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

NCT00782808 | Completed

• 1 other identifier: SEARCH 011
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV DNA in Monocytes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1 HIV DNA will be stratified by high

2 HIV DNA will be stratified by low

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SEARCH Research Foundation: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

SEARCH Thailand

Bangkok, Thailand

Location

Related Publications (1)

• Corley MJ, Sacdalan C, Pang APS, Chomchey N, Ratnaratorn N, Valcour V, Kroon E, Cho KS, Belden AC, Colby D, Robb M, Hsu D, Spudich S, Paul R, Vasan S, Ndhlovu LC; SEARCH010/RV254 and SEARCH013/RV304 study groups. Abrupt and altered cell-type specific DNA methylation profiles in blood during acute HIV infection persists despite prompt initiation of ART. PLoS Pathog. 2021 Aug 13;17(8):e1009785. doi: 10.1371/journal.ppat.1009785. eCollection 2021 Aug.

  PMID: 34388205 DERIVED

Related Links

• South East Asia Research Collaboration with Hawaii

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Victor Valcour, MD

  University of Hawii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: March 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

TH (1)