BRAVO: Background Regimen of Raltegravir on Virologic Outcome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Skiest, MD, Community Research Initiative of New England
ClinicalTrials.gov Identifier:
NCT00751530
First received: September 11, 2008
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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 Intervention
HIV Infections
Drug: raltegravir

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of Participants With Viral Load < 400 Copies /mL at Week 12. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    These results report the percent of participants using Etravirine in the background regimen.


Enrollment: 442
Study Start Date: March 2008
Study Completion Date: June 2009
Groups/Cohorts Assigned Interventions
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.

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
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, see Learn About Clinical Studies.

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

Locations
United States, California
Synergy Hematology and Oncology
Los Angeles, California, United States, 90036
AIDS Healthcare Foundation
Los Angeles, California, United States, 90028
Light Source Medical
Los Angeles, California, United States, 900036
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
Capital Medical Associates PC
Washington, District of Columbia, United States, 20036
Dupont Circle Physicians Group
Washington, District of Columbia, United States, 20009
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
  More Information

No publications provided

Responsible Party: Daniel Skiest, MD, Principal Investigator, Community Research Initiative of New England
ClinicalTrials.gov Identifier: NCT00751530     History of Changes
Other Study ID Numbers: 07-11
Study First Received: September 11, 2008
Results First Received: July 22, 2010
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014