NCT07665060Active, not recruiting
HIV Antibody Increases Following Viral Rebound in People Receiving Antiretroviral Therapy
Assessing HIV Antibody Increases Following Viral Rebound in People Receiving Antiretroviral Therapy
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 6100 (estimated)
- First submitted
- 18 Jun 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Mar 2031
- Lead sponsor
- NYU Langone Health
- Diseases
- HIV
- NCT number
- NCT07665060
What you commit to
- Study type: Observational
- Planned participants: 6100
- From 1 Apr 2026 to the primary completion date, 31 Mar 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 15 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.