Human Immunodeficiency Virus (HIV)(MITO+)NCT03489421
Mitochondria in HIV and Aging (MITO+)
An observational study of Human Immunodeficiency Virus (HIV) and Mitochondrial Diseases, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Older adults with human immunodeficiency virus (HIV) and a long history of antiretroviral therapy have more mitochondrial dysfunction- the cells that help them make energy. This dysfunction in mitochondria may lead to symptoms of muscle fatigue, physical function impairment, and impaired exercise tolerance compared to… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Human Immunodeficiency Virus (HIV), Mitochondrial Diseases
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2018to 5 Sep 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected participants will be those living with HIV, between the ages of 50-75 years, recruited from the University of Colorado Infectious Diseases Group Practice HIV-uninfected participants were previous enrolled and completed an IRB approved protocol (historical database).
Who may be able to join
- Between the ages of 50-75 years at study entry (a subset of participants changing from TDF-based ART to TAF-based ART will also have mitochondrial function measured and the age range for this subset is 18-70)
- Known HIV infection or presumed HIV uninfected (will be confirmed at screening)
- For HIV+ participants: must be on an ART regimen (change in regimen permitted for preference/tolerability but not for virologic failure) for a minimum of 5 years, with a viral load < 200 during the prior 2 years. The investigators will initially target 10 years of therapy, but will expand to 5 years if needed for enrollment.
- Although any ART regimen will be allowed if effective (as above), the investigators will first target participants that have a history of > 5 years of TDF exposure and are currently on TAF or TDF, but no prior exposure to AZT or stavudine.
- CD4 T-cell count greater than 200 cells/mm3
- All participants must be able to perform activities of daily living without assistance, and ambulate independently.
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- Sedentary as defined above
- Post-menopausal as defined by cessation of menstrual periods for at least 12 months without any other obvious pathological or physiological cause OR removal of ovaries at least 12 months prior to enrollment.
- Body mass index between 25-38 kg/m2
Who cannot join
- Participation in another clinical trial where the therapy is unknown or blinded.
- Diabetes, as defined by use of diabetes medications, hemoglobin A1c 6.5 or greater, fasting plasma glucose 126 mg/dL or greater, or random plasma glucose 200 mg/dL or greater.
- Persons on statin therapy (as possible; this criteria may be removed for recruitment difficulties).
- Fasting triglycerides > 400
- Untreated or incompletely treated thyroid disease will be excluded; stable therapy for > 6 months will be allowed.
- Persons on growth hormone or growth hormone axis therapy (i.e., tesamorelin) will be excluded.
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- The investigators will initially target men, women, or transgendered individuals without replacement hormone use. If the investigators are unable to recruit the target number of participants, stable (>3 months) estrogen or testosterone within physiologic replacement dose range will be permitted.
- Corticosteroid use, including intra-articular, will be excluded (within 3 months for oral; within 6 months for intra-articular); inhaled or intranasal will be permitted.
- Immunosuppressive medications within 6 months, including methotrexate, infliximab, azathioprine, etc.
- Women that are pregnant, breast-feeding, or intend to become pregnant.
- Known hepatitis B or C with detectable viremia within in the past 6 months.
- Hepatitis C with undetectable viral load for at least 6 months will be allowed.
- Known mitochondrial disorder
- Severe liver disease other than hepatitis B or C due to interference with systemic cytokine production
- Uncontrolled hypertension defined as resting systolic blood pressure (BP) >180 mmHg or diastolic BP >100 mmHg
- Indicators of unstable ischemic heart disease
- New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia
- Pulmonary disease requiring the use of supplemental oxygen
- Active malignancy (excluding non-melanoma skin cancers) within 24 weeks prior to enrollment
- Surgery/trauma/injury/fracture within 12 weeks prior to enrollment that may limit ability to perform physical function testing.
- Acute infection (skin infection, sinus infection, uncomplicated upper respiratory infection, dental infection, etc) within 2 weeks of study entry will be excluded until the infection has resolved for at least 2 weeks
- Chronic, deeper infections (complicated pneumonia, bone infection, liver abscess, deep wound infection, etc) must have completed treatment and show no evidence of ongoing infection for at least 12 weeks
- History of stroke with residual deficits
- Any medical condition that does not allow for a non-contrasted MRI study (ie, pacemaker, shrapnel, other devices or hardware)
- AIDS-defining opportunistic infection75 within the 24 weeks prior to enrollment
- Severe anemia, defined as a hemoglobin of 9 mg/dL or less
- Participants on anticoagulants (clopidogrel, Coumadin, etc). Patients on short-acting anticoagulant therapy requiring dose cessation for only 48-72 hours can be considered for muscle biopsy with approval by their treating physician.
