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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing HIV Antibody Increases Following Viral Rebound in People Receiving Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT07665060
- Acronym / sponsor ID
- 25-A0-00-1015925
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,100 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (8 listed)
- 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:
- At least one VL measurement recorded prior to T1, with:
Key exclusion criteria (7 listed)
- Individuals with advanced HIV disease from 1 year prior to T1 until T3, defined as:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of Antibody Level Changes
Time frame: Up to Month 26 (T3)
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.
Specificity of Antibody Level Changes
Time frame: Up to Month 26 (T3)
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.
2 secondary outcomes
Sensitivity of Antibody Level Changes
Time frame: Up to Month 26 (T3)
Specificity of Antibody Level Changes
Time frame: Up to Month 26 (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Bershteyn, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Antibody Level Changes (time frame: Up to Month 26 (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.