Antiretroviral Therapy for Acute and Chronic HIV Infection

Phase 3

Recruiting

• Conditions: Acute HIV Infection; Chronic HIV Infection
• Interventions: Drug: HAART

• Registration Number: NCT00796263
• Lead Sponsor: SEARCH Research Foundation

Brief 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 infection (SEARCH 013 protocol 'Characteristics of immunity in gut mucosa, spinal fluid, lymph node and blood of HIV negative and HIV positive Thais').

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 Timeline

• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Study Start: 2009-05-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-06-04
• Primary Completion: 2033-06
• Study Completion: 2033-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HAART	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

Primary Outcome Measures

Name	Time	Method
HIV-related clinical events	10 years
Immunologic parameters including CD4 count and CD4/CD8 ratio	10 years
Virologic parameters including HIV RNA and HIV reservoir markers	10 years

Secondary Outcome Measures

Name	Time	Method
Adverse events related to HAART initiated during acute HIV infection as assessed by DAIDS grading table version 2.1	10 years
Adherence to ART	10 years
Assessment of functional brain magnetic resonance imaging and magnetic resonance spectroscopy	10 years
Frequency and functional status of HIV-specific CD8+ T cells in blood and tissue compartments (genital secretion, CSF, gut and lymph node)	10 years
Expression of non-specific activation markers on CD8+ T cells in blood and tissue compartments (genital secretion, CSF, gut and lymph node)	10 years
HIV drug resistance by genotyping at study baseline and in case of virological failure after viral suppression.	10 years
Assessment of immune activation markers by multiplex technology in blood plasma, CSF and colon and lymph node cell suspension	10 years
Determination of Z-score of 4 neuropsychological tests of motor and processing speed, the so-called NPZ4 score.	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.
Assessment of impact of co-morbid infections on CD4 count, CD4/CD8 ratio and HIV VL	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.

Trial Locations

Locations (1)

Institute of HIV Research and Innovation; 🇹🇭 Bangkok, Thailand