- Aspirin and Non-steroidal anti-inflammatory agents are not exclusions but should be stopped 1 week prior to biopsy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Older adults with human immunodeficiency virus (HIV) and a long history of antiretroviral therapy have more mitochondrial dysfunction- the cells that help them make energy. This dysfunction in mitochondria may lead to symptoms of muscle fatigue, physical function impairment, and impaired exercise tolerance compared to HIV-uninfected controls of a similar age and body mass index (BMI). Furthermore, the investigators hypothesize that the older antiretroviral therapy (ART) of tenofovir disoproxil fumarate (TDF) is associated with greater impairment in mitochondrial function than the newer agent, tenofovir alafenamide (TAF).
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV Infected | Not described | |
| Un-infected controls | Controls without HIV from a historical pre-approved-IRB-protocol database |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADP/ATP measurement (mitochondrial function)
ADP/ATP ratio between HIV-infected and uninfected subjects
Measured: At Baseline
Secondary outcomes (5)
Protein citrate synthase
Total protein citrate synthase between HIV-infected and seronegative subjects
Measured: At Baseline
Respiratory control ratio (RCR)
Respiratory control ratio (RCR) between HIV-infected and uninfected subjects
Measured: At Baseline
Inflammatory markers
Relationship between markers of inflammation (final panel to be determined, but most likely sTNFR1 and 2 in addition to multiplex panel of IL-6, IL-10, CRP, IFN-G) and their effect on mitochondrial function
Measured: At Baseline
Muscle function
Relationship between measures of muscle function (strength, physical function) and mitochondrial function
Measured: At Baseline
TDF to TAF change
A separate group of participants changing from TDF-based ART to TAF-based ART will also have mitochondrial function measures before and after change. The inclusion criteria are similar except the age range is 18-70.
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start15 Dec 2018
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489421
- Sponsor's protocol ID
- 17-2161
- Acronym
- (MITO+)
- Status last verified
- Sep 2019
- First submitted
- 25 Mar 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is kept private per UC Denver restrictions
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondria in HIV and Aging (MITO+)
- ClinicalTrials.gov ID
- NCT03489421
- Acronym / sponsor ID
- (MITO+) / 17-2161
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 5 Apr 2018 (actual)
- 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.
Older adults with human immunodeficiency virus (HIV) and a long history of antiretroviral therapy have more mitochondrial dysfunction- the cells that help them make energy. This dysfunction in mitochondria may lead to symptoms of muscle fatigue, physical function impairment, and impaired exercise tolerance compared to HIV-uninfected controls of a similar age and body mass index (BMI). Furthermore, the investigators hypothesize that the older antiretroviral therapy (ART) of tenofovir disoproxil fumarate (TDF) is associated with greater impairment in mitochondrial function than the newer agent, tenofovir alafenamide (TAF).
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV Infected | – | – |
| Un-infected controls | – | –Controls without HIV from a historical pre-approved-IRB-protocol database |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected participants will be those living with HIV, between the ages of 50-75 years, recruited from the University of Colorado Infectious Diseases Group Practice HIV-uninfected participants were previous enrolled and completed an IRB approved protocol (historical database).
Key inclusion criteria (9 listed)
Key exclusion criteria (28 listed)
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
ADP/ATP measurement (mitochondrial function)
Time frame: At Baseline
ADP/ATP ratio between HIV-infected and uninfected subjects
5 secondary outcomes
Protein citrate synthase
Time frame: At Baseline
Respiratory control ratio (RCR)
Time frame: At Baseline
Inflammatory markers
Time frame: At Baseline
Muscle function
Time frame: At Baseline
TDF to TAF change
Time frame: At Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: No. IPD is kept private per UC Denver restrictions
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus (HIV) and Mitochondrial Diseases, run by University of Colorado, Denver at 1 site 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 9 inclusion and 28 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: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
ADP/ATP measurement (mitochondrial function) (time frame: At Baseline). It is what the study was designed to measure, not a finding.
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 26 Sep 2019; AzTrials last refreshed its copy on 30 Oct 2026.