Phase 4
N=42
Study of the Effect of Atorvastatin for Reducing Aging-related Complication in HIV-infected Patients Older Than 45 Years Receiving a Protease Inhibitor-based Regimen Versus a Raltegravir-based Regimen
Aging-related Inflammation in HIV-infected Patients
Bottom Line
View on ClinicalTrials.gov: NCT02577042 ↗Enrolled (actual)
42
Serious AEs
7.1%
Results posted
Jun 2020
Primary outcome: Primary: Changes in the Inflammatory Marker IL-6 — 42.5; 40.0; 39.3; 41.1 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Raltegravir (Drug); PI-based regimen (Drug); Atorvastatin (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Inflammatory Marker IL-6 |
42.5; 40.0; 39.3; 41.1; 43.2; 41.7 | — |
| PRIMARY Changes in Plasma Soluble Markers (D-dimer) |
1743; 1990; 1844; 1917; 2051; 1868 | — |
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
Eligibility Criteria
Inclusion Criteria
- Patient having a diagnosis of HIV-1 infection.
- Age 45 years old.
- Current highly active antiretroviral therapy including Truvada or Kivexa plus a ritonavir boosted PI started at least 3 months before.
- Maintained undetectable plasma HIV-1 RNA (VL < 50 copies/mL) for at least 12 months.
- Voluntary written informed consent.
Exclusion Criteria
- History of virological failure to integrase inhibitors.
- Suspected or documented resistance mutations to the integrase, as well as NRTI-related mutations that may impact nucleoside activity in current regimen.
- Systemic concurrent process such as coinfection with hepatitis C or B, acute systemic infection within the last 4 months, neoplasm, chronic inflammatory process, etc.
- Treatment with other drugs with anti-inflammatory, anticoagulant or antiplatelet effect (for instance corticosteroids, aspirin, etc…)
- Therapy with statins within the last 6 months.
Data sourced from ClinicalTrials.gov (NCT02577042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.