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Microparticles, Vector of Genetic Information During HIV Infection

Primary Purpose

HIV,

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV,

Eligibility Criteria

30 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Groupe A

group B

group C

Arm Description

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

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

Healthy volunteers

Outcomes

Primary Outcome Measures

NUMBER OF miRNAs

Secondary Outcome Measures

Demonstrate the presence of miRNAs in microparticles

Full Information

First Posted
March 31, 2011
Last Updated
August 29, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01687452
Brief Title
Microparticles, Vector of Genetic Information During HIV Infection
Official Title
Microparticles, Vector of Genetic Information During HIV Infection ?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV,

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Groupe A
Arm Type
Experimental
Arm Description
Infected by the HIV Innocents of antiretroviral treatment, with a viral plasmatique load > 1000 copies / ml
Arm Title
group B
Arm Type
Experimental
Arm Description
Infected by the HIV whith antiretroviral treatment for at least 6 months,, with a viral plasmatique load > 40 copies / ml
Arm Title
group C
Arm Type
Placebo Comparator
Arm Description
Healthy volunteers
Intervention Type
Biological
Intervention Name(s)
Blood samples
Primary Outcome Measure Information:
Title
NUMBER OF miRNAs
Time Frame
2 YEARS
Secondary Outcome Measure Information:
Title
Demonstrate the presence of miRNAs in microparticles
Time Frame
2 YEARS

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

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Microparticles, Vector of Genetic Information During HIV Infection

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