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

September 11, 2008
July 31, 2012
March 2008
Not Provided
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.
To assess virologic outcomes of raltegravir in conjunction with background antiretroviral (ART) regimens not containing a protease inhibitor (PI).
Complete list of historical versions of study NCT00751530 on ClinicalTrials.gov Archive Site
  • 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.
  • To compare outcomes of raltegravir containing ART regimens without a PI to those with a PI.
  • To assess the CD4 cell count response to Raltegravir
  • To assess potential predictors of virologic outcome including, activity of ART in background ART regimen, baseline VL and CD4, number of new ARTs in OBT regimen
  • To study the clinical consequences of raltegravir virologic failure in patients continuing to receive raltegravir, CD4 trajectory following loss of virologic response, viral load trajectory following loss of virologic response
Not Provided
Not Provided
 
BRAVO: Background Regimen of Raltegravir on Virologic Outcome
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

HIV Infections
Drug: raltegravir
New combination ART incorporating raltegravir with other ARVs.
  • Protease Inhibitor Group
    Subjects who required a protease inhibitor in their new ART regimen
    Intervention: Drug: raltegravir
  • Non-protease Inhibitor
    Subjects who did not take a protease inhibitor in their regimen
    Intervention: Drug: raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
442
June 2009
Not Provided

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00751530
07-11
No
Daniel Skiest, MD, Community Research Initiative of New England
Community Research Initiative of New England
Not Provided
Principal Investigator: Daniel Skiest, MD Community Research Initiative
Community Research Initiative of New England
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP