NCT02532348

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2015

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

3.1 years

First QC Date

August 20, 2015

Last Update Submit

August 21, 2015

Conditions

Human Immunodeficiency Virus

Keywords

Human Immunodeficiency VirusHIVantiretroviral therapyplateletsImmune activationInflammatory state

Outcome Measures

Primary Outcomes (1)

  • 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.

    day 1

Secondary Outcomes (1)

  • sCD40L level

    day 1

Study Arms (2)

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.

Other: Blood samples

HIV patients without antiretroviral therapy

Blood samples in HIV patients never treated by antiretroviral therapy

Other: Blood samples

Interventions

Blood samplesOTHER

Blood samples

HIV Patients with antiretroviral therapyHIV patients without antiretroviral therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • Unchanged antiretroviral therapy for at least one year
  • Plasmatic viral load \< 40 copies/ml.
  • signature of informed consent

You may not qualify if:

  • Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HVC) coinfection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood specimen

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Frédéric Lucht, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2015

First Posted

August 25, 2015

Study Start

August 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations

FR(1)