HIV InfectionsNCT00036478
Use of Muscle Spectroscopy to Evaluate Mitochondrial Dysfunction in HIV-Infected Patients
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 0 participants
- Where
- 8 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Duke University Medical Center
Durham, North Carolina, 27710
University of California, San Diego
La Jolla, California, 92093
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
Beth Israel Med Ctr
New York, New York, 10003
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
Univ of Nebraska Medical Ctr
Omaha, Nebraska, 681985400
Univ of California, San Diego Antiviral Research Ctr
San Diego, California, 92103
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections
- Keywords
- Pilot Projects, Exercise, Phosphorus Isotopes, Mitochondria, Lactates, Magnetic Resonance Spectroscopy
- Medical subject headings
- HIV Infections, Motor Activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Grace McComsey, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036478
- Sponsor's protocol ID
- ACTG A5144
- Other IDs
- AACTG A5144
- Status last verified
- Oct 2004
- First submitted
- 10 May 2002
- Last updated
- 19 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00036478
- Acronym / sponsor ID
- ACTG A5144
- Conditions
- HIV Infections
- Keywords
- Pilot Projects, Exercise, Phosphorus Isotopes, Mitochondria, Lactates, Magnetic Resonance Spectroscopy
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 13 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Are at least 18 years old.
- Are HIV-uninfected within 30 days prior to study entry.
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace McComsey study chair
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.