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: November 29, 2010
Last verified: December 2009
  Purpose

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.


Condition Phase
HIV Infection
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Raltegravir on the Viral Reservoirs

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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


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
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

hiv +

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249560

Locations
France
Dellamonica Not yet recruiting
Nice, Alpes Maritimes, France, 06200
Contact: SERINI MARIE ANGE, CRA    04 92039022    serini.ma@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: ROGER pierre marie, med chu nice
  More Information

No publications provided

Responsible Party: DELLAMONICA, REDPIT
ClinicalTrials.gov Identifier: NCT01249560     History of Changes
Other Study ID Numbers: 2009 A/12
Study First Received: November 29, 2010
Last Updated: November 29, 2010
Health Authority: France:AFSSAPS -french health products savety agency

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014