Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050271
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2002-12-03
Brief Title:
Acetyl-L-Carnitine for the Treatment of NRTI-Associated Peripheral Neuropathy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open-Label Dose-Escalation Pilot Study of Acetyl-L-Carnitine for the Treatment of Dideoxynucleoside-Associated Distal Symmetric Peripheral Neuropathy
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:
The purpose of this study is to determine if acetyl-L-carnitine ALC reduces pain numbness and tingling in the feet and legs of patients with nucleoside reverse transcriptase inhibitor NRTI-associated peripheral neuropathy Another purpose is to determine if ALC is safe and tolerable in HIV patients who have taken certain anti-HIV drugs
Detailed Description:
Distal symmetric peripheral neuropathy DSPN is the most frequent neurologic complication of HIV infection and its treatments NRTIs particularly dideoxy-NRTIs represent a significant risk factor for developing neuropathy To date there are no effective treatments for DSPN Studies of nonneuronal tissues indicate a beneficial effect of ALC in HIV-1 seropositive individuals but the role of ALC levels in patients with DSPN is unclear Despite conflicting data carnitine and its derivatives are still commonly used
Patients will have a screening visit and visits at entry and Weeks 6 12 18 and 24 Patients are required to fast no food or drink except water for 4-12 hours for the screening visit entry visit and at Weeks 12 and 24 Targeted physical examinations blood chemistries liver function tests HIV-1 RNA CD4CD8 cell counts hematology and lactate assessments will be done Patients will also have a small skin biopsy at entry and Week 24 Patients will begin with 1 tablet of ALC twice daily and escalate dosage to a target dose of 3 tablets daily They will remain on the 3-tablet dose or a maximum tolerated dose for the duration of the study 24 weeks
Patients will have a screening visit and visits at entry and Weeks 6 12 18 and 24 Patients are required to fast no food or drink except water for 4-12 hours for the screening visit entry visit and at Weeks 12 and 24 Targeted physical examinations blood chemistries liver function tests HIV-1 RNA CD4CD8 cell counts hematology and lactate assessments will be done Patients will also have a small skin biopsy at entry and Week 24 Patients will begin with 1 tablet of ALC twice daily and escalate dosage to a target dose of 3 tablets daily They will remain on the 3-tablet dose or a maximum tolerated dose for the duration of the study 24 weeks
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 |
|---|---|---|---|
| ACTG A5157 | Registry Identifier | DAIDS ES | None |
| 10004 | REGISTRY | None | None |