Use of Muscle Spectroscopy to Evaluate Mitochondrial Dysfunction in HIV-Infected Patients

Withdrawn before enrolling

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00036478

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

0

Last updated by the study team

2017-01-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants in Groups 1 and 2 may be eligible for this study if they:
• Are at least 18 years old.
• Participants in Group 1 (HIV-uninfected) may be eligible for this study if they:
• Are HIV-uninfected within 30 days prior to study entry.
• Participants in Group 2 (HIV-infected) may be eligible for this study if they:
• Are HIV infected.
• Have been taking an NRTI-containing anti-HIV drug regimen for 8 weeks or more prior to study entry.
• Have a nonexercise venous lactate level greater than 2 times the upper limit of normal (ULN) on 2 repeated measurements.

You may not qualify if…

• Participants in Groups 1 and 2 may not be eligible for this study if they:
• Have severe claustrophobia.
• Have severe symptoms that, in the opinion of the investigator, would interfere with the ability of participants to perform the exercise required for spectroscopy testing.
• Have hepatitis C or B, within 90 days prior to study entry.
• Have taken certain drugs within 30 days prior to study entry.
• Have a medical condition associated with chronic liver disease other than hepatitis C and B.
• Have consumed excessive amounts of alcohol in the past 12 months.
• Are pregnant or breast-feeding.
• Have a foreign object or metal in their body that would impair MRS testing.
• Have or have had peripheral vascular disease.
• Weigh 250 lbs or more.
• Have a family history of mitochondrial disease or have skeletal muscle disease, heart muscle disease, or nervous system conditions without a clearly defined cause that is not related to mitochondria.
• Participants in Group 1 (HIV-uninfected) may not be eligible for this study if they:
• Have any active medical condition.
• Use any prescription drugs, except for vitamins or oral contraceptives.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California, San Diego — La Jolla, California, United States
• Univ of California, San Diego Antiviral Research Ctr — San Diego, California, United States
• Univ of Nebraska Med Ctr — Omaha, Nebraska, United States
• Univ of Nebraska Medical Ctr — Omaha, Nebraska, United States
• Beth Israel Med Ctr — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Vanderbilt Univ Med Ctr — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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