HIV
Conditions
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.
Interventions
None listed
Sponsors
NYU Langone Health
Bill and Melinda Gates Foundation
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Antibody Level Changes | 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. |
| Specificity of Antibody Level Changes | 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
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Antibody Level Changes | 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. |
| Specificity of Antibody Level Changes | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnna Bershteyn, PhD
NYU Langone Health
Outcome results
None listed