Post Analytic Treatment Interruption Study
ConditionHIV
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSEARCH Research Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: volunteer who completion of a recent ATI
Trial outcomes
Primary outcomes
1
Antiretroviral therapy (ART) resumption for any reason
Time frame
96 weeksSecondary outcomes
1
Viral suppression after ART resumption
Time frame
48 weeks2
Time to viral rebound, from cessation of ART
Time frame
96 weeks3
Level of viral rebound after cessation of ART
Time frame
96 weeks4
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
Time frame
48 and 96 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
SEARCH Research Foundation
Lead sponsor
US Military HIV Research Program
Collaborator
Source ClinicalTrials.gov