HIV Antibody Increases Following Viral Rebound in People Receiving Antiretroviral Therapy (NCT07665060) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
HIV Antibody Increases Following Viral Rebound in People Receiving Antiretroviral Therapy
United States6,100 participantsStarted 2026-04-01
Plain-language summary
The purpose of this study is to establish a proof-of-concept for whether rapid test can detect viral rebounds that occurred within a retrospective time window among PLHIV receiving ART in the United States and sub-Saharan Africa.
The objective of this study is to assess whether HIV antibody levels rise following HIV viral rebound, and the sensitivity and specificity of antibody level increases for detecting HIV viral rebounds.
The investigators will conduct a retrospective matched case-control study of individuals with or without suppressed viral load on antiretroviral therapy (ART). Biobanked specimens will be tested for antibody levels.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* HIV-positive individuals aged 15 or older at the time of ART initiation.
* Participated in HIV plasma or serum biobanking and viral load testing, with three samples after January 1, 2015 as follows:
* T1 specimen with suppressed VL and sufficient sample to conduct antibody testing.
* T2 specimen collected 1-13 months after T1, with: Cases: unsuppressed VL; Controls: suppressed VL.
* T3 specimen collected 1-13 months after T2, with sufficient sample to conduct antibody testing.
* At least one VL measurement recorded prior to T1, with:
* All VL measurements made in the year prior to T1 showing suppressed VL.
* If no VL measurements were made in the year prior to T1, the most recent VL measurement made prior to T1 showing suppressed VL.
Exclusion Criteria:
* Individuals with advanced HIV disease from 1 year prior to T1 until T3, defined as:
* CD4 cell count \<200 cells/mm3.
* Any AIDS-defining illnesses.
* Individuals with severe illness or hospitalization from 1 year prior to T1 until T3.
* Individuals with immune disorder or cancer diagnosis from 1 year prior to T1 until T3.
* Individuals with known recent infection at time of ART initiation (ART initiated within 1 year of estimated date of detectable infection).
* Individuals known to have been infected with HIV perinatally.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.