HIV Antibody Increases Following Viral Rebound in People Receiving Antiretroviral Therapy

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07665060
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2031
Completion
Mar 31, 2031

Study Design

Enrollment
6,100 participants (estimated)

Arms

  • Arm: Biobanked specimens - Suppressed Viral Load
    Biobanked specimens from individuals with suppressed viral load on antiretroviral therapy (ART).
  • Arm: Biobanked specimens - Unsupressed Viral Load
    Biobanked specimens from individuals without suppressed viral load on antiretroviral therapy (ART).

Primary Outcome Measure

Sensitivity of Antibody Level Changes [ Time Frame: Up to Month 26 (T3) ]

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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