Antiretroviral Therapy for Acute and Chronic HIV Infection
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- HIV-related clinical events
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: HAART (Drug)
Outcomes
Primary Outcomes
HIV-related clinical events
Time Frame: 10 years
Immunologic parameters including CD4 count and CD4/CD8 ratio
Time Frame: 10 years
Virologic parameters including HIV RNA and HIV reservoir markers
Time Frame: 10 years
Secondary Outcomes
- 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)
- Assessment of impact of co-morbid infections on CD4 count, CD4/CD8 ratio and HIV VL(10 years)
Investigators
Somchai Sriplienchan, MD
Executive Director of SEARCH Research Foundation
SEARCH Research Foundation