Phase 4 Completed N=65 Randomized Treatment

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

Source: ClinicalTrials.gov NCT00757783 ↗

Enrolled (actual)

Serious AEs

16.7%

Results posted

Sep 2010

Primary outcomePrimary: Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12 — 113.7; 114.2; 22.0; 8.1 milligram per deciliters (mg/dL)

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12	113.7; 114.2; 22.0; 8.1	—
SECONDARY Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48	141.8; 165.1; 20.3; 4.6; 22.3; 11.8	—
SECONDARY Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.	84.6; 100.2; 13.6; 9.6; 14.7; 13.9	—
SECONDARY Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.	37.9; 45.0; 6.6; 2.2; 6.0; 3.7	—
SECONDARY Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.	1.1; 1.3; 0.1; -0.007; 0.1; 0.0	—
SECONDARY Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.	0.7; 0.8; -0.004; -0.05; 0.0; 0.0	—
SECONDARY Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.	4.1; 3.9; -0.1; -0.1; 0.1; -0.1	—
SECONDARY Change From Baseline in Glucose at Week 12 and 48.	88.5; 89.7; 1.5; 5.8; 2.8; 6.4	—
SECONDARY Change From Baseline in Insulin at Week 12 and 48.	5.96; 8.59; -1.07; 0.70; 0.95; -2.88	—
SECONDARY Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48.	1.624; 2.943; -0.483; 0.105; 0.035; -1.236	—
SECONDARY Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.	13; 19; 28; 29; 25; 22	—
SECONDARY Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)	13; 19; 28; 28; 25; 22	—
SECONDARY Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.	5.016; 4.562; -2.955; -2.605; -3.269; -2.902	—
SECONDARY Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.	268.3; 326.7; 111.1; 68.3; 217.4; 205.3	—
SECONDARY Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).	268.3; 326.7; 103.4; 74.6; 194.9; 187.7	—
SECONDARY Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).	18.6; 21.4; 5.9; 4.5; 9.6; 8.5	—

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT00757783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.