Microparticles, Vector of Genetic Information During HIV Infection
2 other identifiers
interventional
15
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv
Started Mar 2011
Shorter than P25 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Posted
Study publicly available on registry
September 19, 2012
CompletedSeptember 1, 2014
August 1, 2014
1 year
March 31, 2011
August 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
NUMBER OF miRNAs
2 YEARS
Secondary Outcomes (1)
Demonstrate the presence of miRNAs in microparticles
2 YEARS
Study Arms (3)
Groupe A
EXPERIMENTALInfected by the HIV Innocents of antiretroviral treatment, with a viral plasmatique load \> 1000 copies / ml
group B
EXPERIMENTALInfected by the HIV whith antiretroviral treatment for at least 6 months,, with a viral plasmatique load \> 40 copies / ml
group C
PLACEBO COMPARATORHealthy volunteers
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
BERNARD BELAIGUES
Assistance Publique hôpitaux de Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2011
First Posted
September 19, 2012
Study Start
March 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
September 1, 2014
Record last verified: 2014-08