Health TrialsbyHealthPanel

Antiretroviral Therapy for Acute and Chronic HIV Infection

ConditionsAcute HIV InfectionChronic HIV Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSEARCH Research Foundation

About this trial

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').

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • HAART

    Drug

    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

Treatment groups

900 Participants
are divided into 1 treatment group
Group A: HAARTOther 1 intervention

Trial outcomes

Primary outcomes

1

HIV-related clinical events

Time frame
10 years
2

Immunologic parameters including CD4 count and CD4/CD8 ratio

Time frame
10 years
3

Virologic parameters including HIV RNA and HIV reservoir markers

Time frame
10 years

Secondary outcomes

1

Adverse events related to HAART initiated during acute HIV infection as assessed by DAIDS grading table version 2.1

Time frame
10 years
2

Adherence to ART

Time frame
10 years
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SEARCH Research Foundation

Lead sponsor

ViiV Healthcare

Collaborator

Source ClinicalTrials.gov
Apply now