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

HIV Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00782808
• Other study ID #: SEARCH 011
• Status: Completed
• Phase: N/A
• First received: October 29, 2008
• Last updated: September 25, 2014
• Start date: March 2009
• Est. completion date: April 2014

Study information

• Verified date: September 2014
• Source: South East Asia Research Collaboration with Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Thailand	SEARCH Thailand	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
South East Asia Research Collaboration with Hawaii	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		After March 30, 2016	No

External Links

•   South East Asia Research Collaboration with Hawaii