- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01687452
Microparticles, Vector of Genetic Information During HIV Infection
August 29, 2014 updated by: Assistance Publique Hopitaux De Marseille
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Groupe A
Infected by the HIV Innocents of antiretroviral treatment, with a viral plasmatique load > 1000 copies / ml
|
|
Experimental: group B
Infected by the HIV whith antiretroviral treatment for at least 6 months,, with a viral plasmatique load > 40 copies / ml
|
|
Placebo Comparator: group C
Healthy volunteers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
NUMBER OF miRNAs
Time Frame: 2 YEARS
|
2 YEARS
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Demonstrate the presence of miRNAs in microparticles
Time Frame: 2 YEARS
|
2 YEARS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
March 31, 2011
First Submitted That Met QC Criteria
September 18, 2012
First Posted (Estimate)
September 19, 2012
Study Record Updates
Last Update Posted (Estimate)
September 1, 2014
Last Update Submitted That Met QC Criteria
August 29, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-A00015-36
- 2010-25 (Other Identifier: AP HM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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