Ignite Creation Date:
2024-05-05 @ 9:22 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00863057
Status:
TERMINATED
Last Update Posted:
2021-11-04
First Post:
2009-03-16
Brief Title:
Combination Pain Therapy in HIV 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 Randomized Double-Blind Placebo-Controlled Study of Duloxetine and Methadone for the Treatment of HIV-Associated Painful Peripheral Neuropathy
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to slow rate of enrollment which compromised the ability to meet study objectives in a timely manner
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neuropathy results from damage to the nerves in the feet and legs It is usually experienced as pain tingling or numbness In HIV-infected people neuropathy can result from the infection itself or be a side effect of antiretroviral treatment The purpose of this study is to determine whether two different drugs methadone and duloxetine reduce neuropathy-associated pain in HIV-infected people This study will also examine whether utilization of both of these drugs is more effective than treatment with only one
Detailed Description:
Peripheral neuropathy is now recognized as the most common neurological complication of HIV disease and its treatment Before highly active antiretroviral therapy HAART was introduced the prevalence of HIV-associated distal sensory polyneuropathy DSP was already estimated to be 35 mostly contained to populations with moderate to advanced immunosuppression Now since the advent of HAART the prevalence of HIV-associated neuropathy has increased to 52 possibly due to a combination of antiretroviral toxic neuropathy ATN decreased mortality and accumulated medical comorbidities
Successful treatment of neuropathic pain is inherently difficult and treatment of HIV-associated neuropathic pain is particularly complicated To date evidence supporting effective therapies for neuropathic HIV-associated pain is lacking despite several types and classes of drugs having been evaluated in clinical trials This study will evaluate the safety and efficacy of duloxetine methadone and the combination of duloxetine and methadone in painful HIV-associated neuropathy Both of these drugs are approved by the Food and Drug Administration FDA but for purposes unrelated to HIV-associated neuropathy and no previous studies have utilized these two treatments for this purpose
For this study 120 participants with painful HIV-associated neuropathy will be recruited The trial will last for approximately 23 weeks Each participant will receive a total of 4 study treatments The following treatment pairings will be given in a sequence determined by randomization
1 duloxetine and methadone placebo
2 methadone and duloxetine placebo
3 duloxetine and methadone
4 duloxetine placebo and methadone placebo
Each treatment period will last 4 weeks and will be followed by a 1-week combined taper and washout
People wishing to enroll in this study will have a screening visit that will last about 3 hours During this visit participants will have an HIV test physical exam neurologic exam blood drawn electrocardiogram EKG and a pregnancy test if applicable Participants will also be asked about their current health and any medications they may be taking They will also be asked about their mood and be given the results of tests performed at the screening visit
If screening qualifies participants for the study they will return for a pre-entry visit lasting 2 hours During this visit participants will have a limited physical exam and be asked about changes in their health or medicines since screening Participants will also be given a pain diary with instructions to record neuropathy pain every day for each of the 7 days before beginning the study and throughout the study
After beginning the study participants will return to the clinic for another 8 visits These visits are at the end of each 4-week treatment period and at the end of each 1-week crossover period At each visit there will be a limited physical exam and participants will answer questions about their health and medications Participants will also be told the results of routine lab tests and pregnancy tests performed during the study
Successful treatment of neuropathic pain is inherently difficult and treatment of HIV-associated neuropathic pain is particularly complicated To date evidence supporting effective therapies for neuropathic HIV-associated pain is lacking despite several types and classes of drugs having been evaluated in clinical trials This study will evaluate the safety and efficacy of duloxetine methadone and the combination of duloxetine and methadone in painful HIV-associated neuropathy Both of these drugs are approved by the Food and Drug Administration FDA but for purposes unrelated to HIV-associated neuropathy and no previous studies have utilized these two treatments for this purpose
For this study 120 participants with painful HIV-associated neuropathy will be recruited The trial will last for approximately 23 weeks Each participant will receive a total of 4 study treatments The following treatment pairings will be given in a sequence determined by randomization
1 duloxetine and methadone placebo
2 methadone and duloxetine placebo
3 duloxetine and methadone
4 duloxetine placebo and methadone placebo
Each treatment period will last 4 weeks and will be followed by a 1-week combined taper and washout
People wishing to enroll in this study will have a screening visit that will last about 3 hours During this visit participants will have an HIV test physical exam neurologic exam blood drawn electrocardiogram EKG and a pregnancy test if applicable Participants will also be asked about their current health and any medications they may be taking They will also be asked about their mood and be given the results of tests performed at the screening visit
If screening qualifies participants for the study they will return for a pre-entry visit lasting 2 hours During this visit participants will have a limited physical exam and be asked about changes in their health or medicines since screening Participants will also be given a pain diary with instructions to record neuropathy pain every day for each of the 7 days before beginning the study and throughout the study
After beginning the study participants will return to the clinic for another 8 visits These visits are at the end of each 4-week treatment period and at the end of each 1-week crossover period At each visit there will be a limited physical exam and participants will answer questions about their health and medications Participants will also be told the results of routine lab tests and pregnancy tests performed during the study
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 A5252 | Registry Identifier | DAIDS ES | None |
| 10636 | REGISTRY | None | None |