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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | SEARCH Research Foundation Academic / other |
| Locations | 1 site (Bangkok) |
| Status | Recruiting |
| Started | May 13, 2009 |
| Main results expected | June 2033 |
| Study ends | June 2033 |
| Registry record updated | June 4, 2025 |
| Trial ID | NCT00796263 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
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Institute of HIV Research and Innovation
Bangkok, Thailand Recruiting
Study contacts
- Principal investigator: Somchai Sriplienchan, MD, MPH — SEARCH Research Foundation
- Study coordinator: Nitiya Chomchey, RN, PhD
- Email: nitiya.c@searchthailand.org
- Phone: 66 82 899 4433
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Combining immune-enhancing antibodies and vaccines to control HIV after early infection
This test will see if giving long-acting HIV antibodies together with therapeutic vaccines helps people who began ART during acute HIV infection control viral levels after a planned treatment interruption.
-
Cohort study on acute HIV infection and treatment outcomes
This study is testing how starting HIV treatment right after diagnosis affects the chances of long-term remission in patients and what factors might help achieve that.
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Combination broadly neutralizing HIV antibodies given with ART during acute infection to try to induce remission
This trial will try giving two HIV-specific broadly neutralizing antibodies along with starting ART to ART-naïve adults with acute HIV infection to see if it delays viral rebound and reduces the viral reservoir.
-
Characterizing acute HIV infection in high-risk individuals
This study is trying to learn more about people with early HIV infection by looking at their health, behavior, and immune responses to help improve future treatments and vaccines.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.