Comparing standard and intensive HIV treatment for early infection
Antiretroviral Therapy for Acute and Chronic HIV Infection
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 |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SEARCH Research Foundation Academic / other |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT00796263 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bangkok
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.