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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier:
NCT00782808
First received: October 29, 2008
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by South East Asia Research Collaboration with Hawaii:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2009
Study Completion Date: April 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1 HIV DNA will be stratified by high
2 HIV DNA will be stratified by low

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782808

Locations
Thailand
SEARCH Thailand
Bangkok, Thailand
Sponsors and Collaborators
South East Asia Research Collaboration with Hawaii
Investigators
Principal Investigator: Victor Valcour, MD University of Hawii
  More Information

Additional Information:
No publications provided

Responsible Party: Assoc.Prof.Jintanat Ananworanich, M.D., Assoc.Prof, South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier: NCT00782808     History of Changes
Other Study ID Numbers: SEARCH 011
Study First Received: October 29, 2008
Last Updated: September 25, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by South East Asia Research Collaboration with Hawaii:
HIV DNA in Monocytes

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014