Acute HIV InfectionNCT00796146
Establish and Characterize an Acute HIV Infection Cohort in a High Risk Population
An observational study of Acute HIV Infection, run by SEARCH Research Foundation at 1 site in Thailand.
Trial summary
To describe clinical, immunological, and virological characteristics of persons with acute HIV infection 1. To describe demographics and behavioral risk factors for those identified with acute HIV infection 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute HIV Infection
- How many people
- 777 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2009to Jul 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Institute of HIV Research and Innovation (IHRI)
Bangkok, Bangkok, 10330
Nittaya Phanuphak, MD, PhD, nittaya.p@ihri.org
Nitiya Chomchey, nitiya.c@searchthailand.org
About this study
To describe clinical, immunological, and virological characteristics of persons with acute HIV infection
- To describe demographics and behavioral risk factors for those identified with acute HIV infection
- 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.
- To describe the number and characteristics of sexual contacts
- To describe the willingness of acute HIV-infected subjects to allow the tracking of their sexual contacts for voluntary HIV counseling and testing (VCT)
- To describe immune response, HIV-1 genotypes and sequences in the genital compartment
- To describe T cell depletion in the gut mucosa in acute HIV infection and describe the changes in gut T cell during follow up
- To archive samples for future investigations including determination of viral evolution, and cell-mediated and humoral immune responses in peripheral blood and mucosal compartments
Read the detailed description
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.
- Conditions
- Acute HIV Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of HIV and non-HIV related clinical events
Measured: 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
Measured: 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
Measured: approximately 72 months to complete the study. The screening and enrollment is 48 months
number and characteristics of sexual contacts
Measured: 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)
Measured: 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
Measured: 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
Measured: approximately 72 months to complete the study. The screening and enrollment is 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startApr 2009
- Primary completionJul 2033 (estimated)
- Study completionJul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 777 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SEARCH Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Armed Forces Research Institute of Medical Sciences, Thailand, Thai Red Cross AIDS Research Centre, Yale University, National Institute of Allergy and Infectious Diseases (NIAID), University of California, San Francisco, National Institutes of Health (NIH), Johns Hopkins University, University of Missouri-Columbia
- Responsible party
- Principal investigator, Somchai Sriplienchan, MD, SEARCH Research Foundation
- Investigators
- Sandhya Vasan, MD, Study chair, US Military HIV Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796146
- Sponsor's protocol ID
- SEARCH010/ RV 254
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2008
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39920714Paul 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.
PubMed 36162059Corley 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.
PubMed 34388205Muccini 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.
PubMed 34229330Tovanabutra 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.
PubMed 31443253Chan 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.
PubMed 31180994Chintanaphol 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.
PubMed 30212436Ananworanich 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.
PubMed 28691436de 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.
PubMed 27317797
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish and Characterize an Acute HIV Infection Cohort in a High Risk Population
- ClinicalTrials.gov ID
- NCT00796146
- Acronym / sponsor ID
- SEARCH010/ RV 254
- Conditions
- Acute HIV Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 777 participants (estimated)
- Lead sponsor
- SEARCH Research FoundationUniversity, hospital or other
- Collaborators
- Armed Forces Research Institute of Medical Sciences, Thailand, Thai Red Cross AIDS Research Centre, Yale University, National Institute of Allergy and Infectious Diseases (NIAID), University of California, San Francisco, National Institutes of Health (NIH), Johns Hopkins University, University of Missouri-Columbia
- Study start
- Apr 2009 (actual)
- Primary completion
- Jul 2033 (estimated)
- Study completion
- Jul 2033 (estimated)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To describe clinical, immunological, and virological characteristics of persons with acute HIV infection
- To describe demographics and behavioral risk factors for those identified with acute HIV infection
- 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.
- To describe the number and characteristics of sexual contacts
- To describe the willingness of acute HIV-infected subjects to allow the tracking of their sexual contacts for voluntary HIV counseling and testing (VCT)
- To describe immune response, HIV-1 genotypes and sequences in the genital compartment
- To describe T cell depletion in the gut mucosa in acute HIV infection and describe the changes in gut T cell during follow up
- To archive samples for future investigations including determination of viral evolution, and cell-mediated and humoral immune responses in peripheral blood and mucosal compartments
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of HIV and non-HIV related clinical events
Time frame: It will take approximately 72 months to complete the study. The screening and enrollment is 48 months.
6 secondary outcomes
demographics and behavioral risk factors for those identified with acute HIV infection
Time frame: 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
Time frame: approximately 72 months to complete the study. The screening and enrollment is 48 months
number and characteristics of sexual contacts
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: approximately 72 months to complete the study. The screening and enrollment is 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Derived from this study: PubMed 39920714Sacdalan 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.
- Derived from this study: PubMed 36162059Paul 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.
- Derived from this study: PubMed 34388205Corley 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.
- Derived from this study: PubMed 34229330Muccini 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.
- Derived from this study: PubMed 31443253Tovanabutra 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.
- Derived from this study: PubMed 31180994Chan 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.
- Derived from this study: PubMed 30212436Chintanaphol 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.
- Derived from this study: PubMed 28691436Ananworanich 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.
- Derived from this study: PubMed 27317797de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandhya Vasan, MD study chair
US Military HIV Research Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute HIV Infection, run by SEARCH Research Foundation at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nittaya Phanuphak, MD, PhD (6621605371, Nittaya.p@ihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of HIV and non-HIV related clinical events (time frame: It will take approximately 72 months to complete the study. The screening and enrollment is 48 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00796146, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.