Monitoring HIV-infected volunteers after treatment interruption

Safety and Virologic Outcomes After HIV Remission Trials in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection

This study is looking at the health of people with HIV who have stopped their treatment to see how they do without it and if they need to start again.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: SEARCH Research Foundation (Academic / other)
• Locations: 1 site (Bangkok, Bangkok)
• Trial ID: NCT02761200 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have completed a clinical research protocol involving ATI and are willing to participate in long-term monitoring.

Not a fit: Patients with significant medical or psychiatric conditions that could jeopardize their safety or rights may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the safety and management of HIV treatment interruptions, potentially leading to improved patient care strategies.

How similar studies have performed: While this approach is exploratory, similar studies involving treatment interruptions in HIV have shown promise, indicating potential for valuable findings.

Eligibility criteria

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 this trial is running

Bangkok, Bangkok

• Search — Bangkok, Bangkok, Thailand (Recruiting)

Study contacts

• Principal investigator: Somchai Sriplienchan, MD, MPH — SEARCH Research Foundation
• Study coordinator: Somchai Sriplienchan, MD, MPH

Conditions HIV