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Peripheral Reservoir of HIV DNA in Monocytes Pivotal to Cognition in HIV

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ClinicalTrials.gov Identifier: NCT00782808
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : September 26, 2014
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii

Tracking Information
First Submitted Date October 29, 2008
First Posted Date October 31, 2008
Last Update Posted Date September 26, 2014
Study Start Date March 2009
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 25, 2014)
To determine the long-term relationship between cognition and HIV DNA in circulating PBMCs and monocytes (CD14+ PBMCs) among patients initiating HAART for the first time [ Time Frame: After March 30, 2016 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Peripheral Reservoir of HIV DNA in Monocytes Pivotal to Cognition in HIV
Official Title Not Provided
Brief Summary Sixty HIV participants will be enrolled and stratified by PBMC HIV DNA levels, either high (greater than or equal to 5000 copies/106 cells) or low (less than 5000 copies/106 cells). Individuals will be enrolled into each group until filled. Screening PBMC HIV DNA levels will be performed at SEARCH in real-time with less than one-week turn around time. All individuals will intend to initiate ARV due to meeting MOPH guidelines for such. The protocol team will work with the primary care physician to facilitate initiation of standard ARV care; however, initiation of ARV is not a requirement of the study and ARV will not be provided by the study.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population HIV-infected individuals meeting MOPH criteria to initiate HAART and planning to initiate HAART within a month of screening. Consequently, all participants will have plasma CD4 counts at less than 250 cells.
Condition HIV Infections
Intervention Not Provided
Study Groups/Cohorts
  • 1 HIV DNA will be stratified by high
  • 2 HIV DNA will be stratified by low
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 29, 2008)
60
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • HIV-infected individuals meeting MOPH criteria to initiate HAART and planning to initiate HAART within a month of screening.
  • Consequently, all participants will have plasma CD4 counts at less than 250 cells.

Exclusion Criteria:

  • Head injury with loss of consciousness greater than 1 hour or cognitive sequela
  • Current/past illicit drug use or positive drug screen for methamphetamines, amphetamines, or cocaine at screening or entry.
  • Any of the following laboratory abnormalities:

    • PT/PTT > the upper limit of normal (ULN) or INR > 1.1
    • Hemoglobin < 9.0 mg/dL
    • ALT > 5x ULN
    • serum creatinine > 2x ULN or creatinine clearance < 30 cc per min by Cockroft-Gault formula
  • Acute illness within 30 days prior, persistent and active AIDS-defining OI of any organ system or autoimmune disease.
  • Current or recent fevers or meningeal signs suggestive of CNS opportunistic infection
  • CNS opportunistic infection, past or present (Patients diagnosed with opportunistic infection after CSF examination will be excluded from further analysis. In such a situation, an additional patient will be enrolled)
  • History of pre-existing neurologic disease to include stroke, multiple sclerosis or psychiatric illness including schizophrenia, bipolar disorder, anxiety disorder, panic attacks, major depression, or post traumatic stress disorder. Patients with past depression that is controlled and patients with or minor depressive symptoms will be allowed to enroll.
  • Known learning disability including dyslexia or unable to read or write basic Thai
  • Positive Hepatitis C serology (Hepatitis C Ab)
  • Confusion or other signs and symptoms of metabolic encephalopathy or delirium
  • Other conditions that could explain neurocognitive decline in the opinion of the investigator such as hypothyroidism, vitamin B12 deficiency or neurosyphilis
  • Pregnancy or metal objects that would preclude MRI
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Thailand
Removed Location Countries  
 
Administrative Information
NCT Number NCT00782808
Other Study ID Numbers SEARCH 011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii
Study Sponsor South East Asia Research Collaboration with Hawaii
Collaborators National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Victor Valcour, MD University of Hawii
PRS Account South East Asia Research Collaboration with Hawaii
Verification Date September 2014