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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec, Inc
• Collaborator: Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
• Treatments: Atazanavir Sulfate; Darunavir; Emtricitabine; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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