BRAVO: Background Regimen of Raltegravir on Virologic Outcome
BRAVO
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
1 other identifier
observational
442
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2008
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 11, 2008
CompletedFirst Posted
Study publicly available on registry
September 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2009
CompletedResults Posted
Study results publicly available
June 17, 2011
CompletedJuly 2, 2017
July 1, 2012
1.3 years
September 11, 2008
July 22, 2010
June 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 Weeks
Secondary Outcomes (4)
Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12
12 weeks
CD4 Cell Changes Among Participants in PI vs Non-PI Group
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)
Baseline
Percentage of Participants Using Etravirine in Background Regimen
Background regimen (no specific time frame)
Study Arms (2)
Protease Inhibitor Group
Subjects who required a protease inhibitor in their new ART regimen
Non-protease Inhibitor
Subjects who did not take a protease inhibitor in their regimen
Interventions
New combination ART incorporating raltegravir with other ARVs.
Eligibility Criteria
The study population consists of individuals who were previously enrolled in raltegravir expanded access program(EAP) and completed at least 8 weeks of treatment with raltegravir, whose chart from EAP program is available for review, and whose resistance testing prior to initiation of raltegravir is available.
You may qualify if:
- 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
You may not qualify if:
- Patient did not receive approved raltegravir dose of 400 mg BID for at least 8 weeks.
- Patient chart not available for review.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Light Source Medical
Los Angeles, California, 900036, United States
AIDS Healthcare Foundation
Los Angeles, California, 90028, United States
Synergy Hematology and Oncology
Los Angeles, California, 90036, United States
Quest Clinical Research
San Francisco, California, 94115, United States
Connecticut Health Care Group
Glastonbury, Connecticut, 06033, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009, United States
Capital Medical Associates PC
Washington D.C., District of Columbia, 20036, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612, United States
Community Research Initiative
Boston, Massachusetts, 02215, United States
Community Research Initiative - West
Springfield, Massachusetts, 01107, United States
Infectious Diseases and HIV Medicine Immunodeficiency Clinic
Buffalo, New York, 14215, United States
Bellman, MD
New York, New York, 10003, United States
Mounzer, MD
Philadelphia, Pennsylvania, 19107, United States
Dr. Nicholaos C. Bellos & Associates
Dallas, Texas, 75204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Project Manager
- Organization
- Community Research Initiative
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Skiest, MD
Community Research Initiative
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2008
First Posted
September 12, 2008
Study Start
March 1, 2008
Primary Completion
June 15, 2009
Study Completion
June 15, 2009
Last Updated
July 2, 2017
Results First Posted
June 17, 2011
Record last verified: 2012-07