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NCT Number: NCT00796263

Antiretroviral Therapy for Acute and Chronic HIV Infection

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').

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of HIV Research and Innovation

Bangkok, 10330, Thailand

Location status: Recruiting

Location contact

Nitiya Chomchey, RN, PhD

CONTACT

[email protected]

66828994433

Somchai Sriplienchan, MD, MPH

PRINCIPAL_INVESTIGATOR

Tassanee Luekasemsuk, MSc

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: Triumeq, Dovato

Primary outcomes

  1. HIV-related clinical events

    Time frame: 10 years

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

    Time frame: 10 years

  3. Virologic parameters including HIV RNA and HIV reservoir markers

    Time frame: 10 years

Secondary outcomes

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

    Time frame: 10 years

  2. Adherence to ART

    Time frame: 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)

    Time frame: 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)

    Time frame: 10 years

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

    Time frame: 10 years

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

    Time frame: 10 years

  7. Determination of Z-score of 4 neuropsychological tests of motor and processing speed, the so-called NPZ4 score.

    Time frame: 10 years

    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.

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

    Time frame: 10 years

  9. Assessment of impact of co-morbid infections on CD4 count, CD4/CD8 ratio and HIV VL

    Time frame: 10 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nitiya Chomchey, RN, PhD

CONTACT

[email protected]

66 82 899 4433

Tassanee Luekasemsuk, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

SEARCH Research Foundation

Other

Collaborators

  • ViiV Healthcare

Registry information

Acronym: AAHIV

Important dates

Study start
2009
Primary completion
2033
Study completion
2033
First posted
Nov 24, 2008
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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