Human Immunodeficiency VirusPLAQUETTENCT02532348
Platelets Study: Influence of the Antiretroviral Treatment on the Platelet Physiology During HIV Infection
An observational study of Human Immunodeficiency Virus, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
HIV infection is associated with an immune activation and an inflammatory response - despite an active antiretroviral therapy - which may lead notably but not exclusively to cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Blood samples
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to Sep 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study populations: * HIV patients under 2 NRTIs (Nucleosidic analogs of Transcriptase Reverse Inhibitors) and 1 PI or 2 NRTIs and 1 NNRTI, for at least one year with a plasmatic viral load under 40 cp/ml. * Untreated HIV patients
Who may be able to join
- Unchanged antiretroviral therapy for at least one year
- Plasmatic viral load < 40 copies/ml.
- signature of informed consent
Who cannot join
- Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HVC) coinfection
Trial locations and contacts
1 site in 1 country.
About this study
HIV infection is associated with an immune activation and an inflammatory response - despite an active antiretroviral therapy - which may lead notably but not exclusively to cardiovascular diseases. It has been shown that the use of Protease Inhibitors (PI) instead of Non Nucleosidic Inhibitors (NNRTI) may increase the risk of myocardial infarction. Platelets may play a role in the occurrence of the inflammatory state: they contain big amounts of chemokines, growth factors, and adhesion proteins. Today, the contribution of platelets to the inflammatory state associated with HIV infection has been little studied. Thus, it has been shown that platelets in HIV patients are able to release interleukin (IL)-18. The group has shown with others that the platelet function could be altered during HIV infection. Inversely, it doesn't know how antiretroviral therapy interacts with platelets.
The aim of the study is to evaluate, according to the antiretroviral therapy, the impact on the platelets activation markers.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Blood samples
- Keywords
- Human Immunodeficiency Virus, HIV, antiretroviral therapy, platelets, Immune activation, Inflammatory state
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Blood samples
| Study group | Role | What they receive |
|---|---|---|
| HIV Patients with antiretroviral therapy | Blood samples in HIV patients under 2 NRTIs (Nucleosidic analogs of Transcriptase Reverse Inhibitors) and 1 PI or 2 NRTIs and 1 NNRTI, for at least one year with a plasmatic viral load under 40 cp/ml. Receives: Other: Blood samples | |
| HIV patients without antiretroviral therapy | Blood samples in HIV patients never treated by antiretroviral therapy Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmatic level of sCD40L
Comparison of plasmatic level of soluble Cluster Differentiation (sCD40L) between 2 groups : HIV patients treated by antiretroviral therapy and HIV patients untreated. sCD40L is measured by enzyme linked immunosorbent assay (ELISA) in ng/ml.
Measured: day 1
Secondary outcomes (1)
sCD40L level
Comparison of plasmatic level of sCD40L between 2 groups : patients treated with 2 Nucleosidic analogs of Transcriptase Reverse Inhibitors (NRTIs ) and 1 Protease Inhibitors (PI) and patients treated with 2 NRTIs and 1 NNRTI. sCD40L is measured by ELISA in ng/ml.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startAug 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Lucht, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532348
- Sponsor's protocol ID
- 1108080
- Acronym
- PLAQUETTE
- Status last verified
- Aug 2015
- First submitted
- 20 Aug 2015
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelets Study: Influence of the Antiretroviral Treatment on the Platelet Physiology During HIV Infection
- ClinicalTrials.gov ID
- NCT02532348
- Acronym / sponsor ID
- PLAQUETTE / 1108080
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Human Immunodeficiency Virus, HIV, antiretroviral therapy, platelets, Immune activation, Inflammatory state
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Aug 2015 (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.
HIV infection is associated with an immune activation and an inflammatory response - despite an active antiretroviral therapy - which may lead notably but not exclusively to cardiovascular diseases. It has been shown that the use of Protease Inhibitors (PI) instead of Non Nucleosidic Inhibitors (NNRTI) may increase the risk of myocardial infarction. Platelets may play a role in the occurrence of the inflammatory state: they contain big amounts of chemokines, growth factors, and adhesion proteins. Today, the contribution of platelets to the inflammatory state associated with HIV infection has been little studied. Thus, it has been shown that platelets in HIV patients are able to release interleukin (IL)-18. The group has shown with others that the platelet function could be altered during HIV infection. Inversely, it doesn't know how antiretroviral therapy interacts with platelets.
The aim of the study is to evaluate, according to the antiretroviral therapy, the impact on the platelets activation markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV Patients with antiretroviral therapy | – | Other: Blood samplesBlood samples in HIV patients under 2 NRTIs (Nucleosidic analogs of Transcriptase Reverse Inhibitors) and 1 PI or 2 NRTIs and 1 NNRTI, for at least one year with a plasmatic viral load under 40 cp/ml. |
| HIV patients without antiretroviral therapy | – | Other: Blood samplesBlood samples in HIV patients never treated by antiretroviral therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study populations: * HIV patients under 2 NRTIs (Nucleosidic analogs of Transcriptase Reverse Inhibitors) and 1 PI or 2 NRTIs and 1 NNRTI, for at least one year with a plasmatic viral load under 40 cp/ml. * Untreated HIV patients
Key inclusion criteria (3 listed)
- Unchanged antiretroviral therapy for at least one year
- Plasmatic viral load < 40 copies/ml.
- signature of informed consent
Key exclusion criteria (1 listed)
- Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HVC) coinfection
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 samplesBlood samples | Other | HIV Patients with antiretroviral therapy, HIV patients without antiretroviral therapy |
Primary outcome
Plasmatic level of sCD40L
Time frame: day 1
Comparison of plasmatic level of soluble Cluster Differentiation (sCD40L) between 2 groups : HIV patients treated by antiretroviral therapy and HIV patients untreated. sCD40L is measured by enzyme linked immunosorbent assay (ELISA) in ng/ml.
1 secondary outcome
sCD40L level
Time frame: day 1
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 25 Aug 2015.
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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.
Frédéric Lucht, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 inclusion and 1 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 25 Aug 2015. 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. 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?
Plasmatic level of sCD40L (time frame: day 1). 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 25 Aug 2015.