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
  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:


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 ]

Enrollment: 15
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
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: August 29, 2014
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 September 30, 2014