The De-Escalate Trial: Atazanavir or Atazanavir/Ritonavir Substitution for Ritonavir Boosted PI Therapy in HIV-Infected Individuals Experiencing Ongoing HIV Viremia and Hyperlipidemia: A Randomized Controlled Pilot Study
Sponsor study identifier
Secondary identifiers
OTHER · Stanford University
OTHER · Stanford University
interventional
60
1 country
1
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2007
Actual (reported)Study Completion
March 2009
Actual (reported)The study is looking to compare the impact of lipid levels and HIV viral loads between three different drug regimens: Continuing current regimen (ritonavir boosted regimen), Switching to Atazanavir, or Switching to Atazanavir in combination to Ritonavir.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 8, 2005
Actual (reported)September 12, 2005
Actual (reported)April 2007
Actual (reported)March 2009
Actual (reported)Compare the three arms (ATV, ATV/r and continued ritonavir boosted-PI) in the following primary endpoint: % subjects who have normal serum lipid profile off lipid lowering agents and maintain CD4 counts > 75% of baseline line values.
48 weeks
% subjects with serum lipids within normal limits at week 48 off of any lipid lowering agent.
48 weeks
% subjects who maintain CD4 counts > 75% of baseline values at week 48.
48 weeks
Compare the change in CD4 count and CD4 % at 24 and 48 weeks between the three study arms.1.2.4Compare HIV plasma viral load profile over 24 and 48 weeks as DAVG between the three study arms.
24 and 48 weeks
Compare lipid profile over 48 weeks, change in total cholesterol, TC/HDL ratio and triglycerides.
48 weeks
Compare the evolution of genotypic and phenotypic drug resistance over 12 and 48 weeks between the three arms.
12 and 48 weeks
300 mg with ritonavir boosting or 400 mg without
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Stanford University School of Medicine
Stanford, California, 94305, United States
Andrew R Zolopa
Stanford University
60 participants (actual enrollment reported by the registry).
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
PRINCE: Study of Atazanavir (ATV)/Ritonavir (RTV)
Contact the study team to confirm eligibility.
Primary Completion
April 2007
Actual (reported)Study Completion
March 2009
Actual (reported)Last Updated
July 21, 2011
Record last verified: 2011-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: