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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT02532348

Collaborator

(none)

133

Enrollment

Location

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus	Other: Blood samples

Study Design

Study Type:

Observational

Actual Enrollment :

133 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Blood samples
HIV patients without antiretroviral therapy Blood samples in HIV patients never treated by antiretroviral therapy	Other: Blood samples Blood samples

Arm

Intervention/Treatment

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

Blood samples

HIV patients without antiretroviral therapy

Blood samples in HIV patients never treated by antiretroviral therapy

Other: Blood samples

Blood samples

Outcome Measures

Primary Outcome Measures

Plasmatic level of sCD40L [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.

Secondary Outcome Measures

sCD40L level [day 1]
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.