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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01687452
Other study ID # 2011-A00015-36
Secondary ID 2010-25
Status Completed
Phase N/A
First received March 31, 2011
Last updated August 29, 2014
Start date March 2011
Est. completion date March 2012

Study information

Verified date August 2014
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 30 Years to 50 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Biological:
Blood samples


Locations

Country Name City State
France Assistance Publique Hopitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary NUMBER OF miRNAs 2 YEARS No
Secondary Demonstrate the presence of miRNAs in microparticles 2 YEARS No