PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using [11C]PBR28 in HIV-Seropositive Patients With (MCMD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT00459693
First received: April 11, 2007
Last updated: April 8, 2014
Last verified: February 2014

April 11, 2007
April 8, 2014
April 2007
April 2014   (final data collection date for primary outcome measure)
Brain uptake of [11C]PBR28 (measured as distribution volume). [ Time Frame: One brain PET scan in one outpatient visit to NIH per subject. ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00459693 on ClinicalTrials.gov Archive Site
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PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using [11C]PBR28 in HIV-Seropositive Patients With (MCMD)
PET Evaluation of Brain Peripheral Benzodiazepine Receptors Using (11C)PBR28 in HIV-Seropositive Patients With (MCMD)

The purpose of this protocol is to measure a receptor in the brain using positron emission tomography (PET) that is involved in inflammation.

The peripheral benzodiazepine receptor (PBR) is distinct from central benzodiazepine receptors associated with GABAa receptors. Although PBR was initially identified in peripheral organs such as kidneys, endocrine glands and lungs, later studies identified PBR in the central nervous system. In normal conditions, PBR is expressed in low levels in some neurons and glial cells. PBR can be a clinically useful marker to detect neuroinflammation, because activated microglial cells in inflammatory areas express much greater levels of PBR than in microglial cells in resting conditions.

PBR has been imaged with positron emission tomography (PET) using [11C]1-(2-chlorophenyl-N-methylpropyl)-3-isoquinoline carboxamide (PK11195). However, this classical ligand provides low levels of specific signal. Recently we developed a new ligand, N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine [11C]PBR28, which showed much greater specific signal than [11C]PK11195 in non-human primates. ln the present protocol we plan to perform a kinetic brain imaging study with [11C]PBR28 in HlV-seronegative controls, HIV-seropositive, non-impaired patients, and HlV-seropositive patients with minor cognitive motor disorder(MCMD). Each subject will recieve a brain-dedicated PET scan with 20 mCi[(11)C]PBR28.

Interventional
Not Provided
Primary Purpose: Treatment
  • HIV-Dementia
  • HIV-Associated Cognitive Motor Complex
  • AIDS Encephalopathy
  • AIDS Dementia Complex
  • AIDS-Related Dementia Complex
  • HIV Infections
  • Healthy
Drug: [11C]PBR28
N/A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2014
April 2014   (final data collection date for primary outcome measure)
  • INCLUSION CRITERIA:

Inclusion criteria (healthy control subjects) aged 18 50 years with history/physical exam, ECG, and laboratory tests, plus inclusion criteria listed will be included in the protocol.

  1. HIV-seropositive based on ELISA and Western blot (except the HIV-seronegative subjects, who will have ELISA screening).
  2. Capable of providing informed consent.
  3. Ambulatory at initial visit.
  4. If cognitively impaired, the degree of impairment will be MCMD, and not frank HIV-associated dementia.

EXCLUSION CRITERIA:

  1. Current psychiatric illness or severe systemic disease based on history and physical exam
  2. Current dependence on alcohol or substances other than nicotine.
  3. Laboratory results from blood or urine tests that show clinically significant abnormalities.
  4. Previous radiation exposure (X-rays, PET scans etc.) that would exceed research limits.
  5. Pregnancy and breast feeding.
  6. A history of brain disease.
  7. Cannot lie on your back for long periods since the pictures will be taken for about 2.5 hours during which time you will have to lie still on the scanner bed.
  8. More than moderate hypertension.
  9. Positive result on urine screen for illicit drugs.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00459693
070129, 07-M-0129
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: William C Kreisl, M.D. National Institute of Mental Health (NIMH)
National Institutes of Health Clinical Center (CC)
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP