An interventional study of Antiretroviral treatment interruption in Chronic HIV-1 Infection, sponsored by Objectif Recherche Vaccins SIDA. Completed at 2 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-09-29.
Sponsored by Objectif Recherche Vaccins SIDA · Not applicable and Interventional
During the ERAMUNE-01 and -02 studies, the HIV-DNA quantification in the PBMCs (Peripheral Blood Mononuclear Cells) showed showed that some patients had a very low or undetectable reservoir.
Recent studies showed that a low reservoir is associated to a spontaneous virologic control in three specific categories of patients:
Taking into account these 3 categories of patients which common characteristics is a low reservoir, our objective is to answer the 2 following questions:
The main objective of the proof-of-concept ERAMUNE-03 trial is to evaluate the proportion of patients in success (i.e. able to maintain a virologic and an immunologic control of the infection) after treatment discontinuation, failure is defined as:
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 15 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Objectif Recherche Vaccins SIDA is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Antiretroviral treatment interruption in 3 successive groups of 5 patients. "Zero-risk" strategy If after 8 weeks of treatment interruption, at least 1 patient from group 1 does not present any of the failure criteria, patients from group 2 will be included and their treatment interrupted. If after 8 weeks of treatment interruption, at least 2 patients from groups 1 and 2 do not present any failure criteria, patients from group 3 will be included and their treatment interrupted.
Other: Antiretroviral treatment interruption
pilot study in chronically HIV-infected patients with an ultralow HIV reservoir undergoing treatment-interruption.
Proportion of patients in success
Success is defined as the maintenance of the controlled viral infection after 24 weeks of therapeutic interruption. Failure is defined as: * An HIV-1-RNA plasma viral load \> 400 copies/mL starting from Week 4 as confirmed by two consecutive measures within 2 to 4 weeks * Or a CD4 count \< 400 cells/mm3 starting from Week 4 as confirmed by two consecutive measure within 2 to 4 weeks * Or the onset of an AIDS-grading clinical event (grade B or C in the CDC classification, version 1993)
Time frame: Week 24
Changes from baseline in CD4 and CD8 lymphocytes counts
Time frame: Up to Week 48
Changes from baseline in immune activation and inflammation markers
Time frame: Up to Week 48
Changes from baseline in anti-HIV specific T cells response
Time frame: Up to Week 48
Quantitative and qualitative changes from baseline in the HIV-1 reservoir as measured on sorted CD4 lymphocytes subsets
CD4 subpopulations will be live-sorted and purified. In each subset defined by surface markers, HIV-1 DNA will be quantified and transcriptional potential of HIV will be evaluated.
Time frame: Up to Week 48
Proportion of patients in virologic success (HIV-1-RNA plasma viral load < 400 copies/mL)
Time frame: Up to Week 48
Changes from baseline in the HIV-1 reservoir as measured by HIV-1 DNA copies per million PBMCs
Time frame: Up to Week 48
Changes from baseline in the proportion of defective HIV-1 DNA
Evaluation of the stop codons in the HIV-1 DNA sequence
Time frame: Up to Week 48
Changes from baseline in the plasma concentrations of antiretroviral molecules
Time frame: Up to Week 48
Changes from baseline in the patient quality of life and in the disease-related symptoms
Time frame: Up to Week 48
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Objectif Recherche Vaccins SIDA