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CompletedNCT02641756

HIV Sequencing After Treatment Interruption to Identify the Clinically Relevant Anatomical Reservoir

In Depth Sampling and Subsequent Treatment Interruption to Identify the Anatomical Reservoir

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
University Hospital, Ghent · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The main goal of this study is to identify and characterise the anatomical component of the replication competent HIV-1 (Human Immunodeficiency Virus-1) reservoir. The investigators hypothesize that the clinically relevant HIV-1 reservoir is hiding in various but specific anatomic compartments and is able to rebound when therapy is stopped. This reservoir is probably smaller than the HIV-1 reservoir hiding in the blood but could be more transcriptional active because of its specific environment, possibly influenced by lower concentrations of the antiretroviral therapy. The current proposal will, for the first time, identify the source of the viral reservoir by phylogenetically backtracking the viral genome of the rebounding virus to the sequences of viral DNA (DeoxyriboNucleic Acid) in different anatomical compartments. The subsequent characterization of the viral reservoir markers (size, integration sites, methylation profile, stimulation and inhibition assays) will enable us to understand how this viral rebound occurred.

Conditions

Interventions

TypeNameDescription
OTHERtreatment interruption after in depth sampling under CARTThe participants will undergo in depth sampling under CART to characterise the HIV reservoir in different anatomical compartments. Subsequently an experimental viral rebound, by a brief therapy stop, will help us identify the clinically relevant viral reservoir by doing phylogenetic analysis on the rebounding virus and on the virus found in the different compartments under CART.

Timeline

Start date
2016-04-01
Primary completion
2018-07-01
Completion
2019-08-01
First posted
2015-12-29
Last updated
2021-10-07

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT02641756. Inclusion in this directory is not an endorsement.

HIV Sequencing After Treatment Interruption to Identify the Clinically Relevant Anatomical Reservoir (NCT02641756) · Clinical Trials Directory