Platelets Study: Influence of the Antiretroviral Treatment on the Platelet Physiology During HIV Infection

Human Immunodeficiency Virus Clinical Trial

— PLAQUETTE  

Official title:

Platelets Study: Influence of the Antiretroviral Treatment on the Platelet Physiology During HIV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532348
• Other study ID #: 1108080
• Status: Completed
• Phase: N/A
• First received: August 20, 2015
• Last updated: August 21, 2015
• Start date: August 2011
• Est. completion date: September 2014

Study information

• Verified date: August 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Unchanged antiretroviral therapy for at least one year

• Plasmatic viral load < 40 copies/ml.

• signature of informed consent

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Other:
• Blood samples
Blood samples

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	day 1	No