Status:
COMPLETED
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
Lead Sponsor:
Tibotec, Inc
Collaborating Sponsors:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Conditions:
HIV
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
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 d...
Detailed Description
The purpose of this study is to expand our understanding of the metabolic effects of darunavir/ritonavir (DRV/r) in HIV-infected patients. This is a phase 4, multicenter, open-label, randomized (study...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00757783
Start Date
October 1 2008
End Date
July 1 2012
Last Update
December 30 2015
Active Locations (15)
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1
Los Angeles, California, United States
2
Glastonbury, Connecticut, United States
3
Washington D.C., District of Columbia, United States
4
Fort Lauderdale, Florida, United States