Antiretroviral Therapy for Acute and Chronic HIV Infection

Phase 3

Recruiting

• Conditions: Acute HIV Infection; Chronic HIV Infection
• Interventions: Drug: HAART

• Registration Number: NCT00796263
• Lead Sponsor: SEARCH Research Foundation

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Study Start: 2009-05-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2033-06
• Study Completion: 2033-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 722

Inclusion Criteria

1. Age ≥ 18 years old
2. 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)
3. Choose to start HAART according to protocol
4. 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.
5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HAART	HAART	The proposed HAART regimen consists of: * 2 nuceloside/nucleotide analog reverse-transcriptase inhibitor (NRTI) class medications * Dolutegravir(DTG) 50 mg orally once daily

Primary Outcome Measures

Name	Time	Method
HIV-1 plasma viral RNA measurements and CD4 counts during follow-up and after therapy	10 years

Secondary Outcome Measures

Name	Time	Method
Adverse events related to HAART	10 years
Number of HIV and non-HIV related clinical events	10 years
Resistance to antiretroviral medications	10 years
Adherence to HAART	10 years

Trial Locations

Locations (1)

Institute of HIV Research and Innovation; 🇹🇭 Bangkok, Thailand