Impact of Raltegravir on the Viral Reservoirs
- Conditions
- HIV Infection
- Registration Number
- NCT01249560
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- Brief Summary
The objective of the antiretroviral treatment is to inhibit the viral replication, estimated(appreciated) by the measure of the viral plasmatic load(responsibility). In this inhibition of the viral replication usually joins an immune reconstruction \[ 1 \]. Nevertheless, a viro-immunological dissociation, i.e. an undetectable viral load(responsibility) and an absence of immune reconstruction, is regularly observed. It is now turned out that an undetectable viral load(responsibility) does not correspond to the total absence of viral replication and that it is possible to detect of the intracellular pro-viral DNA . Raltegravir ®, because of its mode of action(share) inhibiting the integration of the pro-viral DNA in the chromosomes of the infected cells(units) , could decrease the intracellular reservoir of monocyte-macrophages, improve the homeostasis, so optimizing the cooperation lymphocytes T - macrophages. Several experimental data suggest that the regression of the abnormalities of cellular interactions, and the rate of apoptose abnormally raised(abnormally brought up) by cells(units) T at the patients in viro-immunological dissociation, could be obtained .
This study aims at measuring the impact of Raltegravir ® on the viral reservoirs lymphocyte and monocyte, to quantify the expression of the molecules of costimulation, the source(spring) of intercellular interactions lymphocytes - monocytes, and to measure the rate of apoptose of the cells(units) T.
- Detailed Description
20 patients will be included and followed over a period of 12 months
Population of the essay
Criteria of inclusion:
Patients from 18 years to 60 years HIV + treated(handled):
* Patients presenting an undetectable viral load(responsibility) for at least 6 months and no more than year, by the use of a tritherapy containing 2 NUC + 1 IP.
* Patients presenting an immunosuppression "average" with a rate of T CD4 understood between 350 and 500 cells(units) by ml.
* Patients known for a perfect observance.
Criteria of not inclusion:
* Preliminary Use of an inhibitor of the integrase
* Patients presenting an opportunist infection and\\or an evolutionary cancer
* Patients benefiting from a treatment by IL-2, interferon-alpha, steroids or the other medicines known to modify the immunity.
* Pregnant Women
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Patients from 18 years to 60 years HIV + treated(handled):
- Patients presenting an undetectable viral load(responsibility) for at least 6 months and no more than year, by the use of a tritherapy containing 2 NUC + 1 IP.
- Patients presenting an immunosuppression "average" with a rate of T CD4 understood between 350 and 500 cells(units) by ml.
- Patients known for a perfect observance.
Preliminary Use of an inhibitor of the integrase
- Patients presenting an opportunist infection and\or an evolutionary cancer
- Patients benefiting from a treatment by IL-2, interferon-alpha, steroids or the other medicines known to modify the immunity.
- Pregnant Women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytaires and monocytaires. 3 months OBJECTIVES
Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytes and monocytes
- Secondary Outcome Measures
Name Time Method Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytes and monocytes. 3 months Secondary objectives:
Measure the quality of the interactions lymphocytes - monocytes through the expression membranaires of the molecules of cotsimulation, the measure of proliferation, apoptose and cytokines produced via an in vitro stimulation CD3-CD28. A modulation of the cellular viral reservoirs could indeed underestimate the cellular death so schedule(program) that the profile cytokinique.
Measure the impact of Raltegravir ® at the patients presenting an undetectable viral load(responsibility) on sub-population T CD4 and T CD8.
Trial Locations
- Locations (1)
Dellamonica
🇫🇷Nice, Alpes Maritimes, France