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Impact of Raltegravir on the Viral Reservoirs

Impact of Raltegravir on the Viral Reservoirs

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01249560
Enrollment
0
Registered
2010-11-30
Start date
2011-01-01
Completion date
2011-03-31
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

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

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytaires and monocytaires.3 monthsOBJECTIVES Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytes and monocytes

Secondary

MeasureTime frameDescription
Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytes and monocytes.3 monthsSecondary 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.

Contacts

PRINCIPAL_INVESTIGATORROGER pierre marie, med

Centre Hospitalier Universitaire de Nice

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026