Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment
A Multicenter, Open-label, Randomized Study to Assess the Metabolics, Efficacy, and Safety of Once-daily Darunavir Versus Atazanavir in HIV-infected Treatment-naive Adult Patients
2 other identifiers
interventional
68
1 country
15
Brief Summary
The purpose of this research study is to compare changes in triglyceride and other lipids (levels of fats found in the blood) from Baseline (Day 1) to Week 12 for darunavir/ritonavir 800/100 mg once daily versus atazanavir/ritonavir 300/100 mg once daily in combination with a fixed-dose background regimen consisting of emtricitabine \[FTC\]/tenofovir \[TDF\] 200/300 mg once daily). This study will also evaluate the safety (adverse events), effectiveness, and tolerability of darunavir/ritonavir and atazanivir/ritonavir over 48 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv
Started Oct 2008
Longer than P75 for phase_4 hiv
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2008
CompletedFirst Posted
Study publicly available on registry
September 23, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedResults Posted
Study results publicly available
September 10, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedDecember 30, 2015
November 1, 2015
10 months
September 19, 2008
August 12, 2010
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12
Observed values.
Baseline, Week 12
Secondary Outcomes (15)
Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48
Baseline, Week 12 and 48
Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.
Baseline, Week 12 and 48
Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.
Baseline, Week 12 and 48
Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.
Baseline, Week 12 and 48
Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.
Baseline, Week 12 and 48
- +10 more secondary outcomes
Study Arms (2)
darunavir
EXPERIMENTALdarunavir 800 mg tablet once daily for 48 weeks,emtricitabine \[FTC\]/tenofovir \[TDF\] 200/300 mg tablet once daily for 48 weeks,ritonavir 100 mg capsule or tablet once daily for 48 weeks
atazanavir
EXPERIMENTALatazanavir 300 mg capsule once daily for 48 weeks,emtricitabine \[FTC\]/tenofovir \[TDF\] 200/300 mg once daily for 48 weeks,ritonavir 100 mg capsule or tablet once daily for 48 weeks
Interventions
Eligibility Criteria
You may qualify if:
- HIV-1 RNA of 1000 copies/mL or more
- No previous treatment with antiretroviral drugs for more than 10 days
- Demonstrated sensitivity \[Fold Change (FC) = lower Clinical Cut Off (CCO)\] to tenofovir, darunavir and atazanavir
- Demonstrated sensitivity to emtricitabine defined as absence of M184V/I mutation
- Any CD4 (Cluster of Differentiation 4) cell count
You may not qualify if:
- Body mass index \>30 kg/m2
- Laboratory parameters as follows: fasting glucose \>110 mg/dL, Low-Density Lipoprotein (LDL) cholesterol \>130 mg/dL, triglycerides \>200 mg/dL
- Presence of any currently active AIDS-defining illness
- Treatment for primary HIV infection or postexposure prophylaxis for HIV
- Patients with acute or chronic hepatitis A, B or C infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Glastonbury, Connecticut, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Hillsborough, New Jersey, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Dallas, Texas, United States
Related Publications (2)
Overton ET, Tebas P, Coate B, Ryan R, Perniciaro A, Dayaram YK, De La Rosa G, Baugh BP. Effects of once-daily darunavir/ritonavir versus atazanavir/ritonavir on insulin sensitivity in HIV-infected persons over 48 weeks: results of an exploratory substudy of METABOLIK, a phase 4, randomized trial. HIV Clin Trials. 2016 Mar;17(2):72-7. doi: 10.1080/15284336.2016.1141468.
PMID: 26917112DERIVEDGupta SK, Mi D, Liu Z, Saha C. Endothelial, inflammatory, coagulation, metabolic effects and safety of etravirine in HIV-uninfected volunteers. AIDS Patient Care STDS. 2011 Jun;25(6):327-31. doi: 10.1089/apc.2011.0011. Epub 2011 Apr 6.
PMID: 21470045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
65 subjects were enrolled/treated in the main study. 3 subjects were enrolled, randomized, not treated and excluded from analyses (n=68). An additional 18 subjects were enrolled in a substudy extension and excluded from the main analyses.
Results Point of Contact
- Title
- Vice President, Tibotec Therapeutics Clinical Affairs
- Organization
- Johnson & Johnson Pharmaceutical Research & Development
Study Officials
- STUDY DIRECTOR
Tibotec, Inc. Clinical Trial
Tibotec, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2008
First Posted
September 23, 2008
Study Start
October 1, 2008
Primary Completion
August 1, 2009
Study Completion
July 1, 2012
Last Updated
December 30, 2015
Results First Posted
September 10, 2010
Record last verified: 2015-11