NCT00751530

BRAVO: Background Regimen of Raltegravir on Virologic Outcome

Outcomes of Early Raltegravir Experience: Comparison of Virologic Response in Regimens Not Containing a Protease Inhibitor in the Antiretroviral Background Regimen Versus a Protease Inhibitor in the Background Regimen

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 442 (actual)
• Sponsor: Community Research Initiative of New England · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This is a retrospective chart review of participants in raltegravir expanded access program and will compare virologic response in regimens not containing a protease inhibitor in the antiretroviral background regimen to regimens containing a protease inhibitor in the background regimen.

Detailed description

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	raltegravir	New combination ART incorporating raltegravir with other ARVs.

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-06-15
• Completion: 2009-06-15
• First posted: 2008-09-12
• Last updated: 2017-07-02
• Results posted: 2011-06-17

Locations

15 sites across 1 country: United States