HIV,NCT01687452
Microparticles, Vector of Genetic Information During HIV Infection
A study testing Blood samples in people with HIV,, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV,
- What is being tested?
- Blood samples
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- HIV,
- Being tested
- Blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
| Study group | Role | What they receive |
|---|---|---|
| Groupe A | Experimental | Infected by the HIV Innocents of antiretroviral treatment, with a viral plasmatique load > 1000 copies / ml Receives: Biological: Blood samples |
| group B | Experimental | Infected by the HIV whith antiretroviral treatment for at least 6 months,, with a viral plasmatique load > 40 copies / ml Receives: Biological: Blood samples |
| group C | Placebo comparator | Healthy volunteers Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
NUMBER OF miRNAs
Measured: 2 YEARS
Secondary outcomes (1)
Demonstrate the presence of miRNAs in microparticles
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV,Studies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687452
- Sponsor's protocol ID
- 2011-A00015-36
- Other IDs
- 2010-25
- Status last verified
- Aug 2014
- First submitted
- 31 Mar 2011
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microparticles, Vector of Genetic Information During HIV Infection ?
- ClinicalTrials.gov ID
- NCT01687452
- Acronym / sponsor ID
- 2011-A00015-36
- Conditions
- HIV,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Groupe A | Experimental | Biological: Blood samplesInfected by the HIV Innocents of antiretroviral treatment, with a viral plasmatique load > 1000 copies / ml |
| group B | Experimental | Biological: Blood samplesInfected by the HIV whith antiretroviral treatment for at least 6 months,, with a viral plasmatique load > 40 copies / ml |
| group C | Placebo comparator | Biological: Blood samplesHealthy volunteers |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples | Biological | Groupe A, group B, group C |
Primary outcome
NUMBER OF miRNAs
Time frame: 2 YEARS
1 secondary outcome
Demonstrate the presence of miRNAs in microparticles
Time frame: 2 YEARS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BERNARD BELAIGUES study director
Assistance Publique hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with HIV,, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NUMBER OF miRNAs (time frame: 2 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2014.