BRAVO: Background Regimen of Raltegravir on Virologic Outcome

Completed

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00751530

Run by

Community Research Initiative of New England

People needed

442

Starts

2008-03-01

Expected to finish

2009-06-15

Last updated by the study team

2017-07-02

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Light Source Medical — Los Angeles, California, United States
• AIDS Healthcare Foundation — Los Angeles, California, United States
• 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
• Community Research Initiative - West — Springfield, Massachusetts, United States
• Infectious Diseases and HIV Medicine Immunodeficiency Clinic — Buffalo, New York, United States
• Bellman, MD — New York, New York, United States
• Mounzer, MD — Philadelphia, Pennsylvania, United States
• Dr. Nicholaos C. Bellos & Associates — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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