Status:
COMPLETED
Relationship Between Fatigue and Mitochondrial Damage in Patients With HIV/AIDS
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Fatigue
Eligibility:
All Genders
18-55 years
Brief Summary
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 ta...
Detailed Description
Both HIV infection and antiretroviral nucleoside analogues (nucleoside reverse transcriptase inhibitors or NRTIs) are known to affect mitochondrial DNA content and mitochondrial function. A number of ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Men and women, ages 18-55 years, will be considered as potential candidates for this study.
- Persons older than 55 years of age are excluded because of age related declines in mitochondrial number that may confound study results.
- Ability to understand and provide informed consent.
- Willing and able to comply with study requirements and procedures including storage of blood, muscle and adipose tissue samples for use in future studies of HIV, AIDS, immune function, muscle or adipose tissue diseases or other related diseases.
- No or currently controlled depression.
- Negative serum pregnancy test for females at screening and within one week prior to muscle and adipose tissue biopsy.
- Specific lab criteria:
- Absolute neutrophil count greater than 1000/mm(3).
- PT/INR less than or equal to 1.5, PTT less than 45 sec.
- Platelets greater than 75,000/mm(3).
- Hemoglobin greater than or equal to 10.0mg/dl.
- Serum creatinine less than or equal to 1.8mg/dl.
- AST and ALT less than 2 times the upper limit of normal.
- Thyroid stimulating hormone and free thyroxine within normal limits.
- Serum testosterone within normal limits or on adequate replacement.
- Willing to avoid aspirin-containing medications or the non-steroidal anti-inflammatory drug piroxicam (Feldene) for 10 days prior to muscle and adipose tissue biopsy and willing to discontinue other nonsteroidal anti-inflammatory drugs 24 hours prior to biopsy.
- For HIV negative volunteers:
- Negative HIV-1 antibody testing
- For HIV positive volunteers:
- Established HIV diagnosis (documentation of HIV-1 infection by licensed ELISA testing and confirmed by Western Blot).
- HIV infection present greater than or equal to 1 year.
- For patients in the antiretroviral treated group, on a stable combination antiretroviral treatment regimen not containing a protease inhibitor for at least 3 months prior to protocol screening.
- For patients in the non-ART group, no antiretroviral treatment for at least one year.
- Under the care of a primary care physician.
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
March 22 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 10 2014
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00106795
Start Date
March 22 2005
End Date
April 10 2014
Last Update
October 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892