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Report for Clinical Trial NCT00757783

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT00757783 HIV

6 Interventions

Name: ritonavir

Description: 100 mg capsule or tablet once daily for 48 weeks
Type: Drug
Group Labels: 1

darunavir

Name: ritonavir

Description: 100 mg capsule or tablet once daily for 48 weeks
Type: Drug
Group Labels: 1

atazanavir

Name: darunavir

Description: 800 mg tablet once daily for 48 weeks
Type: Drug
Group Labels: 1

darunavir

Name: emtricitabine [FTC]/tenofovir [TDF]

Description: 200/300 mg tablet once daily for 48 weeks
Type: Drug
Group Labels: 1

darunavir

Name: emtricitabine [FTC]/tenofovir [TDF]

Description: 200/300 mg once daily for 48 weeks
Type: Drug
Group Labels: 1

atazanavir

Name: atazanavir

Description: 300 mg capsule once daily for 48 weeks
Type: Drug
Group Labels: 1

atazanavir


Primary Outcomes

Description: Observed values.

Measure: Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12

Time: Baseline, Week 12

Secondary Outcomes

Description: Observed Values

Measure: Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48

Time: Baseline, Week 12 and 48

Description: Observed Values

Measure: Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.

Time: Baseline, Week 12 and 48

Description: Observed Values

Measure: Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.

Time: Baseline, Week 12 and 48

Description: Observed Values

Measure: Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.

Time: Baseline, Week 12 and 48

Description: Observed Values

Measure: Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.

Time: Baseline, Week 12 and 48

Description: Participants TC and HDL was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was calculated as ratio using observed values.

Measure: Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.

Time: Baseline, Week 12 and 48

Description: Participants glucose level was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was reported.

Measure: Change From Baseline in Glucose at Week 12 and 48.

Time: Baseline, Week 12 and 48

Description: Participants insulin was analyzed at Baseline and Week 12 and 48 and change from Baseline at Week 12 and 48 were reported.

Measure: Change From Baseline in Insulin at Week 12 and 48.

Time: Baseline, Week 12 and 48

Description: Participants homeostasis model assessment-insulin resistance (HOMA-IR) were observed and change from Baseline were reported. HOMA-IR score was calculated as: (fasting plasma glucose*fasting serum insulin)/22.5. Low HOMA IR values indicate high insulin sensitivity and high HOMA IR values indicate low insulin sensitivity (insulin resistance).

Measure: Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48.

Time: Baseline, Week 12 and 48

Description: Number of Participants with antiviral activity, human immunodeficiency virus Type 1 (HIV-1) RNA less than (<) 50 copies per milliliters (copies/mL) or < 400 copies/mL.

Measure: Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.

Time: Week 12 and 48

Description: Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed.

Measure: Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)

Time: Week 12 and 48

Description: the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values.

Measure: Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.

Time: Baseline, Week 12 and 48

Description: Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed.

Measure: Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.

Time: Baseline, Week 12 and 48

Description: Participants' Cluster of Differentiation (CD) 4 Cell Count were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.

Measure: Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).

Time: Baseline, Week 12 and 48

Description: Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.

Measure: Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).

Time: Baseline, Week 12 and 48

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 M184V

Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed.. Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.. the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values.. Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.. Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed.. Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).. Participants' Cluster of Differentiation (CD) 4 Cell Count were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.. Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).. Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.. 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 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 HIV The purpose of this study is to expand our understanding of the metabolic effects of darunavir/ritonavir (DRV/r) in HIV-infected patients. --- M184V ---

Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed.. Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.. the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values.. Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.. Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed.. Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).. Participants' Cluster of Differentiation (CD) 4 Cell Count were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.. Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).. Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF.. 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 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 HIV The purpose of this study is to expand our understanding of the metabolic effects of darunavir/ritonavir (DRV/r) in HIV-infected patients. --- M184V --- --- M184V ---



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