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
|Condition or disease|
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|
|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|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
- Change in QNPZ-5 scores
- time to development of symptomatic peripheral neuropathy
- change in peripheral neuropathy symptoms
- 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
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
Show 45 Study Locations
|Study Chair:||Edwina Wright, MBBS, FRACP||Infectious Disease Unit, the Alfred Hospital|