BRAVO: Background Regimen of Raltegravir on Virologic Outcome (BRAVO)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00751530 |
Recruitment Status
:
Completed
First Posted
: September 12, 2008
Results First Posted
: June 17, 2011
Last Update Posted
: July 2, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
HIV Infections | Drug: raltegravir |
Study Type : | Observational |
Actual Enrollment : | 442 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | 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 |
Actual Study Start Date : | March 1, 2008 |
Actual Primary Completion Date : | June 15, 2009 |
Actual Study Completion Date : | June 15, 2009 |

Group/Cohort | Intervention/treatment |
---|---|
Protease Inhibitor Group
Subjects who required a protease inhibitor in their new ART regimen
|
Drug: raltegravir
New combination ART incorporating raltegravir with other ARVs.
|
Non-protease Inhibitor
Subjects who did not take a protease inhibitor in their regimen
|
Drug: raltegravir
New combination ART incorporating raltegravir with other ARVs.
|
- Percentage of Participants With Viral Load < 400 Copies /mL at Week 12. [ Time Frame: 12 Weeks ]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 ]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 ]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 ]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) ]These results report the percent of participants using Etravirine in the background regimen.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751530
United States, California | |
Light Source Medical | |
Los Angeles, California, United States, 900036 | |
AIDS Healthcare Foundation | |
Los Angeles, California, United States, 90028 | |
Synergy Hematology and Oncology | |
Los Angeles, California, United States, 90036 | |
Quest Clinical Research | |
San Francisco, California, United States, 94115 | |
United States, Connecticut | |
Connecticut Health Care Group | |
Glastonbury, Connecticut, United States, 06033 | |
United States, District of Columbia | |
Dupont Circle Physicians Group | |
Washington, D.C., District of Columbia, United States, 20009 | |
Capital Medical Associates PC | |
Washington, D.C., District of Columbia, United States, 20036 | |
United States, Florida | |
Orlando Immunology Center | |
Orlando, Florida, United States, 32803 | |
United States, Illinois | |
Ruth M. Rothstein CORE Center | |
Chicago, Illinois, United States, 60612 | |
United States, Massachusetts | |
Community Research Initiative | |
Boston, Massachusetts, United States, 02215 | |
Community Research Initiative - West | |
Springfield, Massachusetts, United States, 01107 | |
United States, New York | |
Infectious Diseases and HIV Medicine Immunodeficiency Clinic | |
Buffalo, New York, United States, 14215 | |
Bellman, MD | |
New York, New York, United States, 10003 | |
United States, Pennsylvania | |
Mounzer, MD | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Texas | |
Dr. Nicholaos C. Bellos & Associates | |
Dallas, Texas, United States, 75204 |
Principal Investigator: | Daniel Skiest, MD | Community Research Initiative |
Responsible Party: | Community Research Initiative of New England |
ClinicalTrials.gov Identifier: | NCT00751530 History of Changes |
Other Study ID Numbers: |
07-11 |
First Posted: | September 12, 2008 Key Record Dates |
Results First Posted: | June 17, 2011 |
Last Update Posted: | July 2, 2017 |
Last Verified: | July 2012 |
Keywords provided by Community Research Initiative of New England:
HIV AIDS raltegravir |
BRAVO protease inhibitor treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Raltegravir Potassium |
Protease Inhibitors HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |