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Simple antibody test may detect hidden HIV resurgence

NCT ID NCT07665060

Knowledge-focused Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a rapid HIV antibody test can detect when the virus rebounds in people taking antiretroviral therapy (ART). Researchers will analyze stored blood samples from 6100 HIV-positive individuals in the US and sub-Saharan Africa. They will compare antibody levels before and after viral rebound to see if the test can accurately identify those with unsuppressed virus. The goal is to find a simpler way to monitor treatment success.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple, affordable test to quickly detect when HIV virus levels rise again in people on treatment.
What could go wrong
This is a retrospective study using stored samples, not a real-world test. Results may not translate to actual clinic use, and the test may not be sensitive or specific enough.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 6,100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Investigators will test biobanked samples from the following cohorts: * Johns Hopkins Clinical Cohort (JHCC), a cohort of individuals followed at the Moore Clinic in Baltimore Maryland. * Rakai Community Cohort Study (RCCS), a general population study located in southwestern Uganda. * AIDS Linked to the IntraVenous Experience (ALIVE) Study, a cohort of individuals from Baltimore who inject drugs. * FHI360-HC, a cohort of women from Zimbabwe and Uganda who were part of a study on the impact of hormonal contraception on HIV incidence.

Ages

15 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV

Contacts and locations

Locations

  • NYU Langone Health

    New York, New York, 10016, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.