NIAID HIV and Emerging Infectious Diseases Program

MITOX Study

Study name

Assessing the Relationship Between Fatigue and Mitochondrial Toxicity in Patients with HIV/AIDS

Study number

05-CC-0127

Goal of Study

The NIH is conducting a research study to evaluate energy levels and the association of energy with abnormalities in mitochondria, the energy producing machinery of cells. HIV-positive people on no HIV medications are being recruited. The study will involve a screening visit, physical exam, laboratory tests, completion of questionnaires, and a fat and muscle biopsy procedure.

Study Regimen

We will obtain a muscle biopsy (a sample of tissue) for examination. This biopsy will either be from the upper arm or upper leg, and will be performed as an outpatient procedure. An incision of about 1-inch will be necessary for the biopsy, and the incision will require absorbable stitches that will dissolve and not need to be removed. This procedure may leave a 1-2 inch scar. Volunteers will be compensated.

Eligibility Criteria

• You are age 18-55, with documented HIV-infection
• You are willing to have a muscle biopsy
• You have adequate access for blood drawing
• You have a primary care physician
• You are not on antiretroviral therapy for HIV for at least 12 months
• You are willing to stop taking aspirin-containing drugs one week before the biopsy procedure, to decrease the risk of bleeding
• You are not pregnant
• You are not currently suffering from uncontrolled depression or a severe psychiatric disturbance
• You do not have diabetes requiring treatment
• You are not allergic to lidocaine

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