Predictors of Time to Viremia With an Analytic Treatment Interruption
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|ClinicalTrials.gov Identifier: NCT03033017|
Recruitment Status : Withdrawn (Funding c hange)
First Posted : January 26, 2017
Last Update Posted : December 4, 2017
This is a two-center study of 30 HIV-infected participants who have been on antiretroviral therapy (ART) for at least two years.
Participants will be asked to undergo LN and GALT biopsies both before and after a closely monitored analytic treatment interruption (ATI).
|Condition or disease||Intervention/treatment|
|HIV||Other: Blood Testing|
The HIV field has made a dramatic shift to an emphasis on finding a cure for HIV.
However, there is no agreed upon test of cure, or even what the definition of a cure might be. The investigator believes the most reliable test of cure will be an analytic treatment interruption (ATI) with time to viremia as a standard measure of the impact of an intervention on the degree to which the reservoir has been depleted. This is rational as modeling studies utilizing ATI data point to reservoir size as an important predictor of time to viremia(1) and other studies have shown that levels of HIV DNA(2) and cell associated HIV RNA(3) prior to starting antiretroviral therapy (ART) are associated with time-to-rebound. However, these studies used a limited sampling strategy to determine when viremia rebounded and it is likely that greater sensitivity in measures of time-to rebound will be needed to accurately assess the impact of an intervention. The investigators have tested an ATI strategy where plasma HIV is sampled three times each week and ART is resumed once the virus becomes detectable. In this small, pilot study, the investigators sampled lymph nodes, GALT, plasma, and PBMC before, during, and after the ATI and found the time-to-rebound was 14 days (range 5 to 30 days) and that total years of ART exposure was associated with the time-to-rebound (4). The investigators propose a similar study that includes more intensive blood and lymphoid tissue sampling to identify factors that predict time to-rebound to provide a necessary foundation for future studies that utilize a treatment interruption as a test of efficacy for curative interventions.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Predictors of Time to Viremia With an Analytic Treatment Interruption|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
HIV-infected on antiretroviral therapy 2 years
HIV-infected participants who have been on antiretroviral therapy (ART) for at least two years.
Other: Blood Testing
- Time to viremia [ Time Frame: Baseline to 14 days ]Time to viremia
- Change in vRNA+ and vDNA+ cells [ Time Frame: Baseline to 14 days ]measured by in situ hybridization and using quantitative image analysis to determine the frequency of + cell/gram lymphoid tissue
- SCA (Single Copy Assay) [ Time Frame: Baseline to 14 days ]performed as described in the protocol and reported as number of cells/ml plasma.
- Change in markers of immune activation [ Time Frame: Baseline to 14 days ]All measurements are the same IL1B, TNF, IL4, IL13, IL17, IL21,IL22, IL6, IL10
- Change in CD4 [ Time Frame: Baseline to 14 days ]
- Change in CD4/CD8 ratio [ Time Frame: Baseline to 14 days ]
- Polyadenylation-RT-ddPCR assay for total transcripts (TAR) [ Time Frame: Baseline to 14 days ]transcripts/million cells
- ddPCR assays for read-through, elongated, polyadenylated, and multiply-spliced (Tat-Rev) transcripts [ Time Frame: Baseline to 14 days ]reported as transcripts/million cells
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033017
|United States, California|
|University of California|
|San Francisco, California, United States|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Timothy Schacker, MD||University of Minnesota|