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| Name | Class |
|---|---|
| ViiV Healthcare | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAART | Other | The proposed HAART regimen consists of:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HAART | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HIV-related clinical events | 10 years | |
| Immunologic parameters including CD4 count and CD4/CD8 ratio | 10 years | |
| Virologic parameters including HIV RNA and HIV reservoir markers | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events related to HAART initiated during acute HIV infection as assessed by DAIDS grading table version 2.1 | 10 years | |
| Adherence to ART | 10 years | |
| Frequency and functional status of HIV-specific CD8+ T cells in blood and tissue compartments (genital secretion, CSF, gut and lymph node) |
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Inclusion Criteria:
Exclusion Criteria:
1. Persons who have a history of a medical or psychiatric disorder by investigator's interview and physical examination according to standard practices, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nitiya Chomchey, RN, PhD | Contact | 66 82 899 4433 | nitiya.c@searchthailand.org | |
| Tassanee Luekasemsuk, MSc | Contact | tassanee.l@searchthailand.org |
| Name | Affiliation | Role |
|---|---|---|
| Somchai Sriplienchan, MD, MPH | SEARCH Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of HIV Research and Innovation | Recruiting | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28691436 | Derived | Ananworanich J, Eller LA, Pinyakorn S, Kroon E, Sriplenchan S, Fletcher JL, Suttichom D, Bryant C, Trichavaroj R, Dawson P, Michael N, Phanuphak N, Robb ML. Viral kinetics in untreated versus treated acute HIV infection in prospective cohort studies in Thailand. J Int AIDS Soc. 2017 Jun 26;20(1):21652. doi: 10.7448/IAS.20.1.21652. | |
| 27317797 |
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| ID | Term |
|---|---|
| D023241 | Antiretroviral Therapy, Highly Active |
| C000631408 | abacavir, dolutegravir, and lamivudine drug combination |
| ID | Term |
|---|---|
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| 10 years |
| Expression of non-specific activation markers on CD8+ T cells in blood and tissue compartments (genital secretion, CSF, gut and lymph node) | 10 years |
| HIV drug resistance by genotyping at study baseline and in case of virological failure after viral suppression. | 10 years |
| Assessment of immune activation markers by multiplex technology in blood plasma, CSF and colon and lymph node cell suspension | 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. | 10 years |
| Assessment of functional brain magnetic resonance imaging and magnetic resonance spectroscopy | 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. | 10 years |
| de Souza MS, Pinyakorn S, Akapirat S, Pattanachaiwit S, Fletcher JL, Chomchey N, Kroon ED, Ubolyam S, Michael NL, Robb ML, Phanuphak P, Kim JH, Phanuphak N, Ananworanich J; RV254/SEARCH010 Study Group. Initiation of Antiretroviral Therapy During Acute HIV-1 Infection Leads to a High Rate of Nonreactive HIV Serology. Clin Infect Dis. 2016 Aug 15;63(4):555-61. doi: 10.1093/cid/ciw365. Epub 2016 Jun 17. |