BRAVO: Background Regimen of Raltegravir on Virologic Outcome (BRAVO)
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| ClinicalTrials.gov Identifier: NCT00751530 |
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Recruitment Status
:
Completed
First Posted
: September 12, 2008
Results First Posted
: June 17, 2011
Last Update Posted
: July 2, 2017
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Sponsor:
Community Research Initiative of New England
Information provided by (Responsible Party):
Community Research Initiative of New England
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| HIV Infections | Drug: raltegravir |
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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
| Group/Cohort | Intervention/treatment |
|---|---|
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Protease Inhibitor Group
Subjects who required a protease inhibitor in their new ART regimen
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Drug: raltegravir
New combination ART incorporating raltegravir with other ARVs.
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Non-protease Inhibitor
Subjects who did not take a protease inhibitor in their regimen
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Drug: raltegravir
New combination ART incorporating raltegravir with other ARVs.
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Primary Outcome Measures
:
- 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.
Secondary Outcome Measures
:
- 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.
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| 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 |
Study Population
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.
Criteria
Inclusion Criteria:
- Patients previously enrolled in the MK 0518 EAP are eligible
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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.
Information from the National Library of Medicine
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
Locations
| 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 | |
Sponsors and Collaborators
Community Research Initiative of New England
Investigators
| 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:
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HIV AIDS raltegravir |
BRAVO protease inhibitor treatment Experienced |
Additional relevant MeSH terms:
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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 |