Impact of Raltegravir on the Viral Reservoirs
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| ClinicalTrials.gov Identifier: NCT01249560 |
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Recruitment Status
: Unknown
Verified December 2009 by Centre Hospitalier Universitaire de Nice.
Recruitment status was: Not yet recruiting
First Posted
: November 30, 2010
Last Update Posted
: November 30, 2010
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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 or disease |
|---|
| HIV Infection |
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 : | Observational |
| Estimated Enrollment : | 20 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Impact of Raltegravir on the Viral Reservoirs |
| Study Start Date : | January 2011 |
| Estimated Primary Completion Date : | January 2011 |
| Estimated Study Completion Date : | March 2011 |
| Group/Cohort |
|---|
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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 |
- Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytaires and monocytaires. [ Time Frame: 3 months ]
OBJECTIVES
Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytes and monocytes
- Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytes and monocytes. [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249560
| France | |
| Dellamonica | Not yet recruiting |
| Nice, Alpes Maritimes, France, 06200 | |
| Contact: SERINI MARIE ANGE, CRA 04 92039022 serini.ma@chu-nice.fr | |
| Principal Investigator: | ROGER pierre marie, med | chu nice |
| Responsible Party: | DELLAMONICA, REDPIT |
| ClinicalTrials.gov Identifier: | NCT01249560 History of Changes |
| Other Study ID Numbers: |
2009 A/12 |
| First Posted: | November 30, 2010 Key Record Dates |
| Last Update Posted: | November 30, 2010 |
| Last Verified: | December 2009 |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |