Antiretroviral Therapy for Acute and Chronic HIV Infection

Study Overview
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Brief Summary
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This is a protocol designed to randomize subjects with acute HIV infection to receive standard HAART or mega-HAART for subject who are enrolled in SEARCH 010 study (protocol title: Establish and characterize an acute HIV infection cohort in a Thai high risk population. To describe the impact of standard HAART versus mega-HAART initiated during the acute HIV infection period on immunological and virological outcomes.

Detailed Description
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HIV-1 plasma viral RNA measurements and CD4 counts during follow-up and after therapy Number of HIV and non-HIV related clinical events Adverse events related to HAART Adherence to HAART Resistance to antiretroviral medications

Official Title
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Antiretroviral Therapy for Acute and Chronic HIV Infection

Conditions
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Acute HIV Infection, Chronic HIV Infection

Intervention / Treatment
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* Drug: HAART


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Enrolled in SEARCH 010 protocol and have protocol-defined acute HIV-1 infection (Tested 4th generation HIV EIA negative and NAT positive or tested 4th generation HIV EIA positive, negative by less sensitive EIA and NAT positive) Choose to start HAART according to protocol Understand the study and sign informed consent form. Persons who cannot read will have the consent form read to them by a study staff and they can give informed consent by using 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HAART<br>The proposed HAART regimen consists of: 2 nuceloside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications Dolutegravir(DTG) 50 mg orally once daily | Drug: HAART<br>* 2 nuceloside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications or Kivexa (ABC300/3TC300) orally once daily Dolutegravir(DTG) 50 mg orally once daily<br>* Other names: Tivicay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV-1 plasma viral RNA measurements and CD4 counts during follow-up and after therapy |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of HIV and non-HIV related clinical events |  | 10 years | 
| Adverse events related to HAART |  | 10 years | 
| Adherence to HAART |  | 10 years | 
| Resistance to antiretroviral medications |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute HIV infection, Chronic HIV infection