Antiretroviral Therapy for Acute and Chronic HIV Infection
AAHIV
1 other identifier
interventional
900
1 country
1
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').
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2009
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2008
CompletedFirst Posted
Study publicly available on registry
November 24, 2008
CompletedStudy Start
First participant enrolled
May 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2033
June 4, 2025
May 1, 2025
24.1 years
November 21, 2008
May 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (9)
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
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
- +4 more secondary outcomes
Study Arms (1)
HAART
OTHERThe 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SEARCH Research Foundationlead
- ViiV Healthcarecollaborator
Study Sites (1)
Institute of HIV Research and Innovation
Bangkok, 10330, Thailand
Related Publications (2)
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: 28691436DERIVEDde 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 17.
PMID: 27317797DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Somchai Sriplienchan, MD, MPH
SEARCH Research Foundation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Director of SEARCH Research Foundation
Study Record Dates
First Submitted
November 21, 2008
First Posted
November 24, 2008
Study Start
May 13, 2009
Primary Completion (Estimated)
June 1, 2033
Study Completion (Estimated)
June 1, 2033
Last Updated
June 4, 2025
Record last verified: 2025-05