SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00650832

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase II Randomized, Controlled, Partially Blinded Trial to Investigate Dose-response of TMC114/RTV in 3-class-experienced HIV-1 Infected Subjects, Followed by an Open-label Period on the Recommended Dose of TMC114/RTV.

The purpose of this study is to determine the antiviral activity, safety and tolerability of TMC114, formulated as an oral tablet, and administered with a low dose of ritonavir

NCT00650832 HIV

1 Interventions

Name: TMC114; darunavir; Prezista

Type: Drug


Primary Outcomes

Measure: The primary objective of the trial is to compare all TMC114/RTV dose groups with control at Week 24 (the primary endpoint) by means of the confirmed virologic response, defined as a drop in viral load of at least 1 log10 versus baseline.

Secondary Outcomes

Measure: To evaluate safety and tolerability over 24 to 144 weeks; To evaluate the durability of the antiviral activity; To investigate the dose-response by comparing the different TMC114/RTV dosages.

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 7 SNPs

SNPs


1 D30N

Inclusion Criteria: - Patients with documented HIV-1 infection - Patients receiving a PI-containing regimen at screening initiated at least 8 weeks prior to screening with plasma HIV-1 RNA > 1000 copies/mL - Prior use of more than 1 NRTI for at least 3 months in total - Prior use of one or more NNRTIs (investigational included) as part of a failing regimen - Patients having at least 1 primary PI mutation at screening as defined by the IAS guidelines (D30N, M46I/L, G48V, I50V/L, V82A/F/T/S, I84V, L90M)16 - patients experienced to at least one PI for a total period of at least 3 months - Patients voluntarily signs the informed consent form - Patients can comply with the protocol requirements - Patients having a general medical condition that, in the investigator's opinion, does not interfere with the assessments and the completion of the trial. --- D30N ---


2 G48V

Inclusion Criteria: - Patients with documented HIV-1 infection - Patients receiving a PI-containing regimen at screening initiated at least 8 weeks prior to screening with plasma HIV-1 RNA > 1000 copies/mL - Prior use of more than 1 NRTI for at least 3 months in total - Prior use of one or more NNRTIs (investigational included) as part of a failing regimen - Patients having at least 1 primary PI mutation at screening as defined by the IAS guidelines (D30N, M46I/L, G48V, I50V/L, V82A/F/T/S, I84V, L90M)16 - patients experienced to at least one PI for a total period of at least 3 months - Patients voluntarily signs the informed consent form - Patients can comply with the protocol requirements - Patients having a general medical condition that, in the investigator's opinion, does not interfere with the assessments and the completion of the trial. --- D30N --- --- M46I --- --- G48V ---


3 I50V

Inclusion Criteria: - Patients with documented HIV-1 infection - Patients receiving a PI-containing regimen at screening initiated at least 8 weeks prior to screening with plasma HIV-1 RNA > 1000 copies/mL - Prior use of more than 1 NRTI for at least 3 months in total - Prior use of one or more NNRTIs (investigational included) as part of a failing regimen - Patients having at least 1 primary PI mutation at screening as defined by the IAS guidelines (D30N, M46I/L, G48V, I50V/L, V82A/F/T/S, I84V, L90M)16 - patients experienced to at least one PI for a total period of at least 3 months - Patients voluntarily signs the informed consent form - Patients can comply with the protocol requirements - Patients having a general medical condition that, in the investigator's opinion, does not interfere with the assessments and the completion of the trial. --- D30N --- --- M46I --- --- G48V --- --- I50V ---


4 I84V

Inclusion Criteria: - Patients with documented HIV-1 infection - Patients receiving a PI-containing regimen at screening initiated at least 8 weeks prior to screening with plasma HIV-1 RNA > 1000 copies/mL - Prior use of more than 1 NRTI for at least 3 months in total - Prior use of one or more NNRTIs (investigational included) as part of a failing regimen - Patients having at least 1 primary PI mutation at screening as defined by the IAS guidelines (D30N, M46I/L, G48V, I50V/L, V82A/F/T/S, I84V, L90M)16 - patients experienced to at least one PI for a total period of at least 3 months - Patients voluntarily signs the informed consent form - Patients can comply with the protocol requirements - Patients having a general medical condition that, in the investigator's opinion, does not interfere with the assessments and the completion of the trial. --- D30N --- --- M46I --- --- G48V --- --- I50V --- --- V82A --- --- I84V ---


5 L90M

Inclusion Criteria: - Patients with documented HIV-1 infection - Patients receiving a PI-containing regimen at screening initiated at least 8 weeks prior to screening with plasma HIV-1 RNA > 1000 copies/mL - Prior use of more than 1 NRTI for at least 3 months in total - Prior use of one or more NNRTIs (investigational included) as part of a failing regimen - Patients having at least 1 primary PI mutation at screening as defined by the IAS guidelines (D30N, M46I/L, G48V, I50V/L, V82A/F/T/S, I84V, L90M)16 - patients experienced to at least one PI for a total period of at least 3 months - Patients voluntarily signs the informed consent form - Patients can comply with the protocol requirements - Patients having a general medical condition that, in the investigator's opinion, does not interfere with the assessments and the completion of the trial. --- D30N --- --- M46I --- --- G48V --- --- I50V --- --- V82A --- --- I84V --- --- L90M ---


6 M46I

Inclusion Criteria: - Patients with documented HIV-1 infection - Patients receiving a PI-containing regimen at screening initiated at least 8 weeks prior to screening with plasma HIV-1 RNA > 1000 copies/mL - Prior use of more than 1 NRTI for at least 3 months in total - Prior use of one or more NNRTIs (investigational included) as part of a failing regimen - Patients having at least 1 primary PI mutation at screening as defined by the IAS guidelines (D30N, M46I/L, G48V, I50V/L, V82A/F/T/S, I84V, L90M)16 - patients experienced to at least one PI for a total period of at least 3 months - Patients voluntarily signs the informed consent form - Patients can comply with the protocol requirements - Patients having a general medical condition that, in the investigator's opinion, does not interfere with the assessments and the completion of the trial. --- D30N --- --- M46I ---


7 V82A

Inclusion Criteria: - Patients with documented HIV-1 infection - Patients receiving a PI-containing regimen at screening initiated at least 8 weeks prior to screening with plasma HIV-1 RNA > 1000 copies/mL - Prior use of more than 1 NRTI for at least 3 months in total - Prior use of one or more NNRTIs (investigational included) as part of a failing regimen - Patients having at least 1 primary PI mutation at screening as defined by the IAS guidelines (D30N, M46I/L, G48V, I50V/L, V82A/F/T/S, I84V, L90M)16 - patients experienced to at least one PI for a total period of at least 3 months - Patients voluntarily signs the informed consent form - Patients can comply with the protocol requirements - Patients having a general medical condition that, in the investigator's opinion, does not interfere with the assessments and the completion of the trial. --- D30N --- --- M46I --- --- G48V --- --- I50V --- --- V82A ---



HPO Nodes