Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000842
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase II Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory 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:
To assess the efficacy safety and tolerability of recombinant human nerve growth factor rhNGF in the treatment of HIV-associated sensory neuropathy AS PER AMENDMENT 5697 To compare the change in viral load between the double-blind phase baseline and week 4 in placebo and active rhNGF recipients To ensure that rhNGF does not induce an increase in viral load compared with viral load changes seen with placebo
Up to now treatments for HIV-associated sensory neuropathy have been symptomatic relying on pain-modifying agents or membrane-stabilizing drugs Because nerve growth factor is important in the development and maintenance of sympathetic and sensory neurons and their outgrowths it is proposed that recombinant human nerve growth factor may provide a specific restorative treatment for HIV-associated painful sensory neuropathy
Up to now treatments for HIV-associated sensory neuropathy have been symptomatic relying on pain-modifying agents or membrane-stabilizing drugs Because nerve growth factor is important in the development and maintenance of sympathetic and sensory neurons and their outgrowths it is proposed that recombinant human nerve growth factor may provide a specific restorative treatment for HIV-associated painful sensory neuropathy
Detailed Description:
Up to now treatments for HIV-associated sensory neuropathy have been symptomatic relying on pain-modifying agents or membrane-stabilizing drugs Because nerve growth factor is important in the development and maintenance of sympathetic and sensory neurons and their outgrowths it is proposed that recombinant human nerve growth factor may provide a specific restorative treatment for HIV-associated painful sensory neuropathy
Patients are randomized to receive either rhNGF at one of two doses or placebo administered subcutaneously twice weekly for 18 weeks Patients are stratified into three groups within their regimens by use of didanosine zalcitabine or stavudine as follows current use vs discontinued between 8 and 26 weeks before randomization vs never used or discontinued use at least 26 weeks before randomization Patients will assess their pain daily using the Gracely Pain Scale AS PER AMENDMENT 5697 After completion of the double-blind phase 18 weeks on treatment followed by 4 weeks off treatment patients may receive open-label active drug treatment according to their previously assigned regimen for an additional 48 weeks
Patients are randomized to receive either rhNGF at one of two doses or placebo administered subcutaneously twice weekly for 18 weeks Patients are stratified into three groups within their regimens by use of didanosine zalcitabine or stavudine as follows current use vs discontinued between 8 and 26 weeks before randomization vs never used or discontinued use at least 26 weeks before randomization Patients will assess their pain daily using the Gracely Pain Scale AS PER AMENDMENT 5697 After completion of the double-blind phase 18 weeks on treatment followed by 4 weeks off treatment patients may receive open-label active drug treatment according to their previously assigned regimen for an additional 48 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 |
|---|---|---|---|
| 11267 | REGISTRY | DAIDS ES Registry Number | None |