Antiretroviral Therapy for Acute and Chronic HIV Infection (AAHIV)

May 28, 2025 updated by: Somchai Sriplienchan, MD, SEARCH Research Foundation
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').

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. 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
  3. 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
  4. Availability for follow-up for the planned study duration

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: HAART

The 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
Drug: HAART

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:
  • Dovato
  • Triumeq

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV-related clinical events
Time Frame: 10 years
10 years
Immunologic parameters including CD4 count and CD4/CD8 ratio
Time Frame: 10 years
10 years
Virologic parameters including HIV RNA and HIV reservoir markers
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events related to HAART initiated during acute HIV infection as assessed by DAIDS grading table version 2.1
Time Frame: 10 years
10 years
Adherence to ART
Time Frame: 10 years
10 years
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
10 years
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
10 years
HIV drug resistance by genotyping at study baseline and in case of virological failure after viral suppression.
Time Frame: 10 years
10 years
Assessment of immune activation markers by multiplex technology in blood plasma, CSF and colon and lymph node cell suspension
Time Frame: 10 years
10 years
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.
10 years
Assessment of functional brain magnetic resonance imaging and magnetic resonance spectroscopy
Time Frame: 10 years
10 years
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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SEARCH Research Foundation

Collaborators

ViiV Healthcare

Investigators

  • Principal Investigator: Somchai Sriplienchan, MD, MPH, SEARCH Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2009

Primary Completion (Estimated)

June 1, 2033

Study Completion (Estimated)

June 1, 2033

Study Registration Dates

First Submitted

November 21, 2008

First Submitted That Met QC Criteria

November 21, 2008

First Posted (Estimated)

November 24, 2008

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAART for Acute HIV infection

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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