HIV-1 Specific Immune Responses in Thai Individuals With HIV Dementia

NCT00777426 | Completed DMC

• 1 other identifier: SEARCH 007
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 60 participants will be enrolled. They will be in 3 groups

1. 1.ARV-naïve, HIV-positive ≥ 20 year of age with HAD (n=25) who intend to start ARV
2. 2.ARV-naïve, HIV-positive ≥ 20 year of age without HAD (n=25), who intend to start ARV
3. 3.HIV-negative ≥ 20 year of age (n=10). The protocol team will work with the primary care physician to ensure that the subjects receive standard HIV and 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 positive with HAD

Outcome Measures

Primary Outcomes (1)

• Assess the HIV-1 specific CD4+ T helper cell and CD8+ CTL responses in individuals with and without HAD prior to initiation of ARV

  May 2013

Secondary Outcomes (2)

• Measure M/M dysregulation/activation and correlate this with HIV-1 specific CD4+ and CD8+ T cell responses prior to initiation of ARV

  May 2013

• Correlate the impact of ARV on HAD with qualitative and quantitative changes in CD4+ and CD8+ HIV-1 specific responses

  May 2013

Study Arms (3)

Thai HAD individuals (25 cases)

Thai Non-HAD individuals (25 cases)

Thai Non-infected individuals (10 cases)

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

A total of 60 participants will be enrolled. They will be in 3 groups 1. ARV-naïve, HIV-positive ≥ 20 year of age with HAD (n=25) who intend to start ARV 2. ARV-naïve, HIV-positive ≥ 20 year of age without HAD (n=25), who intend to start ARV 3. HIV-negative ≥ 20 year of age (n=10). The protocol team will work with the primary care physician to ensure that the subjects receive standard HIV and ARV care; however, initiation of ARV is not a requirement of the study and ARV will not be provided by the study.

You may qualify if:

• Group Thai HAD individuals
• years of age
• not currently receiving nor have ever received antiretroviral medications
• Group Thai Non-HAD individuals
• will be matched with a seropositive Thai patient with similar age (same decade), education (less than high school degree, high school degree +/- some college, college degree +), gender, and CD4 group
• HIV positive
• not currently receiving nor have ever received antiretroviral medications.
• Group Thai Non-HAD individuals will be matched with a Thai seronegative patient by age (same decade), and education (less than high school degree, high school degree +/- some college, college degree+), and gender.

You may not qualify if:

• Head injury with loss of consciousness greater than 1 hour
• Current or past illicit drug use (less then 5 years) or positive drug screen for amphetamine, methamphetamines, cocaine, marijuana, or narcotics at either screening or entry.
• Inability to provide informed consent or lack of designated surrogate who can provide consent
• The following laboratory values:
• 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 to entry, persistent and active AIDS- defining opportunistic infection or autoimmune disease. Stable treated opportunistic infections on maintenance therapy, minor infections such as oral thrush and Kaposi's Sarcoma limited to the skin will be allowed.
• Current or recent fevers or meningeal signs suggestive of CNS opportunistic infection.\*
• History of pre-existing neurologic disease to include stroke, multiple sclerosis
• History of psychiatric illness including schizophrenia, bipolar disorder, anxiety disorder, panic attacks, or post traumatic stress disorder. Patients with active major depression will be excluded as well - patients with past depression that is controlled and patients with or minor depressive symptoms will be allowed to enroll.
• Known learning disability including dyslexia.
• Positive Hepatitis C serology (Hepatitic C Ab)
• Confusion or other signs and symptoms of metabolic encephalopathy or delirium

Sponsors & Collaborators

• SEARCH Research Foundation: lead

Study Sites (1)

SEARCH Thailand

Bangkok, Bangkok, 10330, Thailand

Location

Related Links

• South East Asia Research Collaboration with Hawaii (SEARCH)

Biospecimen

Retention: SAMPLES WITHOUT DNA

PBMC, Plasma, Urine

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

• Jintanat Ananworanich, MD

  SEARCH Research Foundation

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

TH (1)