Antiretroviral Therapy for Acute and Chronic HIV Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HAART.
- Who it may be relevant to
- Registry conditions: Acute HIV Infection, Chronic HIV Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- 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 outcome measures (9)
- Adverse events related to HAART initiated during acute HIV infection as assessed by DAIDS grading table version 2.1 [Time frame: 10 years]
- Adherence to ART [Time frame: 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]
- 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]
- HIV drug resistance by genotyping at study baseline and in case of virological failure after viral suppression. [Time frame: 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]
- Determination of Z-score of 4 neuropsychological tests of motor and processing speed, the so-called NPZ4 score. [Time frame: 10 years]
- Assessment of functional brain magnetic resonance imaging and magnetic resonance spectroscopy [Time frame: 10 years]
- Assessment of impact of co-morbid infections on CD4 count, CD4/CD8 ratio and HIV VL [Time frame: 10 years]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- Institute of HIV Research and Innovation — Bangkok
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. PMID 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 PMID 27317797
Identifiers
NCT: NCT00796263 · HAART for Acute HIV infection