CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Raltegravir +1 moredrug
Likely dose
Raltegravir 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02383355
NCT02383355Phase 4Completed

Switch From an NNRTI or PI-based Regimen to a RAltegravir-based Regimen in Virologically Suppressed HIV-infected Patients: Effects on Platelet Reactivity, Platelet-monocyte Aggregation and the Inflammatory anD Thrombotic State of Monocytes

Radboud University Medical Center·interventional·Posted Mar 9, 2015·Updated Jan 10, 2019

In Brief

A Phase 4 clinical trial evaluating Raltegravir and Continuation of own regimen for HIV. Completed, enrolled 40 participants.

Detailed Summary

Cardiovascular disease (CVD) has emerged as a leading cause of morbidity and mortality in HIVinfected individuals. The precise mechanisms underlying this increased cardiovascular risk remain to be elucidated. Platelet hyperreactivity and increased platelet-monocyte aggregation (PMA) are found in HIVinfectedpatients and may contribute to the excess cardiovascular risk as platelets play a key role in the onset and progression of atherosclerosis and in acute cardiovascular events. In addition, HIV-infected individuals frequently suffer from persistent immune activation and inflammation. In a crosssectional study the investigators recently showed that individuals using a regimen containing the integrase inhibitor raltegravir have reduced platelet hyperreactivity and PMA compared to other antiretroviral regimens. Other recent studies showed that raltegravir is associated with decreased immune activation. Due to the inherent limitations of cross sectional studies, the investigators aim to expand our findings in an intervention study. The investigators will conduct a randomized control trial where the investigators switch patients to a integrase containing treatment regimen to assay possible changes in platelet function and persistent immune activation. Knowledge gathered in the proposed study can help understand and prevent cardiovascular disease in patients treated for a HIV infection by reducing platelet hyperreactivity and persistent immune activation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
Countries--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 9, 2015
Enrollment StartMar 1, 2015
Primary CompletionMar 31, 2016
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.3 years ago

Interventions

Raltegravirdrug

Raltegravir 400mg tablets administered twice daily together with continuation of their own backbone therapy

Continuation of own regimendrug

Continuation of own antiretroviral medication during the 10 weeks follow-up