Establish and Characterize an Acute HIV Infection Cohort in a High Risk Population

NCT00796146 | Recruiting

• 1 other identifier: SEARCH010/ RV 254
• Study Type: observational
• Target: 777
• Locations: 1 country
• Sites: 1

Brief Summary

To describe clinical, immunological, and virological characteristics of persons with acute HIV infection

1. 1.To describe demographics and behavioral risk factors for those identified with acute HIV infection
2. 2.To describe neurocognitive function and neuroimaging findings in acute HIV infection as well as describe immune response, HIV-1 genotypes and sequences in the cerebrospinal fluid.
3. 3.To describe the number and characteristics of sexual contacts
4. 4.To describe the willingness of acute HIV-infected subjects to allow the tracking of their sexual contacts for voluntary HIV counseling and testing (VCT)
5. 5.To describe immune response, HIV-1 genotypes and sequences in the genital compartment
6. 6.To describe T cell depletion in the gut mucosa in acute HIV infection and describe the changes in gut T cell during follow up
7. 7.To archive samples for future investigations including determination of viral evolution, and cell-mediated and humoral immune responses in peripheral blood and mucosal compartments

Conditions

Acute HIV Infection

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (6)

• 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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age \>18 years old
• Have protocol-defined acute HIV-1 infection (Tested 4th generation HIV EIA negative and NAT positive or tested 4th generation HIV EIA positive, negative by less sensitive EIA and NAT positive)
• Understand the study and sign informed consent form. Persons who cannot read will have the consent form read to them by a study staff and they can give informed consent by using thumb print.
• Availability for follow-up for the planned study duration

You may not qualify if:

• 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.
• Female participants who are pregnant at the time of screening

Sponsors & Collaborators

• SEARCH Research Foundation: lead
• Armed Forces Research Institute of Medical Sciences, Thailand: collaborator
• Yale University: collaborator
• Thai Red Cross AIDS Research Centre: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• University of California, San Francisco: collaborator
• National Institutes of Health (NIH): collaborator
• Johns Hopkins University: collaborator
• University of Missouri-Columbia: collaborator

Study Sites (1)

Institute of HIV Research and Innovation (IHRI)

Bangkok, Bangkok, 10330, Thailand

RECRUITING

Related Publications (9)

• 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.

  PMID: 39920714 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.

  PMID: 36162059 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.

  PMID: 34388205 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.

  PMID: 34229330 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.

  PMID: 31443253 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.

  PMID: 31180994 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.

  PMID: 30212436 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.

  PMID: 28691436 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.

  PMID: 27317797 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum, PBMC, cerebrospinal fluid, genital secretions, lymph node biopsy, Gut tissue biopsy

Study Officials

• Sandhya Vasan, MD

  US Military HIV Research Program

  STUDY CHAIR

Central Study Contacts

Nittaya Phanuphak, MD, PhD

CONTACT

6621605371; Nittaya.p@ihri.org

Nitiya Chomchey

CONTACT

66828994433; Nitiya.c@searchthailand.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director of SEARCH Research Foundation

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: April 1, 2009
• Primary Completion (Estimated): July 1, 2033
• Study Completion (Estimated): July 1, 2033
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

TH (1)