Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432003
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
2007-02-05
Brief Title:
Effects of Anti-HIV Therapy on Nervous System Function
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 cognitivemotor 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 cellsmm3 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
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 cellsmm3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10115 | REGISTRY | DAIDS-ES | None |
| CPCRA 065F1 | None | None | None |
| CPCRA 065 | None | None | None |