The purpose for this protocol is to provide safe and effective standard ART to SEARCH 010 and SEARCH 013 participants. Participants are enrolled in an acute HIV infection study (SEARCH 010 protocol: 'Establish and characterize an acute HIV infection cohort in a Thai high-risk population') or in a study of chronic HIV infection (SEARCH 013 protocol 'Characteristics of immunity in gut mucosa, spinal fluid, lymph node and blood of HIV negative and HIV positive Thais').
To compare systemic and tissue compartments (genital secretion, CNS, gut and lymph node) outcomes among individuals who initiate HIV treatment during acute vs. chronic HIV infection. The outcomes will be compared by stages of infection and antiretroviral regimens. Participants are enrolled in an acute HIV infection study (SEARCH 010 protocol: 'Establish and characterize an acute HIV infection cohort in a Thai high-risk population') or in a study of chronic HIV infection (SEARCH 013 protocol 'Characteristics of immunity in gut mucosa, spinal fluid, lymph node and blood of HIV negative and HIV positive Thais') with the latter serving as controls for the acutely infected individuals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
900
1 (lamivudine) or 2 (lamivudine + abacavir) nuceloside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications once daily plus dolutegravir(DTG) 50 mg orally once daily
Institute of HIV Research and Innovation
Bangkok, Thailand
RECRUITINGHIV-related clinical events
Time frame: 10 years
Immunologic parameters including CD4 count and CD4/CD8 ratio
Time frame: 10 years
Virologic parameters including HIV RNA and HIV reservoir markers
Time frame: 10 years
Adverse events related to HAART initiated during acute HIV infection as assessed by DAIDS grading table version 2.1
Time frame: 10 years
Adherence to ART
Time frame: 10 years
Frequency and functional status of HIV-specific CD8+ T cells in blood and tissue compartments (genital secretion, CSF, gut and lymph node)
Time frame: 10 years
Expression of non-specific activation markers on CD8+ T cells in blood and tissue compartments (genital secretion, CSF, gut and lymph node)
Time frame: 10 years
HIV drug resistance by genotyping at study baseline and in case of virological failure after viral suppression.
Time frame: 10 years
Assessment of immune activation markers by multiplex technology in blood plasma, CSF and colon and lymph node cell suspension
Time frame: 10 years
Determination of Z-score of 4 neuropsychological tests of motor and processing speed, the so-called NPZ4 score.
The NPZ-4 score, a composite score of neuropsychological testing ranges from -2.2 to 2.1, with a mean of 0. The score is used to assess cognitive function in studies involving HIV and antiretroviral therapy. A higher score indicates better cognitive performance.
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Time frame: 10 years
Assessment of functional brain magnetic resonance imaging and magnetic resonance spectroscopy
Time frame: 10 years
Assessment of impact of co-morbid infections on CD4 count, CD4/CD8 ratio and HIV VL
The impact of syphilis and COVID-19 on CD4 count, CD4/CD8 ratio and HIV VL will be assessed during co-infection and after resolution. Given the duration of cohort follow-up, additional or new infections may be assessed for impact as incidence in the cohort increases.
Time frame: 10 years