Post Analytic Treatment Interruption Study

NCT02761200 | Recruiting

• 1 other identifier: SEARCH 025/RV412
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory study is designed to ensure the safety of HIV-infected volunteers who complete research protocols that include an analytic treatment interruption (ATI). This is a prospective cohort study of volunteers who were diagnosed with HIV during early acute HIV infection, treated with antiretroviral therapy (ART) and subsequently enrolled in a clinical study that included ATI. After completion of study participation that involves ATI, participants will be recruited into this study for continued clinical and laboratory monitoring.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Antiretroviral therapy (ART) resumption for any reason

  96 weeks

Secondary Outcomes (4)

• Viral suppression after ART resumption

  48 weeks

• Time to viral rebound, from cessation of ART

  96 weeks

• Level of viral rebound after cessation of ART

  96 weeks

• Detectable HIV RNA via single copy assay at various timepoints, such as weeks 48 and 96 off ART, as compared to baseline prior to ATI

  48 and 96 weeks

Study Arms (1)

volunteer who completion of a recent ATI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will recruit adults aged 18 years and older at the time of documented acute HIV infection (Fiebig stage I to V) and initiation of ART in Bangkok, Thailand, who have completed clinical research protocols that included analytic treatment interruption (ATI).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SEARCH Research Foundation: lead
• US Military HIV Research Program: collaborator

Study Sites (1)

SEARCH

Bangkok, Bangkok, 10330, Thailand

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Total blood HIV DNA at initiation of therapy predicted reservoir size after 24 weeks of aggressive ART, underscoring the importance of early initiation of ART.

Study Officials

• Somchai Sriplienchan, MD, MPH

  SEARCH Research Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Somchai Sriplienchan, MD, MPH

CONTACT

somchai.s@searchthailand.org

Nitiya Chomchey, PhD

CONTACT

nitiya.c@searchthailand.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Somchai Sriplienchan MD MPH

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 4, 2016
• Study Start: March 1, 2016
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

TH (1)