Relationship Between Fatigue and Mitochondrial Damage in Patients With HIV/AIDS

Completed

Conditions studied: HIV Infections, Fatigue, HIV Positive, AIDS, Healthy Volunteer, HV

In brief

This study will examine abnormalities in mitochondria (energy-producing machinery of cells) and in genes related to mitochondria in the blood cells, muscle, and fat of HIV-positive patients who are taking nucleoside reverse transcriptase inhibitors (NRTIs) and in patients not currently taking HIV medications, and compare the results to healthy volunteers. Many patients with HIV infection take NRTIs to help control the infection. These medications may damage cell mitochondria, possibly causing side effects such as fatigue. This study will explore the relationship between changes in mitochondria and related genes and patient reports of energy level, mood and quality of life. Healthy volunteers and HIV-infected patients between 18 and 55 years of age may be eligible for this study. Healthy volunteers must test negative for the HIV antibody. HIV-positive patients must have been diagnosed positive for at least 1 year. Patients who are taking antiretroviral therapy must have been taking the same drug regimen (with at least two NTRIs and no protease inhibitors) for at least 3 months. HIV positive patients not taking antiretroviral medication must not have had antiretroviral therapy for at least 1 year. Candidates are screened with a medical history, brief physical examination, blood and urine tests, and questionnaires related to mood and energy. Qualified volunteers will undergo the following procedures during three or four study visits: Visit 1 Complete history and physical examination, blood tests, and questionnaires about energy level, mood, and quality of life. Visit 2 Muscle and fat biopsy: Before the biopsy, blood is drawn to check blood counts and to test for pregnancy in women who can become pregnant. The biopsy is done on an outpatient basis in the operating room. The site of the biopsy (an area on the upper arm or upper leg) is numbed with an injection under the skin. A 1-inch incision is made over the muscle to be biopsied and a small sample of muscle tissue and small sample of fat are removed. The incision is then closed and bandaged. Following the biopsy, you will be monitored for about 4 hours in the clinic. Strenuous physical activity should be restricted in the week following biopsy to allow healing. Visit 3 Examination of biopsy site and possible apheresis: The biopsy site is examined for healing. Apheresis may be scheduled for this visit or for an extra visit between the biopsy and the final visit. This procedure for obtaining white blood cells for study is optional. For apheresis, blood is withdrawn from a needle placed in a vein in the arm and the white cells are separated from the rest of the blood. The white cells are extracted and the red cells and plasma are then returned to the body through a second needle.

Key facts

Study ID

NCT00106795

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

82

Starts

2005-03-22

Expected to finish

2014-04-10

Last updated by the study team

2017-10-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Unable to provide informed consent.
• Unable to understand protocol required questionnaires including inability to comprehend English (the fatigue questionnaires have not been validated in languages other than English).
• Pregnant or breast-feeding.
• Current treatment with an ARV regimen containing a protease inhibitor.
• Opportunistic infection requiring treatment.
• Concurrent malignancy requiring cytotoxic chemotherapy or radiation therapy.
• History of myopathy or myositis.
• Untreated or uncontrolled depression by clinical history or as indicated by a score on the Beck's Depression Inventory of greater than or equal to 19.
• Severe psychiatric disorder that would interfere with adherence to protocol requirements.
• Severe sleep disturbance.
• Current alcohol or substance abuse.
• Diabetes mellitus requiring drug therapy.
• Decompensated cardiac or pulmonary disease.
• Current use or a history of treatment with interleukin-2, interferon-alpha or other investigational agent(s) within 6 months of protocol screening.
• Corticosteroid, immunosuppressive or cytotoxic agent use within 90 days of trial screening.
• Any medical condition for which the principal investigator feels muscle and adipose tissue biopsy may be contraindicated.
• Allergy to lidocaine.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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