Clinical trial NCT00751530: BRAVO: Background Regimen of Raltegravir on Virologic Outcome
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV
AIDS
raltegravir
BRAVO
protease inhibitor
treatment Experienced
Lead sponsor: Community Research Initiative of New England
Sponsor class: OTHER
First posted: 2008-09-12
Enrollment: 442
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Percentage of Participants With Viral Load < 400 Copies /mL at Week 12.
timeFrame: 12 Weeks
Secondary outcomes:
measure: Percentage of Participants With Viral Load < 75 Copies/ mL at Week 12
timeFrame: 12 weeks
measure: CD4 Cell Changes Among Participants in PI vs Non-PI Group
timeFrame: baseline to 24 Weeks
measure: 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)
timeFrame: Baseline
measure: Percentage of Participants Using Etravirine in Background Regimen
timeFrame: Background regimen (no specific time frame)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Light Source Medical
state: California
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
city: Los Angeles
country: United States
facility: Synergy Hematology and Oncology
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Glastonbury
country: United States
facility: Connecticut Health Care Group
state: Connecticut
city: Washington, D.C.
country: United States
facility: Dupont Circle Physicians Group
state: District of Columbia
city: Washington, D.C.
country: United States
facility: Capital Medical Associates PC
state: District of Columbia
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Chicago
country: United States
facility: Ruth M. Rothstein CORE Center
state: Illinois
city: Boston
country: United States
facility: Community Research Initiative
state: Massachusetts
city: Springfield
country: United States
facility: Community Research Initiative - West
state: Massachusetts
city: Buffalo
country: United States
facility: Infectious Diseases and HIV Medicine Immunodeficiency Clinic
state: New York
city: New York
country: United States
facility: Bellman, MD
state: New York
city: Philadelphia
country: United States
facility: Mounzer, MD
state: Pennsylvania
city: Dallas
country: United States
facility: Dr. Nicholaos C. Bellos & Associates
state: Texas
Study officials:
affiliation: Community Research Initiative
name: Daniel Skiest, MD
role: PRINCIPAL_INVESTIGATOR
References: