BRAVO: Background Regimen of Raltegravir on Virologic Outcome

NCT ID: NCT00751530

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 442 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-01
• Study Completion Date: 2009-06-15

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.

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.

Conditions

HIV Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Protease Inhibitor Group

Subjects who required a protease inhibitor in their new ART regimen

raltegravir

Intervention Type: DRUG

New combination ART incorporating raltegravir with other ARVs.

Non-protease Inhibitor

Subjects who did not take a protease inhibitor in their regimen

raltegravir

Intervention Type: DRUG

New combination ART incorporating raltegravir with other ARVs.

Interventions

raltegravir

New combination ART incorporating raltegravir with other ARVs.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Community Research Initiative of New England

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Skiest, MD

Role: PRINCIPAL_INVESTIGATOR

Community Research Initiative

Locations

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

Countries

United States

Other Identifiers

07-11

Identifier Type: -

Identifier Source: org_study_id