Microparticles, Vector of Genetic Information During HIV Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01687452
First received: March 31, 2011
Last updated: August 29, 2014
Last verified: August 2014

March 31, 2011
August 29, 2014
March 2011
March 2012   (final data collection date for primary outcome measure)
NUMBER OF miRNAs [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01687452 on ClinicalTrials.gov Archive Site
Demonstrate the presence of miRNAs in microparticles [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Microparticles, Vector of Genetic Information During HIV Infection
Microparticles, Vector of Genetic Information During HIV Infection ?

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).

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
HIV,
Biological: Blood samples
  • Experimental: Groupe A
    Infected by the HIV Innocents of antiretroviral treatment, with a viral plasmatique load > 1000 copies / ml
    Intervention: Biological: Blood samples
  • Experimental: group B
    Infected by the HIV whith antiretroviral treatment for at least 6 months,, with a viral plasmatique load > 40 copies / ml
    Intervention: Biological: Blood samples
  • Placebo Comparator: group C
    Healthy volunteers
    Intervention: Biological: Blood samples
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2012
March 2012   (final data collection date for primary outcome measure)

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

Male
30 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01687452
2011-A00015-36, 2010-25
No
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
Assistance Publique Hopitaux De Marseille
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP