aging-related inflamation in HIV-infected patients MedDRA version: 18.0 Level: LLT Classification code 10020175 Term: HIV infection with other conditions System Organ Class: 100000004862 MedDRA version: 18.0 Level: LLT Classification code 10008919 Term: Chronic HIV infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Isentress
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RALTEGRAVIR
CAS Number: 518048-05-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
Fundació Lluita contra la SIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient having a diagnosis of HIV-1 infection. 2. Age higher or equal to 60 years old. 3. Current HAART including Truvadaâ or Kivexaâ plus a ritonavir boosted PI started at least 6 months before. 4. Maintained undetectable plasma HIV-1 RNA (VL =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. History of virological failure to integrase inhibitors. 2. Suspected or documented resistance mutations to the integrase, as well as NRTI?related mutations that may impact nucleoside activity in current regimen. 3. Systemic concurrent process such as coinfection with hepatitis C or B, acute systemic infection within the last 4 months, neoplasm, chronic inflammatory process, etc. 4. Treatment with other drugs with anti-inflammatory, anticoagulant or antiplatelet effect (for instance corticosteroids, aspirin, etc?) 5. Therapy with statins within the last 6 months. 6. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare changes in IL-6 between protease inhibitors and raltegravir, with or without atorvastatin.;Secondary Objective: To compare changes between protease inhibitors and raltegravir, with or without atorvastatin, in the following parameters: - Inflammation and coagulation markers, immune senescence and immune activation levels. - Lipid and lipoprotein parameters. - Lumbar spine (L2-L4) and femoral (total femur, trochanter, femoral neck) BMD and T-scores. - Bone turnover markers. - Renal parameters To asses virological and immunological response.;Primary end point(s): Compare intergroup and intragroup changes in the inflammatory marker IL-6;Timepoint(s) of evaluation of this end point: At week 72 from week 24 to assess the effect of statin; at week 72 from baseline to assess the effect of PI or raltegravir plus statin and at week 24 from baseline to asses the effect of PI or raltegravir. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Compare intergroup and intragroup changes in the following parameters: - the inflammatory, immune and coagulation - lipid profile - lumbar and femoral BMD and t-score measured by DEXA - bone turnover markers - renal parameters Compare between groups the percentage of patients who maintain viral suppression. Compare between groups the percentage of patients who experienced virological failure. Virological failure will be defined as an increase in HIV RNA >50 copies in 2 determinations within 1 month. Compare between groups the change in CD4+/CD8+ T lymphocytes. Determination of antiretroviral resistance at the time of virological failure.;Timepoint(s) of evaluation of this end point: At week 72 from week 24 to assess the effect of statin; at week 72 from baseline to assess the effect of PI or raltegravir plus statin and at week 24 from baseline to asses the effect of PI or raltegravir. Compare between groups the percentage of patients who maintain viral suppression at week 72. Compare between groups the percentage of patients who experienced virological failure throughout the study. Compare between groups the change in CD4+/CD8+ T lymphocytes at week 72 from baseline. Determination of antiretroviral resistance at the time of virological failure and comparison with baseline. | — |
Countries
Spain
Contacts
Public ContactCRA
Fundació Lluita contra la SIDA
Outcome results
None listed