Mild Neurocognitive Disorder in HIV Infection of the Brain (NCT01547754) | Clinical Trial Compass
TerminatedNot Applicable
Mild Neurocognitive Disorder in HIV Infection of the Brain
United States8 participantsStarted 2012-01-09
Plain-language summary
Background:
\- Some people with human immunodeficiency virus (HIV) develop problems with thinking and concentration when the virus affects the brain. This is known as mild neurocognitive disorder (MND). Research has shown that some HIV medications do not get through the blood brain barrier very well. P-glycoprotein (P-gp) is a brain protein that is part of the blood brain barrier. Differences in the activity of P-gp may help explain why some people with HIV develop MND. It is also possible that MND is partly due to inflammation in the brain. Researchers want to study P-gp and its effect on MND and HIV infection.
Objectives:
\- To study P-gp and brain inflammation related to HIV infection.
Eligibility:
* Individuals between 18 and 60 years of age who have HIV and either do or do not have MND.
* Healthy volunteers between 18 and 60 years of age.
Design:
* Participants will be screened with a medical history and physical exam. Blood and urine samples will be collected.
* Participants will have one outpatient visit and one 3-day inpatient stay.
* At the outpatient visit, participants will provide blood samples and have a lumbar puncture (spinal tap). The spinal tap will collect cerebrospinal fluid for study.
* At the inpatient visit, participants will have two positron emission tomography (PET) scans of the brain. These scans will study brain activity and possible inflammation. One scan will involve a study drug called tariquidar, which blocks the activity of P-gp. A second lumbar puncture will be done before the first PET scan. Blood and urine samples will be collected daily.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Subjects must be between 18 and 60 years of age.
✓. Capable of providing informed consent.
✓. Ambulatory at initial visit.
✓. Speak English fluently
✓. For HIV seropositive subjects:
✓. Confirmation of HIV antibody status by ELISA and Western Blot
✓. Documented HIV-infection for at least one year
✓. On a stable antiretroviral regimen that includes a protease inhibitor for at least 3 months and have a viral load \< 400 copies/mL.
Exclusion criteria
✕. Current Axis I psychiatric illness or severe systemic disease (other than HIV and MND) based on history and physical exam that would make study participation unsafe in the opinion of the investigators.
✕. Current alcohol use greater than 14 drinks per week for men and 7 drinks per week for women.
What they're measuring
1
Brain uptake of [11C]dLop after pharmacological challenge with the P-gp inhibitor tariquidar.
✕. Laboratory tests with clinically significant abnormalities. Normal organ and marrow function are defined as: total leukocyte count greater than or equal to 3000 cells/ul, ANC greater than or equal to 1500 cells/ul, platelet count greater than or equal to 100,000 cells/ul, serum creatinine less than or equal to 2.0 times upper limit of normal, hemoglobin greater than or equal to 9.0 g/dL, serum calcium \<12.0 mg/dL, AST/ALT less than or equal to 1.5 times the upper limit of normal, PT 1.5 upper limit of normal.
✕. EKG finding consistent with ischemic heart disease unless there is documentation of normal cardiac function (e.g., normal stress test or echocardiogram results).
✕. Previous research radiation exposure (X-rays, PET scans etc.) that, with the study PET scans, would exceed annual research limits.
✕. Pregnancy or breast feeding.
✕. Evidence of brain disease such as stroke, tumor, epilepsy, traumatic brain injury, or any neurodegenerative disease on history or on screening MRI.
✕. Inability to lay on his/her back for long periods, severe claustrophobia, pacemaker, or other contraindication for MRI.