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Microparticles, Vector of Genetic Information During HIV Infection

This study is currently recruiting participants.
Verified September 2012 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01687452
First received: March 31, 2011
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

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).


Condition Intervention
HIV,
 Biological: Blood samples

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Microparticles, Vector of Genetic Information During HIV Infection ?

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • NUMBER OF miRNAs [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demonstrate the presence of miRNAs in microparticles [ Time Frame: 2 YEARS ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Groupe A
Infected by the HIV Innocents of antiretroviral treatment, with a viral plasmatique load > 1000 copies / ml
 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
 Biological: Blood samples
Placebo Comparator: group C
Healthy volunteers
 Biological: Blood samples

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687452

Contacts
Contact: patrice ROLL patrice.roll@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: patrice ROLL         patrice.roll@ap-hm.fr    
Principal Investigator: patrice ROLL            
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01687452     History of Changes
Other Study ID Numbers: 2011-A00015-36, 2010-25
Study First Received: March 31, 2011
Last Updated: September 18, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 22, 2013