BRAVO: Background Regimen of Raltegravir on Virologic Outcome

• Percentage of Participants With Viral Load < 400 Copies /mL at Week 12. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  The HIV RNA (viral load) was measured using standard of care testing via local laboratories.
  
  

• Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  The HIV RNA (viral load) was measured using standard of care testing via local laboratories.
  
  
• CD4 Cell Changes Among Participants in PI vs Non-PI Group [ Time Frame: baseline to 24 Weeks ] [ Designated as safety issue: No ]
  CD4 cell counts were measured using standard of care testing via local laboratories.
  
  
• Baseline Genotypic Sensitivity Score (GSS). The Minimal Value Was 0 and the Maximum Values Was 5.4. (0 = Minimal to no Activity in Regimen and 5.4 = High to Maximal Activity in Regimen) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  The baseline GSS is calculated by the sum of resistance scores for each drug in the regimen. For each drug in the regimen a resistance score of 0, 0.5 or 1 was assigned for high, low or no levels of resistance, respectfully. The resistance assignment was based on either the Stanford database interpretation or presence of primary IAS mutation levels of resistance. Inclusion of maraviroc or new use of enfuvirtide in the regimen was scored a 1.0. The sum of the scores of the active drugs, not including raltegravir, constituted the baseline GSS.
  
  
• Percentage of Participants Using Etravirine in Background Regimen [ Time Frame: Background regimen (no specific time frame) ] [ Designated as safety issue: No ]
  These results report the percent of participants using Etravirine in the background regimen.
  
  

EAP charts from patients at the study sites who meet the inclusion criteria will be reviewed and data abstracted. A comparison of the response to treatment by viral load measurement with raltegravir will be compared in patients whose regimens contained a protease inhibitor (PI) with those that did not contain a PI. Other endpoints will also be assessed including percent of patients with viral loads less than 400 copies/ml, less than 50 copies/ ml, CD4 cell changes, consequences of failure of raltegravir and use of predictive parameters such as GSS and PSS.