HIV Antibody Increases Following Viral Rebound in People Receiving Antiretroviral Therapy

NCT07665060 | Active Not Recruiting

• 1 other identifier: 25-A0-00-1015925
• Study Type: observational
• Target: 6,100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to Month 26 (T3)

Secondary Outcomes (2)

• Sensitivity of Antibody Level Changes

  Up to Month 26 (T3)

• Specificity of Antibody Level Changes

  Up to Month 26 (T3)

Study Arms (2)

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).

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• Anna Bershteyn, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)