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BRAVO: Background Regimen of Raltegravir on Virologic Outcome

This study is currently recruiting participants.
Verified by Community Research Initiative of New England, September 2008

Sponsored by: Community Research Initiative of New England
Information provided by: Community Research Initiative of New England
ClinicalTrials.gov Identifier: NCT00751530
  Purpose

This is a retrospective chart review of participants in expanded access program that will compare virologic response in regimens not containing a protease inhibitor in the antiretroviral background regimen with regimens containing a protease inhibitor in the background regimen.


Condition
HIV

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Raltegravir   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, 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

Further study details as provided by Community Research Initiative of New England:

Primary Outcome Measures:
  • To assess virologic outcomes of raltegravir in conjunction with background antiretroviral (ART) regimens not containing a protease inhibitor (PI).

Secondary Outcome Measures:
  • To compare outcomes of raltegravir containing ART regimens without a PI to those with a PI.
  • To assess the CD4 cell count response to Raltegravir
  • To assess potential predictors of virologic outcome including, activity of ART in background ART regimen, baseline VL and CD4, number of new ARTs in OBT regimen
  • To study the clinical consequences of raltegravir virologic failure in patients continuing to receive raltegravir, CD4 trajectory following loss of virologic response, viral load trajectory following loss of virologic response

Estimated Enrollment:   400

Groups/Cohorts
1
2

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.

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  • 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751530

Contacts
Contact: Anne Habel, BS     617-502-1712     ahabel@crine.org    

Locations
United States, California
Quest Clinical Research     Recruiting
      San Francisco, California, United States, 94115
      Contact: Zach         zach@questclinical.com    
      Principal Investigator: Jay Lalezari, MD            
Synergy Hematology and Oncology     Recruiting
      Los Angeles, California, United States, 90036
      Contact: Christine Marion     310-866-0490     christine@kenmarresearch.com    
      Principal Investigator: Michael Gottlieb, MD            
AIDS Healthcare Foundation     Recruiting
      Los Angeles, California, United States, 90028
      Contact: Zenaida Vasquez     818-380-2626     zenaida.vasquez@aidshealth.org    
      Principal Investigator: Homayoon Khanlou, MD            
Light Source Medical     Recruiting
      Los Angeles, California, United States, 900036
      Contact: Helen Abad, MA     323-954-1072 ext 224     habad@lightsourcemedical.com    
      Principal Investigator: Peter J Ruane, MD            
United States, Connecticut
Connecticut Health Care Group     Recruiting
      Glastonbury, Connecticut, United States, 06033
      Contact: Delia Hernandez, RN     860-657-0764     dhernandez@ctcg.com    
      Principal Investigator: Kenneth Abriola, MD            
United States, District of Columbia
Dupont Circle Physicians Group     Recruiting
      Washington, District of Columbia, United States, 20009
      Contact: Linda G Kirkman     202-745-0201 ext 17     research@dupontdocs.com    
      Principal Investigator: Douglas Ward, MD            
United States, Florida
Orlando Immunology Center     Recruiting
      Orlando, Florida, United States, 32803
      Contact: Janiza Veloz     407-647-3960     jveloz@oicorlando.com    
      Principal Investigator: Edwin DeJesus, MD            
United States, Illinois
Ruth M. Rothstein CORE Center     Recruiting
      Chicago, Illinois, United States, 60612
      Contact: Sonia Vibhakar, PharmD     312-572-4654     svibhakar@corecenter.org    
      Principal Investigator: Dave Barker, MD            
United States, Massachusetts
Community Research Initiative     Recruiting
      Boston, Massachusetts, United States, 02215
      Contact: Jodi Jensen, RN     617-502-1716     jjensen@crine.org    
      Principal Investigator: Calvin Cohen, MD            
Community Research Initiative - West     Recruiting
      Springfield, Massachusetts, United States, 01107
      Contact: Frances Santiago, RN     413-734-2264 ext 206     fsantiago@crine.org    
      Principal Investigator: Daniel Skiest, MD            
United States, New York
Bellman, MD     Recruiting
      New York, New York, United States, 10003
      Contact: Shur Singh     212-677-2611     studycoordinator99@yahoo.com    
      Principal Investigator: Paul C Bellman, MD            
United States, Pennsylvania
Mounzer, MD     Recruiting
      Philadelphia, Pennsylvania, United States, 19107
      Contact: Karam Mounzer, MD     215-985-4448        
      Principal Investigator: Karam Mounzer, MD            

Sponsors and Collaborators
Community Research Initiative of New England

Investigators
Principal Investigator:     Daniel Skiest, MD     Community Research Initiative    
  More Information


Responsible Party:   CRI ( Daniel J. Skiest, M.D., Principal Investigator )
Study ID Numbers:   07-11
First Received:   September 11, 2008
Last Updated:   September 11, 2008
ClinicalTrials.gov Identifier:   NCT00751530
Health Authority:   United States: Institutional Review Board

Keywords provided by Community Research Initiative of New England:
HIV  
AIDS  
raltegravir  
BRAVO  
protease inhibitor  

Study placed in the following topic categories:
HIV Infections
Acquired Immunodeficiency Syndrome

ClinicalTrials.gov processed this record on October 06, 2008




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