Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07665060

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

HIV

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Sensitivity 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, defined as VL >50 copies/mL versus <=50 copies/mL.

  2. 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, defined as VL >50 copies/mL versus <=50 copies/mL.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Bill and Melinda Gates Foundation

Registry information

Official study title

Assessing HIV Antibody Increases Following Viral Rebound in People Receiving Antiretroviral Therapy

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.