HIVNCT07665060
HIV Antibody Increases Following Viral Rebound in People Receiving Antiretroviral Therapy
An observational study of HIV, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV
- How many people
- 6,100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 31 Mar 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing HIV Antibody Increases Following Viral Rebound in People Receiving Antiretroviral Therapy
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.
- Conditions
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Biobanked specimens - Suppressed Viral Load | Biobanked specimens from individuals with suppressed viral load on antiretroviral therapy (ART). | |
| Biobanked specimens - Unsupressed Viral Load | Biobanked specimens from individuals without suppressed viral load on antiretroviral therapy (ART). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Antibody Level Changes
Sensitivity of a given change in antibody levels from T1 to T3 for correctly classifying individuals as having unsuppressed or suppressed VL at T2. Unsuppressed VL will be defined as VL >500 copies/mL.
Measured: Up to Month 26 (T3)
Specificity of Antibody Level Changes
Specificity of a given change in antibody levels from T1 to T3 for correctly classifying individuals as having unsuppressed or suppressed VL at T2. Unsuppressed VL will be defined as VL >500 copies/mL.
Measured: Up to Month 26 (T3)
Secondary outcomes (2)
Sensitivity of Antibody Level Changes
Specificity of a given change in antibody levels from T1 to T3 for correctly classifying individuals as having unsuppressed or suppressed VL at T2, defined as VL >50 copies/mL versus <=50 copies/mL.
Measured: Up to Month 26 (T3)
Specificity of Antibody Level Changes
Specificity of a given change in antibody levels from T1 to T3 for correctly classifying individuals as having unsuppressed or suppressed VL at T2, defined as VL >50 copies/mL versus <=50 copies/mL.
Measured: Up to Month 26 (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Apr 2026
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 6,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Anna Bershteyn, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665060
- Sponsor's protocol ID
- 25-A0-00-1015925
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will not enroll participants; a study site lab will test publicly available blood samples, and investigators will use their results to estimate sensitivity and specificity of the rapid tests to detect change in HIV antibodies.