Clinical trial NCT01249560: Impact of Raltegravir on the Viral Reservoirs
Official title: Impact of Raltegravir on the Viral Reservoirs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infection
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hiv +

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

Eligibility 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

Primary outcomes:
measure: Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytaires and monocytaires.
timeFrame: 3 months
Secondary outcomes:
measure: Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytes and monocytes.
timeFrame: 3 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Dellamonica
state: Alpes Maritimes
Study officials:
affiliation: CHU NICE
name: ROGER pierre marie, med
role: PRINCIPAL_INVESTIGATOR
References: