Impact of Raltegravir on the Viral Reservoirs

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

HIV Infection

Clinical Trial Details

NCT number	NCT01249560
Study type	Observational
Source	Centre Hospitalier Universitaire de Nice
Contact
Status	Not yet recruiting
Phase	Phase 4
Start date	January 2011
Completion date	March 2011

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.