Clinical trial NCT00796263: Antiretroviral Therapy for Acute and Chronic HIV Infection
Official title: Antiretroviral Therapy for Acute and Chronic HIV Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute HIV Infection
Chronic HIV Infection
Keywords: Acute HIV infection
Chronic HIV infection
Lead sponsor: SEARCH Research Foundation
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2008-11-24
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HIV-related clinical events
timeFrame: 10 years
measure: Immunologic parameters including CD4 count and CD4/CD8 ratio
timeFrame: 10 years
measure: Virologic parameters including HIV RNA and HIV reservoir markers
timeFrame: 10 years
Secondary outcomes:
measure: Adverse events related to HAART initiated during acute HIV infection as assessed by DAIDS grading table version 2.1
timeFrame: 10 years
measure: Adherence to ART
timeFrame: 10 years
measure: Frequency and functional status of HIV-specific CD8+ T cells in blood and tissue compartments (genital secretion, CSF, gut and lymph node)
timeFrame: 10 years
measure: Expression of non-specific activation markers on CD8+ T cells in blood and tissue compartments (genital secretion, CSF, gut and lymph node)
timeFrame: 10 years
measure: HIV drug resistance by genotyping at study baseline and in case of virological failure after viral suppression.
timeFrame: 10 years
measure: Assessment of immune activation markers by multiplex technology in blood plasma, CSF and colon and lymph node cell suspension
timeFrame: 10 years
measure: Determination of Z-score of 4 neuropsychological tests of motor and processing speed, the so-called NPZ4 score.
timeFrame: 10 years
measure: Assessment of functional brain magnetic resonance imaging and magnetic resonance spectroscopy
timeFrame: 10 years
measure: Assessment of impact of co-morbid infections on CD4 count, CD4/CD8 ratio and HIV VL
timeFrame: 10 years
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Institute of HIV Research and Innovation
Study officials:
affiliation: SEARCH Research Foundation
name: Somchai Sriplienchan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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 17.