An observational study in HIV, sponsored by NYU Langone Health. Active, not recruiting at 1 site in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by NYU Langone Health · Observational
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.
NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Investigators will test biobanked samples from the following cohorts:
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:
Exclusion Criteria:
Individuals with advanced HIV disease from 1 year prior to T1 until T3, defined as:
Biobanked specimens from individuals with suppressed viral load on antiretroviral therapy (ART).
Biobanked specimens from individuals without suppressed viral load on antiretroviral therapy (ART).
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.
Time frame: 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.
Time frame: Up to Month 26 (T3)
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.
Time frame: 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.
Time frame: Up to Month 26 (T3)
Plan to share: 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.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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NYU Langone Health