Monitoring HIV-infected volunteers after treatment interruption

Is this trial a fit for you?

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

What this trial studies

This observational study focuses on the safety of HIV-infected individuals who have completed research protocols involving an analytic treatment interruption (ATI). Participants, diagnosed with HIV during early infection and previously treated with antiretroviral therapy (ART), will be monitored for clinical and laboratory outcomes after their ATI. The study aims to track those who choose to remain off ART and those who may need to resume it, ensuring close monitoring of their health status over a period of up to 144 weeks. Optional procedures may include various biopsies and fluid collections to gather more data on their condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Man or woman aged ≥18 years.
* Enrolled in RV254 study.
* Completed clinical research protocol that included ATI within one month of enrollment in this protocol.
* Able and willing to provide written informed consent or, in the case of illiteracy, witnessed verbal informed consent with documentation of a thumbprint in lieu of a signature.
* Able to participate in study visits for up to 144 weeks.
* Willing to have photo or fingerprint taken for identification purposes.
* Female-specific criteria: Agrees not to become pregnant while not receiving ART. If a woman is sexually active and has no history of hysterectomy or tubal ligation or menopause, she must agree to engage in abstinence, use a prescription birth control method or use a barrier birth control method while not receiving ART.

Exclusion Criteria:

* History of a medical or psychiatric condition that, in the opinion of investigator, would jeopardize the safety or rights of the subject, such as a condition that would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.

Where it's running

• Search
  Bangkok, Bangkok, Thailand Recruiting

Study contacts

• Principal investigator: Somchai Sriplienchan, MD, MPH — SEARCH Research Foundation
• Study coordinator: Somchai Sriplienchan, MD, MPH
• Email: somchai.s@searchthailand.org

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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.