Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036478
Status:
WITHDRAWN
Last Update Posted:
2017-01-19
First Post:
2002-05-10
Brief Title:
Use of Muscle Spectroscopy to Evaluate Mitochondrial Dysfunction in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pilot Study to Evaluate the Use of Phosphorus P31 Nuclear Magnetic Resonance Spectroscopy as a Non-Invasive Means to Evaluate Mitochondrial Dysfunction in HIV-Infected Subjects
Status:
WITHDRAWN
Status Verified Date:
2004-10
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 see if magnetic resonance spectroscopy MRS can be used to detect damage to the mitochondria in HIV-infected patients taking nucleoside reverse transcriptase inhibitor NRTI drugs
HIV-infected patients taking NRTI drugs may have an increase in a chemical in their blood called lactate High lactate levels may damage the energy source of the cell mitochondria Damage to mitochondria may cause lactic acidosis liver failure and other problems It is important to find effective ways to see if the mitochondria of HIV-infected patients have been damaged This study will see if MRS can be used to determine mitochondrial damage
HIV-infected patients taking NRTI drugs may have an increase in a chemical in their blood called lactate High lactate levels may damage the energy source of the cell mitochondria Damage to mitochondria may cause lactic acidosis liver failure and other problems It is important to find effective ways to see if the mitochondria of HIV-infected patients have been damaged This study will see if MRS can be used to determine mitochondrial damage
Detailed Description:
NRTI-related mitochondrial toxicity has been implicated in some fatal cases of lactic acidosis and liver failure In addition some investigators believe NRTI-related mitochondrial toxicity to be the culprit in the development of peripheral neuropathy and lipodystrophy in HIV-infected patients There is a need for a sensitive reproducible and noninvasive marker of mitochondrial dysfunction To date the only available noninvasive marker is lactate but lactate testing is insensitive and the significance and reproducibility of lactate levels in the HIV-infected population are questionable Spectroscopy promises to be a very useful alternative for the evaluation of the in vivo effect of NRTIs on mitochondrial function
Prior to the screening visit HIV-infected participants must fast for at least 12 hours and refrain from exercise for at least 24 hours At the screening visit all participants have blood drawn for lactate measurements and tests for hepatitis B and C HIV-uninfected participants have an HIV test Women who are able to become pregnant have a pregnancy test
Prior to the entry visit HIV-infected participants must fast for 12 hours and refrain from exercise for 3 days At the entry visit all participants have blood drawn for lactate measurements and women have repeat pregnancy tests Participants have an MRS scan which takes approximately 60-80 minutes
Prior to the screening visit HIV-infected participants must fast for at least 12 hours and refrain from exercise for at least 24 hours At the screening visit all participants have blood drawn for lactate measurements and tests for hepatitis B and C HIV-uninfected participants have an HIV test Women who are able to become pregnant have a pregnancy test
Prior to the entry visit HIV-infected participants must fast for 12 hours and refrain from exercise for 3 days At the entry visit all participants have blood drawn for lactate measurements and women have repeat pregnancy tests Participants have an MRS scan which takes approximately 60-80 minutes
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 |
|---|---|---|---|
| AACTG A5144 | None | None | None |