Status:
COMPLETED
BRAVO: Background Regimen of Raltegravir on Virologic Outcome
Lead Sponsor:
Community Research Initiative of New England
Conditions:
HIV Infections
Eligibility:
All Genders
16+ years
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 ba...
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 w...
Eligibility Criteria
Inclusion
- 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
- Patient did not receive approved raltegravir dose of 400 mg BID for at least 8 weeks.
- Patient chart not available for review.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2009
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT00751530
Start Date
March 1 2008
End Date
June 15 2009
Last Update
July 2 2017
Active Locations (15)
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1
Light Source Medical
Los Angeles, California, United States, 900036
2
AIDS Healthcare Foundation
Los Angeles, California, United States, 90028
3
Synergy Hematology and Oncology
Los Angeles, California, United States, 90036
4
Quest Clinical Research
San Francisco, California, United States, 94115