Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000738
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Randomized Double-Blind Placebo-Controlled Trial of Nimodipine for the Neurological Manifestations of HIV-1
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Trial of Nimodipine for the Neurological Manifestations of HIV-1
Status:
COMPLETED
Status Verified Date:
2021-10
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:
PRIMARY To assess the safety of nimodipine in the treatment of HIV-Associated Motor Cognitive Complex formerly AIDS dementia complex To assess the systemic or central nervous system toxicities eg rash headache gastrointestinal symptoms nausea dyspnea muscle pain or cramp acne of nimodipine
SECONDARY To assess the efficacy of nimodipine in stabilizing the progression of HIV-Associated Motor Cognitive Complex by improvement in neuropsychological test performance peripheral neuropathy or other neurologic manifestations
HIV-infected patients may develop a condition known as HIV-Associated Motor Cognitive Complex also known as AIDS dementia complex that causes damage to the nervous system particularly the brain and spinal cord Evidence exists that nimodipine protects nerve cells in culture from injury by HIV Although nimodipine has been used in patients with other neurological problems its safety and effectiveness in halting the progression of HIV-Associated Motor Cognitive Complex is not yet known
SECONDARY To assess the efficacy of nimodipine in stabilizing the progression of HIV-Associated Motor Cognitive Complex by improvement in neuropsychological test performance peripheral neuropathy or other neurologic manifestations
HIV-infected patients may develop a condition known as HIV-Associated Motor Cognitive Complex also known as AIDS dementia complex that causes damage to the nervous system particularly the brain and spinal cord Evidence exists that nimodipine protects nerve cells in culture from injury by HIV Although nimodipine has been used in patients with other neurological problems its safety and effectiveness in halting the progression of HIV-Associated Motor Cognitive Complex is not yet known
Detailed Description:
HIV-infected patients may develop a condition known as HIV-Associated Motor Cognitive Complex also known as AIDS dementia complex that causes damage to the nervous system particularly the brain and spinal cord Evidence exists that nimodipine protects nerve cells in culture from injury by HIV Although nimodipine has been used in patients with other neurological problems its safety and effectiveness in halting the progression of HIV-Associated Motor Cognitive Complex is not yet known
Forty patients currently taking zidovudine AZT or any other approved antiretroviral agent will be randomized to one of three treatment arms high-dose nimodipine low-dose nimodipine or placebo Additionally six patients who are intolerant to standard antiretroviral therapy will be randomized to receive high- or low-dose nimodipine Nimodipine is administered by mouth concurrently with patients prestudy dose of antiretroviral agent Treatment is given for 16 weeks and patients are followed every 4 weeks As an option all patients may receive an additional 16 weeks of low-dose nimodipine
Forty patients currently taking zidovudine AZT or any other approved antiretroviral agent will be randomized to one of three treatment arms high-dose nimodipine low-dose nimodipine or placebo Additionally six patients who are intolerant to standard antiretroviral therapy will be randomized to receive high- or low-dose nimodipine Nimodipine is administered by mouth concurrently with patients prestudy dose of antiretroviral agent Treatment is given for 16 weeks and patients are followed every 4 weeks As an option all patients may receive an additional 16 weeks of low-dose nimodipine
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11137 | REGISTRY | DAIDS ES Registry Number | None |