BRAVO: Background Regimen of Raltegravir on Virologic Outcome

HIV Infections Clinical Trial

— BRAVO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751530
• Other study ID #: 07-11
• Status: Completed
• Phase: N/A
• First received: September 11, 2008
• Last updated: July 31, 2012
• Start date: March 2008
• Est. completion date: June 2009

Study information

• Verified date: July 2012
• Source: Community Research Initiative of New England
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• raltegravir
New combination ART incorporating raltegravir with other ARVs.

Locations

Country	Name	City	State
United States	Community Research Initiative	Boston	Massachusetts
United States	Infectious Diseases and HIV Medicine Immunodeficiency Clinic	Buffalo	New York
United States	Ruth M. Rothstein CORE Center	Chicago	Illinois
United States	Dr. Nicholaos C. Bellos & Associates	Dallas	Texas
United States	Connecticut Health Care Group	Glastonbury	Connecticut
United States	AIDS Healthcare Foundation	Los Angeles	California
United States	Light Source Medical	Los Angeles	California
United States	Synergy Hematology and Oncology	Los Angeles	California
United States	Bellman, MD	New York	New York
United States	Orlando Immunology Center	Orlando	Florida
United States	Mounzer, MD	Philadelphia	Pennsylvania
United States	Quest Clinical Research	San Francisco	California
United States	Community Research Initiative - West	Springfield	Massachusetts
United States	Capital Medical Associates PC	Washington	District of Columbia
United States	Dupont Circle Physicians Group	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Community Research Initiative of New England

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.	The HIV RNA (viral load) was measured using standard of care testing via local laboratories.	12 Weeks	No
Secondary	Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12	The HIV RNA (viral load) was measured using standard of care testing via local laboratories.	12 weeks	No
Secondary	CD4 Cell Changes Among Participants in PI vs Non-PI Group	CD4 cell counts were measured using standard of care testing via local laboratories.	baseline to 24 Weeks	No
Secondary	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)	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.	Baseline	No
Secondary	Percentage of Participants Using Etravirine in Background Regimen	These results report the percent of participants using Etravirine in the background regimen.	Background regimen (no specific time frame)	No