Impact of Raltegravir on the Viral Reservoirs

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by Centre Hospitalier Universitaire de Nice.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT01249560

First received: November 29, 2010

Last updated: NA

Last verified: December 2009

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 29, 2010

Last Updated Date

November 29, 2010

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytaires and monocytaires. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

OBJECTIVES

Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytes and monocytes

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytes and monocytes. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Impact of Raltegravir on the Viral Reservoirs

Official Title ^ICMJE

Impact of Raltegravir on the Viral Reservoirs

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

hiv +

Condition ^ICMJE

HIV Infection

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

raltegravir

To illustrate the cause and effect relationship between the abnormalities of the distribution(casting) of the molecules of co-activation and the rate of apoptose, we compare also 2 groups: a first group of patients with a rate of apoptose normal ( n=10 ), and another group of patients having a rate of apoptose aggravated ( n=10 ).

20 eligible patients will receive their treatment to J1 and will be estimated for the residual concentration of the raltegravir ®, the antiretroviral activity, the tolerance and the observance at the treatments of the study in the visits of evaluation of M1, M2, M3, M6, M12, and / or in case of premature stop(ruling) of the try(essay). Every visit will give rise to a clinical evaluation of the patient. The arisen of unwanted events

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2011

Estimated Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01249560

Other Study ID Numbers ^ICMJE

2009 A/12

Has Data Monitoring Committee

Responsible Party

DELLAMONICA, REDPIT

Study Sponsor ^ICMJE

Centre Hospitalier Universitaire de Nice

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

ROGER pierre marie, med

chu nice

Information Provided By

Centre Hospitalier Universitaire de Nice

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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