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

Primary Purpose

HIV Infections

Status
Withdrawn
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring Pilot Projects, Exercise, Phosphorus Isotopes, Mitochondria, Lactates, Magnetic Resonance Spectroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria 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. Exclusion Criteria 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.

Sites / Locations

  • University of Alabama at Birmingham
  • University of California, San Diego
  • Univ of California, San Diego Antiviral Research Ctr
  • Univ of Nebraska Med Ctr
  • Univ of Nebraska Medical Ctr
  • Beth Israel Med Ctr
  • Duke University Medical Center
  • Vanderbilt Univ Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 10, 2002
Last Updated
January 18, 2017
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00036478
Brief Title
Use of Muscle Spectroscopy to Evaluate Mitochondrial Dysfunction in HIV-Infected Patients
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
Study Type
Observational

2. Study Status

Record Verification Date
October 2004
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Pilot Projects, Exercise, Phosphorus Isotopes, Mitochondria, Lactates, Magnetic Resonance Spectroscopy

7. Study Design

Enrollment
0 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace McComsey
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Univ of California, San Diego Antiviral Research Ctr
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Univ of Nebraska Med Ctr
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
681985130
Country
United States
Facility Name
Univ of Nebraska Medical Ctr
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
681985400
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Vanderbilt Univ Med Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

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

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