Raltegravir Switch for Toxicity or Adverse Events

Inclusion criteria

• Patients treated with a combined antiretroviral therapy from at least 1 year
• Aged 18 years or older
• With one or more of the following conditions:

• Grade 3 or 4 Dyslipidemia
• Any Hyperglycemia
• Lipodystrophy (patient's self report, confirmed by physician's physical examination)
• Moderate/severe cardiovascular risk, defined as a calcium score higher than 40 or a Framingham score higher than 10 (estimated 10 years cardiovascular risk: 10%)
• Diarrhea (at least 3 emissions of loose stool every day for at least 3 days every week)
• With at least two HIV-RNA levels <50 copies/mL on two consecutive determinations at least 3 months apart
• With CD4 cell count >200 cells/ μL for at least 6 months and absence of any opportunistic infection or AIDS-related disease during the last year before screening.
• Who gave informed consent to the participation to the study

Exclusion criteria

• Pregnancy or breast feeding, desire of pregnancy in the short term
• Previous virological failure (two consecutive HIV-RNA levels > 50 copies/mL or a single value >1000 copies/mL) to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleoside analogues except for patients with subsequent genotypic resistance tests showing no resistance mutations to any of the study drugs.
• Previous exposure to inhibitors of HIV-1 integrase
• Previous major toxicity to any of the study drugs
• Spontaneous treatment interruptions in disagreement with the treating physician in the last year or loss to follow-up for at least 6 months, at least once in the last two years
• Current alcohol or drug abuse or any other condition which, in the judgment of the treating physician, may impair the patient's adherence to the new drug regimen and/or to the protocol's procedures
• Patients with grade 3 or 4 laboratory abnormalities at screening (except for lipid and glucose levels)