The general hypothesis of the proposed pilot study is that older, HIV-infected individuals with a prolonged antiretroviral therapy (ART) treatment history experience an even greater burden of mitochondrial dysfunction, and resulting 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).
o Between the ages of 50-75 years at study entry o Known HIV infection or presumed HIV uninfected (will be confirmed at screening) o 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. We 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), we 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 o All participants must be able to perform activities of daily living without assistance, and ambulate independently. o Sedentary as defined above o 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. o Body mass index between 25-38 kg/m2
Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.
University of Colorado Hospital
Protocol Number: 17-2161
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