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.
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.
Study Type
OBSERVATIONAL
Enrollment
442
New combination ART incorporating raltegravir with other ARVs.
Light Source Medical
Los Angeles, California, United States
AIDS Healthcare Foundation
Los Angeles, California, United States
Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.
The HIV RNA (viral load) was measured using standard of care testing via local laboratories.
Time frame: 12 Weeks
Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12
The HIV RNA (viral load) was measured using standard of care testing via local laboratories.
Time frame: 12 weeks
CD4 Cell Changes Among Participants in PI vs Non-PI Group
CD4 cell counts were measured using standard of care testing via local laboratories.
Time frame: baseline to 24 Weeks
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)
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.
Time frame: Baseline
Percentage of Participants Using Etravirine in Background Regimen
These results report the percent of participants using Etravirine in the background regimen.
Time frame: Background regimen (no specific time frame)
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Synergy Hematology and Oncology
Los Angeles, California, United States
Quest Clinical Research
San Francisco, California, United States
Connecticut Health Care Group
Glastonbury, Connecticut, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
Capital Medical Associates PC
Washington D.C., District of Columbia, United States
Orlando Immunology Center
Orlando, Florida, United States
Ruth M. Rothstein CORE Center
Chicago, Illinois, United States
Community Research Initiative
Boston, Massachusetts, United States
...and 5 more locations