An observational study in Human Immunodeficiency Virus (HIV) and Mitochondrial Diseases, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by University of Colorado, Denver · Observational
Among 83 studies in Mitochondrial Diseases with a site in United States — 20 open to participants now, 22 under way, 3 of them phase 3. Mitochondrial Diseases · United States.
Among the 83 studies in Mitochondrial Diseases with a site in United States, this one is the 27th largest by enrollment of the 31 observational ones that give a count, is one of 7 that started in 2018, is one of 31 observational ones, and was the 53rd registered.
189 studies on the registry are indexed under Mitochondrial Diseases; 60 are open to participants now.
Browse Mitochondrial Diseases studies →20 of the 83 studies in Mitochondrial Diseases with a site in United States are open now. Recruiting first, the newest first:
Pharming Technologies B.V. · Sites in United States, Belgium, Czechia and 6 more countries
Ages 18+
Khondrion BV · Sites in United States, Denmark, France and 4 more countries
Ages 18+
Children's Hospital of Philadelphia · Sites in United States
Ages 8–75 · Healthy volunteers
Children's Hospital of Philadelphia · Sites in United States
Ages 18–65 · Healthy volunteers
University of California, San Diego · Sites in United States
Ages 50+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 40 Mitochondrial Diseases studies recruiting now, 20 (50%) set no upper age limit and 13 (33%) stop at 75 or younger; 19 take children under 18; 17 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
83 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 21 · Phase 3 11 · Phase 4 3
First in 2000; this study’s year is marked. 7 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 14 is below the median of 80 across 65 observational studies indexed under Mitochondrial Diseases.
Median enrollment 38 across the 50 interventional studies, 61 across the 31 observational. Of the 54 that completed or were terminated, 23 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
24 of 83 have an industry lead sponsor. The 10 most frequent:
University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
University of Colorado, Denver has 1 study filed under Mitochondrial Diseases — fewer than ten, so there is no comparison to draw.
9 of the studies in Mitochondrial Diseases with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05422534Phase 3Vanderbilt University Medical CenterCoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease | 2027-06-20 |
| NCT01803906Columbia UniversityTissue Sample Study for Mitochondrial Disorders | 2026-12 |
| NCT02000284University of ArkansasMitochondrial Dysfunction in Autism Spectrum Disorder | 2026-12-31 |
| NCT01694940Columbia UniversityNorth American Mitochondrial Disease Consortium Patient Registry and Biorepository (NAMDC) | 2026-12-31 |
| NCT03639701Columbia UniversityTreatment of TK2 Deficiency With Thymidine and Deoxycytidine | 2026-12-31 |
Add all 9 to your calendar (.ics) → With an account.
Among the 83 studies in Mitochondrial Diseases with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
189 studies on the registry are indexed under Mitochondrial Diseases; 60 are open to participants now.
This study's enrollment of 14 is below the median of 80 across 65 observational studies indexed under Mitochondrial Diseases.
Browse Mitochondrial Diseases studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Compared within Mitochondrial Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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)
Participation in another clinical trial where the therapy is unknown or blinded.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Controls without HIV from a historical pre-approved-IRB-protocol database
ADP/ATP measurement (mitochondrial function)
ADP/ATP ratio between HIV-infected and uninfected subjects
Time frame: At Baseline
Protein citrate synthase
Total protein citrate synthase between HIV-infected and seronegative subjects
Time frame: At Baseline
Respiratory control ratio (RCR)
Respiratory control ratio (RCR) between HIV-infected and uninfected subjects
Time frame: 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
Time frame: At Baseline
Muscle function
Relationship between measures of muscle function (strength, physical function) and mitochondrial function
Time frame: 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.
Time frame: At Baseline
Plan to share: No — IPD is kept private per UC Denver restrictions
No publications or documents are linked to this record.
Ran from Dec 2018 to primary completion in Sep 2019, 8 months.
Of 33 observational studies under Mitochondrial Diseases, half reached primary completion within 169 months of starting (the median), counting those still running; a quarter within 26. This study's 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →