Microparticles, Vector of Genetic Information During HIV Infection

NCT ID: NCT01687452

Last Updated: 2014-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-03-31

Brief Summary

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The aim of the investigators study is to demonstrate in healthy subjects and a cohort of patients infected with HIV, the presence of miRNAs in circulating peripheral blood microparticles (MPs).

Detailed Description

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Conditions

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HIV,

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Groupe A

Infected by the HIV Innocents of antiretroviral treatment, with a viral plasmatique load \> 1000 copies / ml

Group Type EXPERIMENTAL

Blood samples

Intervention Type BIOLOGICAL

group B

Infected by the HIV whith antiretroviral treatment for at least 6 months,, with a viral plasmatique load \> 40 copies / ml

Group Type EXPERIMENTAL

Blood samples

Intervention Type BIOLOGICAL

group C

Healthy volunteers

Group Type PLACEBO_COMPARATOR

Blood samples

Intervention Type BIOLOGICAL

Interventions

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Blood samples

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age of 40 +/-10 years
* Seronegativity for the HIV 2
* Patients of the group A: seropositivity for the HIV 1 confirmed in ELISA and Western Blot for at least 2 years and having never received from antiretroviral treatment, with a viral plasmatique load \> 1000 copies / ml
* Patients of the group B: seropositivity for the HIV 1 confirmed in ELISA and Western Blot for at least 2 years and under stable antiretroviral treatment for at least 6 months, with a viral load undetectable plasmatique (\< 40 copies / ml)
* patients of the group C : Matching on the age (+/-3 years) to a patient
* Be considered healthy by the Investigator after a clinical examination Seronegativity for the HIV 1 confirmed in ELISA the day of the taking

Exclusion Criteria

group A et B

* Age of \< 30 years and \> in 50 years
* Seropositivity for the HIV 2

group C Seropositivity for the HIV 2

\- Be under medicinal treatment
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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BERNARD BELAIGUES

Role: STUDY_DIRECTOR

Assistance Publique hôpitaux de Marseille

Locations

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Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2010-25

Identifier Type: OTHER

Identifier Source: secondary_id

2011-A00015-36

Identifier Type: -

Identifier Source: org_study_id

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