NCT00036478

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

8 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2002

Completed
Last Updated

January 19, 2017

Status Verified

October 1, 2004

First QC Date

May 10, 2002

Last Update Submit

January 18, 2017

Conditions

HIV Infections

Keywords

Pilot ProjectsExercisePhosphorus IsotopesMitochondriaLactatesMagnetic Resonance Spectroscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California, San Diego

La Jolla, California, 92093, United States

Location

Univ of California, San Diego Antiviral Research Ctr

San Diego, California, 92103, United States

Location

Univ of Nebraska Med Ctr

Omaha, Nebraska, 681985130, United States

Location

Univ of Nebraska Medical Ctr

Omaha, Nebraska, 681985400, United States

Location

Beth Israel Med Ctr

New York, New York, 10003, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Vanderbilt Univ Med Ctr

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

HIV InfectionsMotor Activity

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavior

Study Officials

  • Grace McComsey

    STUDY CHAIR
0

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 10, 2002

First Posted

May 13, 2002

Last Updated

January 19, 2017

Record last verified: 2004-10

Locations

US(8)