Use of Muscle Spectroscopy to Evaluate Mitochondrial Dysfunction in HIV-Infected Patients
|ClinicalTrials.gov Identifier: NCT00036478|
Recruitment Status : Withdrawn
First Posted : May 13, 2002
Last Update Posted : January 19, 2017
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|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|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036478
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92093|
|Univ of California, San Diego Antiviral Research Ctr|
|San Diego, California, United States, 92103|
|United States, Nebraska|
|Univ of Nebraska Med Ctr|
|Omaha, Nebraska, United States, 681985130|
|Univ of Nebraska Medical Ctr|
|Omaha, Nebraska, United States, 681985400|
|United States, New York|
|Beth Israel Med Ctr|
|New York, New York, United States, 10003|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Tennessee|
|Vanderbilt Univ Med Ctr|
|Nashville, Tennessee, United States, 37203|
|Study Chair:||Grace McComsey|