CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 42 enrolled
Drug / intervention
Raltegravir +2 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/NCT02577042
NCT02577042Phase 4Completed

Study of the Effect of Atorvastatin for Reducing "Inflaming" (Aging-related Complication) in HIV-infected Patients Older Than 45 Years Receiving a Protease Inhibitor-based Regimen Versus a Raltegravir-based Regimen

In Brief

A Phase 4 clinical trial evaluating Raltegravir, PI-based regimen, and 1 other intervention for Aging-related Inflammation in HIV-infected Patients. Completed, enrolled 42 participants across 1 site.

Detailed Summary

Physicians in charge of HIV-infected patients are increasingly being faced to previously unrecognized comorbid conditions such as atherosclerosis and cardiovascular events, loss of renal function, osteopenia/osteoporosis and bone fractures or non-AIDS-defining cancers (1-4). The incidence of these conditions seems to be higher than in the general population but there are controversial data about if these diseases appear at a younger age in HIV-infected patients. The investigators propose a strategy for treatment of elderly HIV-infected patients with a double impact on systemic inflammation and age-related co-morbidities by switching the protease inhibitors by raltegravir, a integrase inhibitor with a neutral effect on lipid and bone metabolism, and adding an statin because of their anti-inflammatory effect. For safety reasons, only patients with maintained viral suppression (documented indetectable viral load for 1 year or more), and no history of virological failure to integrase inhibitors or suspected or documented resistance mutations to the integrase or retrotranscriptase will be candidates for the study. Interleukin -6 and D-dimer are biomarkers that most strongly predict mortality in treated HIV infection and sCD14, sCD163 are soluble markers of monocyte activation that reflect a key source of inflammation and coagulation in HIV infection and predict mortality (26,27). For that reasons, these markers were chosen to determine changes on them after the introduction of the statin and the change of antiretrovirals

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 16, 2015
Enrollment StartOct 15, 2015
Primary CompletionJun 4, 2018
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.7 years ago

Interventions

Raltegravirdrug

Switching the PI by raltegravir 400mg every 12 hours, plus Kivexa or Truvada, for 24 weeks.

PI-based regimendrug

Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks.

Atorvastatindrug

Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks