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

Completed · Phase 4

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT00757783

Run by

Tibotec, Inc

People needed

68

Starts

2008-10-01

Expected to finish

2012-07-01

Last updated by the study team

2015-12-30

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Glastonbury, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Hillsborough, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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