Impact of Raltegravir on the Viral Reservoirs

NCT01249560 | Withdrawn

• 1 other identifier: 2009 A/12
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (1)

• Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytaires and monocytaires.

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

  3 months

Secondary Outcomes (1)

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

  3 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

hiv +

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• ROGER pierre marie, med

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: November 30, 2010
• Study Start: January 1, 2011
• Primary Completion: January 31, 2011
• Study Completion: March 31, 2011
• Last Updated: June 17, 2026

Record last verified: 2009-12

Locations

FR (1)