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| Name | Class |
|---|---|
| Armed Forces Research Institute of Medical Sciences, Thailand | OTHER_GOV |
| Thai Red Cross AIDS Research Centre | OTHER |
| Yale University | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) |
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To describe clinical, immunological, and virological characteristics of persons with acute HIV infection
This study will establish an acute infection cohort which is predominantly non-subtype B. Description of the early events in HIV infection is critical to HIV vaccine development and understanding HIV-1 immunopathogenesis. The ability to establish this cohort and identify individuals with acute HIV-1 infection would provide the basis for future hypothesis-driven proposals.
Subjects will be recruited at the TRCARC. Subjects seeking VCT will be asked to provide contact information. Blood samples, either plasma or whole blood collected on filter paper (dried blood spots, or DBS) will be screened for acute HIV infection by pooled or individual NAT if non-reactive after screening by an EIA capable of detecting both HIV antibody and antigen (4th generation or sensitive EIA). Additionally, 4th generation reactive samples will be screened with a non-IgM sensitive EIA capable of detecting HIV antibody only (less sensitive EIA) within 1-2 days of sample collection. Those who are found to have acute HIV infection will be asked to enroll in the cohort study. These acute HIV-infected participants will be followed prospectively at week 0, day 2, 3, 5, 7, 10 then weeks 2, 4, 8, 12, 16, 20, 24, then every 12 weeks until the end of the study (maximum of 192 weeks of follow up). Subjects will receive blood testing for CD4, HIV RNA, ALT, creatinine and lipids, and urinalysis. Subjects will be asked to complete a questionnaire on HIV risk behavior. Archiving of plasma and PBMC for future immunologic and virologic testing will be performed. Optional study procedures include 1) collection of genital secretions 2) collection of cerebrospinal fluid 3) brain MRI/MRS without gadolinium 4) sampling of gut-associated lymphoid tissue by colon biopsy 5) genetic testing 6) tracking of and offering VCT to sexual contacts of acute HIV-infected subjects. Subjects are encouraged to be hospitalized for the first 3-7 days for post-procedural observation and for ease of follow up.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of HIV and non-HIV related clinical events | It will take approximately 72 months to complete the study. The screening and enrollment is 48 months. |
| Measure | Description | Time Frame |
|---|---|---|
| demographics and behavioral risk factors for those identified with acute HIV infection | approximately 72 months to complete the study. The screening and enrollment is 48 months | |
| neurocognitive function and neuroimaging findings in acute HIV infection as well as describe immune response, HIV-1 genotypes and sequences in the cerebrospinal fluid |
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Inclusion Criteria:
Exclusion Criteria:
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The population seeking VCT at the TRCAC will be screened. They are comprised of both men and women of different ages, economic stratus and education level: a large portion of whom are at high risk for HIV infection through commercial sex work and MSM.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nittaya Phanuphak, MD, PhD | Contact | 6621605371 | Nittaya.p@ihri.org | |
| Nitiya Chomchey | Contact | 66828994433 | Nitiya.c@searchthailand.org |
| Name | Affiliation | Role |
|---|---|---|
| Sandhya Vasan, MD | US Military HIV Research Program | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of HIV Research and Innovation (IHRI) | Recruiting | Bangkok | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39920714 | Derived | Sacdalan C, Austin C, Varma A, Pinyakorn S, Kroon E, Colby DJ, Chan P, Goh O, Pornpaisakul K, Intasan J, Luekasemsuk T, Robb ML, Chomchey N, Phanuphak N, Ananworanich J, Vasan S, Hsu D; SEARCH 010/RV254 study group. Impaired creatinine-based estimated glomerular filtration rate in Thai individuals switching to dolutegravir: illustrating the role of cystatin C testing to aid clinical decision making. AIDS Res Ther. 2025 Feb 7;22(1):15. doi: 10.1186/s12981-025-00712-0. | |
| 36162059 |
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| NIH |
| University of California, San Francisco | OTHER |
| National Institutes of Health (NIH) | NIH |
| Johns Hopkins University | OTHER |
| University of Missouri-Columbia | OTHER |
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serum, PBMC, cerebrospinal fluid, genital secretions, lymph node biopsy, Gut tissue biopsy
| approximately 72 months to complete the study. The screening and enrollment is 48 months |
| number and characteristics of sexual contacts | approximately 72 months to complete the study. The screening and enrollment is 48 months |
| the willingness of acute HIV-infected subjects to allow the tracking of their sexual contacts for voluntary HIV counseling and testing (VCT) | approximately 72 months to complete the study. The screening and enrollment is 48 months |
| immune response, HIV-1 genotypes and sequences in the genital compartment | approximately 72 months to complete the study. The screening and enrollment is 48 months |
| T cell depletion in the gut mucosa in acute HIV infection and describe the changes in gut T cells during follow up | approximately 72 months to complete the study. The screening and enrollment is 48 months |
| Derived |
| Paul R, Cho K, Bolzenius J, Sacdalan C, Ndhlovu LC, Trautmann L, Krebs S, Tipsuk S, Crowell TA, Suttichom D, Colby DJ, Premeaux TA, Phanuphak N, Chan P, Kroon E, Vasan S, Hsu D, Carrico A, Valcour V, Ananworanich J, Robb ML, Ake JA, Sriplienchan S, Spudich S; RV254/SEARCH 010 Study Team. Individual Differences in CD4/CD8 T-Cell Ratio Trajectories and Associated Risk Profiles Modeled From Acute HIV Infection. Psychosom Med. 2022 Oct 1;84(8):976-983. doi: 10.1097/PSY.0000000000001129. Epub 2022 Jul 6. |
| 34388205 | Derived | 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. |
| 34229330 | Derived | Muccini C, Pinyakorn S, Sirivichayakul S, Kroon E, Sacdalan C, Crowell TA, Trichavaroj R, Ananworanich J, Vasan S, Phanuphak N, Colby DJ; RV254 Study Group. Brief Report: Prevalence Trend of Transmitted Drug Resistance in a Prospective Cohort of Thai People With Acute HIV Infection. J Acquir Immune Defic Syndr. 2021 Aug 15;87(5):1173-1177. doi: 10.1097/QAI.0000000000002718. |
| 31443253 | Derived | Tovanabutra S, Sirijatuphat R, Pham PT, Bonar L, Harbolick EA, Bose M, Song H, Chang D, Oropeza C, O'Sullivan AM, Balinang J, Kroon E, Colby DJ, Sacdalan C, Hellmuth J, Chan P, Prueksakaew P, Pinyakorn S, Jagodzinski LL, Sutthichom D, Pattamaswin S, de Souza M, Gramzinski RA, Kim JH, Michael NL, Robb ML, Phanuphak N, Ananworanich J, Valcour V, Kijak GH, Sanders-Buell E, Spudich S; MHRP Viral Sequencing Core; RV254/SEARCH 010 Study Team. Deep Sequencing Reveals Central Nervous System Compartmentalization in Multiple Transmitted/Founder Virus Acute HIV-1 Infection. Cells. 2019 Aug 15;8(8):902. doi: 10.3390/cells8080902. |
| 31180994 | Derived | Chan P, Dumrongpisutikul N, Subra C, Colby DJ, Kroon E, Fletcher J, Sacdalan C, Phanuphak N, Valcour V, Ananworanich J, Trautmann L, Spudich S. Neurosyphilis During Acute HIV Infection: A CNS Immunologic and Virologic Characterization. J Acquir Immune Defic Syndr. 2019 Oct 1;82(2):e34-e37. doi: 10.1097/QAI.0000000000002114. No abstract available. |
| 30212436 | Derived | Chintanaphol M, Sacdalan C, Chottanapund S, Pinyakorn S, Buranapraditkun S, Crowell TA, Kroon E, Manasnayakorn S, Chipman JG, Schacker TW, Michael N, Phanuphak N, Spudich SS, Colby DJ, Ananworanich J. Brief Report: Safety and Tolerability of Inguinal Lymph Node Biopsy in Individuals With Acute HIV Infection in Thailand. J Acquir Immune Defic Syndr. 2018 Oct 1;79(2):244-248. doi: 10.1097/QAI.0000000000001780. |
| 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 | Derived | 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. |