Raltegravir With Optimized Background Therapy (OBT) in Multiple Experienced HIV-infected Patients

• HIV-RNA Levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  Patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.
  
  
• HIV-RNA Levels [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.
  
  
• HIV-RNA Levels [ Time Frame: week 48 ] [ Designated as safety issue: No ]
  Patients achieving undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.
  
  
• CD4 Cells Count [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  CD4 cells count at baseline.
  
  
• CD4 Cells Count [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  CD4 cells count at week 24.
  
  
• CD4 Cells Count [ Time Frame: week 48 ] [ Designated as safety issue: No ]
  CD4 cells count at week 48.
  
  

• HIV-RNA Levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that presented undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.
  
  
• HIV-RNA Levels [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.
  
  
• HIV-RNA Levels [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  For patients in whom T20 was replaced by raltegravir it will be determined the number of patients that maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.
  
  
• CD4 Cells Count [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  For patients in whom T20 was replaced by raltegravir CD4 cells count will be assessed.
  
  
• CD4 Cells Count [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 24.
  
  
• CD4 Cells Count [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  For patients in whom T20 was replaced by raltegravir it will be assessed the median changes of CD4 cells count at week 48.
  
  
• CD4 Cells Count [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  For the HIV-2 infected patients CD4 cells count will be assessed at baseline.
  
  
• CD4 Cells Count [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  For the HIV-2 infected patients CD4 cells count will be assessed at week 24.
  
  
• CD4 Cells Count [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  For the HIV-2 infected patients CD4 cells count will be assessed at week 48.
  
  
• HIV-RNA Levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  For the HIV-2 infected patients it will be determined the number of patients with undetectable viral load (confirmed HIV RNA < 50 copies/mL) at baseline.
  
  
• HIV-RNA Levels [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 24.
  
  
• HIV-RNA Levels [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  For the HIV-2 infected patients it will be determined the number of patients that achieve or maintain undetectable viral load (confirmed HIV RNA < 50 copies/mL) at week 48.
  
  
• Adverse Drug Reactions [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  Number of participants that suffered clinical and laboratory-associated adverse events, including events that lead to discontinuations or death. Investigator will collect all drug-related adverse events, i.e. judged by the investigator to be definitely, probably, or possibly related to the study drug.
  
  

Considering its novel mechanism of action, potency, safety and tolerability, and pharmacokinetic profile, raltegravir has been used in several clinical scenarios. Since its initial clinical use in multiresistant patients throughout the Expanded Access and Compassionate Use Program (started in March 2007) raltegravir has been used successfully in other clinical scenarios, including but not limited to: enfuvirtide-related serious adverse events and intolerance, nucleoside analogue inhibitors' toxicity, ritonavir and protease inhibitor intolerance and to avoid significant drug-drug interactions. Early access to raltegravir was basically focused on patients on therapeutic failure and triple-class resistance and due to enfuvirtide intolerance. In order to achieve a better understanding of the efficacy and safety profile of raltegravir in the clinical setting, it is intended to evaluate retrospectively HIV patients treated in Portugal with raltegravir since the Early Access and Compassionate Use Program (EAP) was implemented.

This is a national, multicenter, observational, clinical cohort study with retrospective collection of data. Each site will include patients who had started treatment with raltegravir under the EAP.