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Sponsored by: |
South East Asia Research Collaboration with Hawaii |
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Information provided by: | South East Asia Research Collaboration with Hawaii |
ClinicalTrials.gov Identifier: | NCT00777426 |
A total of 60 participants will be enrolled. They will be in 3 groups
Condition |
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HIV Infections |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Estimated Enrollment: | 60 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2012 |
Groups/Cohorts |
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1.
Thai HAD individuals (n=20 subjects)
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2.
Thai Non-HAD individuals (n = 20 subjects)
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3.
Thai Non-infected individuals (n = 20 subjects)
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This application focuses on the role of cellular immune responses in HIV dementia (HAD) versus non-HAD individuals in a cognitively characterized cohort followed for one year. Increasing evidence links strong CD4+ T helper function to robust CD8+ CTL responses. HIV-1-infected individuals who are able to maintain strong HIV-1 specific T cell responses have better clinical outcomes and rarely develop neurological signs or symptoms. Monocyte/macrophage (M/M) infiltration into the white matter of the brain is a hallmark of HAD; however, the mechanisms by which M/M are recruited to the brain are not clearly understood. We hypothesize that the loss of specific HIV-1 T cell response results in activation/dysregulation of M/M leading to their accumulation in the brain.
To test this hypothesis will characterize Thai HIV-1-infected individuals as follows: 20 HAD individuals, 20 CD4-, education-, gender-, and age-matched non-HAD individuals and 20 HIV negativecontrols. We will then: 1) define CD4+ and CD8+ T cell function by evaluating HIV-1 specific responses in HAD vs.
non-HAD groups; 2) simultaneously correlate these responses to M/M subpopulation cell number, percentage, and immune function; 3) correlate these responses to HIV-1 proviral load and autologous viral sequences (viral escape sequences and HIV quasispecies); and 4) evaluate the impact of ARV on dementia related to changes in immunological responses. Since little is known of the interaction between CD4+ T helper responses, CTL function, and the level of M/M subpopulation activation in the neuropathogenesis of HAD, this innovative study will elucidate the role of HIV-1 specific immune responses in HAD and provide new insights into HIV-1 neuropathogenesis and its relationship to peripheral immune responses, potentially opening exciting new areas for further investigation.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
A total of 60 participants will be enrolled. They will be in 3 groups
Inclusion Criteria:
Thai HAD individuals
20 years of age
Thai Non-HAD individuals
Exclution Criteria:
The following laboratory values:
Contact: Jintanat - Ananworanich, MD | 662-254-2566 ext 101 | jintanat.a@searchthailand.org |
Contact: Somprartthana - Rattanamanee, RN | 662-254-2566 ext 106 | somprartthana.r@searchthailand.org |
Thailand, - | |
SEARCH Thailand | Recruiting |
Bangkok, -, Thailand | |
Contact: Somprartthana Rattanamanee, RN 662-254-2566 ext 106 somprartthana.r@searchthailand.org |
Principal Investigator: | Silvia Ratto Kim, Ph.D | University of Hawaii |
Responsible Party: | SEARCH ,Thailand ( Somprartthana Rattanamanee ) |
Study ID Numbers: | SEARCH 007 |
Study First Received: | October 21, 2008 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00777426 History of Changes |
Health Authority: | Thailand:Ethic committee |
HIV positive with HAD |
Virus Diseases Sexually Transmitted Diseases, Viral AIDS Dementia Complex HIV Seropositivity HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Dementia Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |