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Report for Clinical Trial NCT00460746

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Open Label Phase 3b, 48 wk Pilot Study of the Antiviral Efficacy and Tolerability of Combination of PREZISTA/r and TMC125 When Substituted for Enfuvirtide, Current Protease Inhibitor(s) and NNRTI(s) in Antiretroviral Resistant Patients With Viral Suppression But Who Are Intolerant of Enfuvirtide.

The purpose of this study is to examine the safety, tolerability, and effectiveness of darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI(s)) and enfuvirtide are replaced by darunavir/ritonavir and TMC125 in HIV positive patients who can no longer tolerate enfuvirtide and are experiencing viral suppression. Other antiviral drugs in the regimen are to remain unchanged.

NCT00460746 HIV

1 Interventions

Name: TMC125, Darunavir; Ritonavir

Description: TMC125-200mg two times a day for 48 weeks; Darunavir -200mg two times a day for 48 weeks; Ritonavir-100mg two times a day for 48 weeks;
Type: Drug
Group Labels: 1

001


Primary Outcomes

Measure: Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.

Time: 48 weeks

Secondary Outcomes

Measure: Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.

Time: 48 weeks

Measure: CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.

Time: Week 48

Measure: CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.

Time: Week 48

Measure: Median Change From Baseline in Triglycerides at Week 48.

Time: Week 48

Measure: Median Change From Baseline in Total Cholesterol at Week 48.

Time: Week 48

Measure: Median Change From Baseline in LDL Cholesterol at Week 48.

Time: Week 48

Measure: Median Change From Baseline in HDL Cholesterol.

Time: Week 48

Measure: Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48.

Time: Week 48

Measure: Median Change From Baseline in Glucose at Week 48.

Time: Week 48

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There are 11 SNPs

SNPs


1 G73S

Exclusion Criteria: - No use of any drug contraindicated in the current US package insert for PREZISTA (darunavir) or in the investigators brochure for TMC125 - No prior or current therapy with PREZISTA (darunavir) or TMC125 - No prior genotypic results demonstrating 3 or more darunavir resistance-associated mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V or L89V). --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- I54M --- --- G73S ---


2 I47V

Exclusion Criteria: - No use of any drug contraindicated in the current US package insert for PREZISTA (darunavir) or in the investigators brochure for TMC125 - No prior or current therapy with PREZISTA (darunavir) or TMC125 - No prior genotypic results demonstrating 3 or more darunavir resistance-associated mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V or L89V). --- V11I --- --- V32I --- --- L33F --- --- I47V ---


3 I50V

Exclusion Criteria: - No use of any drug contraindicated in the current US package insert for PREZISTA (darunavir) or in the investigators brochure for TMC125 - No prior or current therapy with PREZISTA (darunavir) or TMC125 - No prior genotypic results demonstrating 3 or more darunavir resistance-associated mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V or L89V). --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V ---


4 I54L

Exclusion Criteria: - No use of any drug contraindicated in the current US package insert for PREZISTA (darunavir) or in the investigators brochure for TMC125 - No prior or current therapy with PREZISTA (darunavir) or TMC125 - No prior genotypic results demonstrating 3 or more darunavir resistance-associated mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V or L89V). --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L ---


5 I54M

Exclusion Criteria: - No use of any drug contraindicated in the current US package insert for PREZISTA (darunavir) or in the investigators brochure for TMC125 - No prior or current therapy with PREZISTA (darunavir) or TMC125 - No prior genotypic results demonstrating 3 or more darunavir resistance-associated mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V or L89V). --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- I54M ---


6 I84V

Exclusion Criteria: - No use of any drug contraindicated in the current US package insert for PREZISTA (darunavir) or in the investigators brochure for TMC125 - No prior or current therapy with PREZISTA (darunavir) or TMC125 - No prior genotypic results demonstrating 3 or more darunavir resistance-associated mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V or L89V). --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- I54M --- --- G73S --- --- L76V --- --- I84V ---


7 L33F

Exclusion Criteria: - No use of any drug contraindicated in the current US package insert for PREZISTA (darunavir) or in the investigators brochure for TMC125 - No prior or current therapy with PREZISTA (darunavir) or TMC125 - No prior genotypic results demonstrating 3 or more darunavir resistance-associated mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V or L89V). --- V11I --- --- V32I --- --- L33F ---


8 L76V

Exclusion Criteria: - No use of any drug contraindicated in the current US package insert for PREZISTA (darunavir) or in the investigators brochure for TMC125 - No prior or current therapy with PREZISTA (darunavir) or TMC125 - No prior genotypic results demonstrating 3 or more darunavir resistance-associated mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V or L89V). --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- I54M --- --- G73S --- --- L76V ---


9 L89V

Exclusion Criteria: - No use of any drug contraindicated in the current US package insert for PREZISTA (darunavir) or in the investigators brochure for TMC125 - No prior or current therapy with PREZISTA (darunavir) or TMC125 - No prior genotypic results demonstrating 3 or more darunavir resistance-associated mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V or L89V). --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- I54M --- --- G73S --- --- L76V --- --- I84V --- --- L89V ---


10 V11I

Exclusion Criteria: - No use of any drug contraindicated in the current US package insert for PREZISTA (darunavir) or in the investigators brochure for TMC125 - No prior or current therapy with PREZISTA (darunavir) or TMC125 - No prior genotypic results demonstrating 3 or more darunavir resistance-associated mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V or L89V). --- V11I ---


11 V32I

Exclusion Criteria: - No use of any drug contraindicated in the current US package insert for PREZISTA (darunavir) or in the investigators brochure for TMC125 - No prior or current therapy with PREZISTA (darunavir) or TMC125 - No prior genotypic results demonstrating 3 or more darunavir resistance-associated mutations associated with diminished response to darunavir (V11I, V32I, L33F, I47V, I50V, I54L, I54M, G73S, L76V, I84V or L89V). --- V11I --- --- V32I ---



HPO Nodes