AzTrials
AzTrials

Acute HIV InfectionPhase 3AAHIVNCT00796263

Antiretroviral Therapy for Acute and Chronic HIV Infection

A Phase 3 study testing HAART in people with Acute HIV Infection and Chronic HIV Infection, run by SEARCH Research Foundation at 1 site in Thailand.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute HIV Infection, Chronic HIV Infection
What is being tested?
HAART
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
1 siteThailand
Study dates
13 May 2009to Jun 2033
Phase
Phase 3
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

Who may be able to join

  • Age ≥ 18 years old
  • Enrolled in the SEARCH 010 or 013 protocols with documentation of acute or chronic protocol defined HIV-1 infection and chooses to initiate or continue ART
  • Understand the study and sign informed consent form. Persons who cannot read will have the consent form read and explained to them by a member of the study staff and they can give informed consent by using their thumb print
  • Availability for follow-up for the planned study duration

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nitiya Chomchey, RN, PhD contact

66 82 899 4433

nitiya.c@searchthailand.org

Tassanee Luekasemsuk, MSc contact

tassanee.l@searchthailand.org

Thailand1 site, 1 recruiting

  • Institute of HIV Research and Innovation

    Bangkok, 10330

    Nitiya Chomchey, RN, PhD, 66828994433, nitiya.c@searchthailand.org

    Tassanee Luekasemsuk, MSc, tassanee.l@searchthailand.org

    Recruiting

Other trials in Thailand

About this study

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').

Read the detailed description

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.

Being tested
HAART
Keywords
Acute HIV infection, Chronic HIV infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HAARTDrug

    Also called Triumeq, Dovato

    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

Study groups in NCT00796263
Study groupRoleWhat they receive
HAARTOtherThe proposed HAART regimen consists of: * 1 or 2 nucleoside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications plus * Dolutegravir(DTG) 50 mg orally once daily
Receives: Drug: HAART

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HIV-related clinical events

    Measured: 10 years

  2. Immunologic parameters including CD4 count and CD4/CD8 ratio

    Measured: 10 years

  3. Virologic parameters including HIV RNA and HIV reservoir markers

    Measured: 10 years

Secondary outcomes (9)

  1. Adverse events related to HAART initiated during acute HIV infection as assessed by DAIDS grading table version 2.1

    Measured: 10 years

  2. Adherence to ART

    Measured: 10 years

  3. Frequency and functional status of HIV-specific CD8+ T cells in blood and tissue compartments (genital secretion, CSF, gut and lymph node)

    Measured: 10 years

  4. Expression of non-specific activation markers on CD8+ T cells in blood and tissue compartments (genital secretion, CSF, gut and lymph node)

    Measured: 10 years

  5. HIV drug resistance by genotyping at study baseline and in case of virological failure after viral suppression.

    Measured: 10 years

  6. Assessment of immune activation markers by multiplex technology in blood plasma, CSF and colon and lymph node cell suspension

    Measured: 10 years

  7. 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.

    Measured: 10 years

  8. Assessment of functional brain magnetic resonance imaging and magnetic resonance spectroscopy

    Measured: 10 years

  9. 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.

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2008 (estimated)
  2. Study start13 May 2009
  3. Primary completionJun 2033 (estimated)
  4. Study completionJun 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00796263
Sponsor's protocol ID
HAART for Acute HIV infection
Acronym
AAHIV
Status last verified
May 2025
First submitted
21 Nov 2008
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28691436

  • 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.

    PubMed 27317797

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HAART in people with Acute HIV Infection and Chronic 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 1 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 4 Jun 2025. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Nitiya Chomchey, RN, PhD (66 82 899 4433, nitiya.c@searchthailand.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV-related clinical events (time frame: 10 years). The study lists 3 primary outcomes in all. 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 NCT00796263, which also lists 2 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 4 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in