Angiotensin Receptors and Age Related Mitochondrial Decline in HIV Patients (NCT02606279) | Clinical Trial Compass
TerminatedNot Applicable
Angiotensin Receptors and Age Related Mitochondrial Decline in HIV Patients
Stopped: Change in study design and inability to recruit participants
United States1 participantsStarted 2014-07
Plain-language summary
This study is designed to evaluate specific factors in mitochondria that may precipitate premature aging and physical weakness in HIV patients. Angiotensin receptors 1 and 2 (AT1R and AT2R) are found in virtually every cell type. This study will evaluate how the relationships among these receptors in immune and skeletal muscle cells change with HIV, and how these changes might trigger mitochondrial dysfunction, declines in muscle strength, and cellular decline in people living with HIV.
Who can participate
Age range
40 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* able to provide informed consent
* able to attend an extended (\~4 hour) Clinical Research Visit
* documented HIV seropositivity
* on a stable anti-retroviral therapy (ART) regimen for at least 12 months
* HIV plasma viral load \< 50 copies/ml for at least 6 months
* Systolic blood pressure \>110
Exclusion Criteria:
* creatinine \> 1.5 ULN (or creatinine clearance \< 60 ml/min)
* anti-hypertensive therapy with ACE-I or AT1R-blockers
* inability to perform functional measures (e.g. non-ambulatory without assistance, requires a prosthesis)
* recent (within 30 days) acute illness requiring medical therapy or hospitalization
* immunosuppressive agents (e.g. \> 20 mg/d x 2 or more weeks of prednisone or equivalent, chemotherapy) in the last 6 months
* cancer requiring treatment w/in 3 yrs (except for non-melanoma skin cancer)
* blood thinning medications such as Coumadin or Plavix or a bleeding disorder such as hemophilia that could cause complications during muscle biopsies
* pregnancy (will provide urine test for females of child bearing potential)
* regular use of non-steroidal anti-inflammatory drugs or other immune modulating agents.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in 400m Walk
Timeframe: 3, 6, and 9 months post-enrollment
2
Change From Baseline in Grip Strength
Timeframe: 3, 6, and 9 months post-enrollment
3
Change From Baseline in Quantity of AT1R and AT2R on Monocytes