Permanente of Denver CRS Denver Colorado
United States Univ. of Colorado Health Science Ctr. CRS Denver Colorado
United States Henry Ford Hosp. CRS Detroit Michigan
United States Wayne State Univ. CRS Detroit Michigan
United States MediCorp, Infectious Disease Associates CRS Fredericksburg Virginia
United States Univ. of Florida, Div. of Infectious Diseases CRS Jacksonville Florida
United States Michigan State Univ., Infectious Disease Clinic CRS Lansing Michigan
United States Med. College of Wisconsin, Infectious Disease Clinic CRS Milwaukee Wisconsin
United States Harlem Hospital Ctr./Columbia University CRS (Gordin CTU) New York New York
United States Univ. of Oklahoma Health Sciences Ctr., Div. of Infectious Diseases CRS Oklahoma City Oklahoma
United States Temple Univ. School of Medicine CRS Philadelphia Pennsylvania
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 The Research & Education Group-Portland CRS Portland Oregon
United States CrossOver Health Ctr. CRS Richmond Virginia
United States VCU Health Systems, Infectious Disease Clinic CRS Richmond Virginia
United States Vernon Harris East End Community Health Ctr. CRS Richmond Virginia
United States Virginia Commonwealth Univ. Medical Ctr. CRS Richmond Virginia
United States Castro-Mission Health Ctr. CRS San Francisco California
United States Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS Washington District of Columbia
United States Western Infectious Disease Consultants CRS Wheat Ridge Colorado

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Thailand, 

References & Publications (4)

Antunes F. Central nervous system AIDS--related diseases. Acta Neurochir (Wien). 2004 Oct;146(10):1071-4. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Verma S, Estanislao L, Simpson D. HIV-associated neuropathic pain: epidemiology, pathophysiology and management. CNS Drugs. 2005;19(4):325-34. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in QNPZ-5 scores
Primary time to development of symptomatic peripheral neuropathy
Primary change in peripheral neuropathy symptoms
Secondary Time to neurocognitive impairment
Secondary time to development of ADC, stage 2 or greater
Secondary chage in peripheral neuropathy symptoms
Secondary time to development of asymptomatic or symptomatic peripheral neuropathy
Secondary time to resolution of symptomatic peripheral neuropathy
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