Raltegravir Switch for Toxicity or Adverse Events

Phase IIb Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Tenofovir+Emtricitabine+Raltegravir or to Lamivudine+Abacavir+Raltegravir in Patients With Optimal Virological Control and Toxicity to the Current Combined Antiretroviral Regimen

This study aims to verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabine + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies needing a therapeutic switch for toxicity related issues 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)