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

Completed

• Conditions: Human Immunodeficiency Virus
• Interventions: Other: Blood samples

• Registration Number: NCT02532348
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-08
• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-21
• Last Update Submitted: 2015-08-21
• Study First Posted: 2015-08-25
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV Patients with antiretroviral therapy	Blood samples	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.
HIV patients without antiretroviral therapy	Blood samples	Blood samples in HIV patients never treated by antiretroviral therapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France