BRAVO: Background Regimen of Raltegravir on Virologic Outcome

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Patients previously enrolled in the MK 0518 EAP are eligible
Patients not enrolled in the MK 0518 EAP (or other Raltegravir protocols) but who meet the specific EAP protocol entry criteria are eligible:
- Age >= 16 years
- Limited or no treatment options due to resistance or intolerance to multiple antiretroviral regimens, documented resistance to at least one drug in each of the 3 classes of oral ARTs (NRTI, NNRTI, PI) by genotype or phenotype testing, intolerance defined as having had a clinically significant adverse event which in the opinion of the clinician provides a contraindication to the use of any drug in that class iii. Patient did not achieve virologic suppression on ART regimen prior to receipt of raltegravir iv. Patient was clinically stable at time of initiation of raltegravir, eg. clinical status and all chronic medications (except ARTs) unchanged for >= 2 weeks prior to raltegravir receipt.
Patient received raltegravir for at least 8 weeks
Baseline and week 8 or later HIV viral load done and available for review
Resistance test (either genotypic or phenotypic test) available prior to receipt of raltegravir

Exclusion Criteria

Patient did not receive approved raltegravir dose of 400 mg BID for at least 8 weeks.
Patient chart not available for review.

Arm && Interventions

Group	Intervention	Description
Protease Inhibitor Group	raltegravir	Subjects who required a protease inhibitor in their new ART regimen
Non-protease Inhibitor	raltegravir	Subjects who did not take a protease inhibitor in their regimen

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.	12 Weeks	The HIV RNA (viral load) was measured using standard of care testing via local laboratories.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12	12 weeks	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	baseline to 24 Weeks	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)	Baseline	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	Background regimen (no specific time frame)	These results report the percent of participants using Etravirine in the background regimen.

Locations (15): Dr. Nicholaos C. Bellos & Associates
🇺🇸
Dallas, Texas, United States
Light Source Medical
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Los Angeles, California, United States
Quest Clinical Research
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San Francisco, California, United States
Synergy Hematology and Oncology
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Los Angeles, California, United States
Orlando Immunology Center
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Orlando, Florida, United States
Connecticut Health Care Group
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Glastonbury, Connecticut, United States
Dupont Circle Physicians Group
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Washington, D.C., District of Columbia, United States
Capital Medical Associates PC
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Washington, D.C., District of Columbia, United States
Ruth M. Rothstein CORE Center
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Chicago, Illinois, United States
Community Research Initiative
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Boston, Massachusetts, United States
Community Research Initiative - West
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Springfield, Massachusetts, United States
Mounzer, MD
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Philadelphia, Pennsylvania, United States
Infectious Diseases and HIV Medicine Immunodeficiency Clinic
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Buffalo, New York, United States
Bellman, MD
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New York, New York, United States
AIDS Healthcare Foundation
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Los Angeles, California, United States