Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 and up

Comparing standard and intensive HIV treatment for early infection

Official title: Antiretroviral Therapy for Acute and Chronic HIV Infection

Run by SEARCH Research Foundation · NCT00796263 · Data updated 2026-11-12

This study is testing whether a standard HIV treatment or a stronger version works better for people who have just been diagnosed with HIV.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment900 (estimated)
SponsorSEARCH Research Foundation
Academic / other
Locations1 site (Bangkok)
StatusRecruiting
StartedMay 13, 2009
Main results expectedJune 2033
Study endsJune 2033
Registry record updatedJune 4, 2025
Trial IDNCT00796263 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older who have been diagnosed with acute HIV-1 infection and are enrolled in the SEARCH 010 protocol.

Probably not a fit

Patients with a history of medical or psychiatric disorders that may interfere with adherence to the study protocol may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effects of standard Highly Active Antiretroviral Therapy (HAART) versus mega-HAART in individuals with acute HIV infection. Participants enrolled in the SEARCH 010 protocol will be randomized to receive one of the two treatment regimens. The study will monitor immunological and virological outcomes, including HIV-1 plasma viral RNA levels and CD4 counts, as well as track adherence and any adverse events related to the treatments. The goal is to determine which treatment approach yields better health outcomes during the acute phase of HIV infection.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for individuals with acute HIV infection, potentially enhancing their long-term health outcomes.

How similar studies have gone: Previous studies have shown varying success with different HAART regimens, but this specific comparison of standard versus mega-HAART in acute HIV infection is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Institute of HIV Research and Innovation
    Bangkok, Thailand
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.