Impact of Raltegravir on the Viral Reservoirs

HIV Infection Clinical Trial

Official title:

Impact of Raltegravir on the Viral Reservoirs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01249560
• Other study ID #: 2009 A/12
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 29, 2010
• Last updated: November 29, 2010
• Start date: January 2011
• Est. completion date: March 2011

Study information

• Verified date: December 2009
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Health authority: France:AFSSAPS -french health products savety agency
• Study type: Observational

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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

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.

• Exclusion Criteria:

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

Locations

Country	Name	City	State
France	Dellamonica	Nice	Alpes Maritimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytaires and monocytaires.	OBJECTIVES; Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytes and monocytes	3 months	No
Secondary	Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytes and monocytes.	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.	3 months	No