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NCT00106795 · ClinicalTrials.gov registry record
Relationship Between Fatigue and Mitochondrial Damage in Patients With HIV/AIDS
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 82
- Enrollment target
NCT00106795: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00106795 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 82 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00106795 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 82 participants
- Enrollment target
Study 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 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 tiss
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2005-03-22 |
| Est. Completion | 2014-04-10 |
What the finished NCT00106795 record still lists
NCT00106795 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 82 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00106795 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00106795 about?
NCT00106795 is a clinical study titled "Relationship Between Fatigue and Mitochondrial Damage in Patients With HIV/AIDS". 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 me...
What is the current status of trial NCT00106795?
This trial is currently completed. The enrollment target is 82 participants. The study started on 2005-03-22. Estimated completion is 2014-04-10.
Who is sponsoring clinical trial NCT00106795?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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