SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00122590

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Prospective Trial to Evaluate How Therapeutic Drug Monitoring of Protease Inhibitors Increases Virologic Success and Tolerance of HAART (ANRS 111 COPHAR2)

This Cophar2 study is a trial which evaluates repeated early therapeutic drug monitoring, from weeks 2 to 24, after the initiation of HAART including either indinavir/r, lopinavir/r or the new 625 mg formulation of nelfinavir twice-a-day (bid). If trough concentrations were out of the range given for each protease inhibitor (PI), the PI dose was adjusted.

NCT00122590 HIV Infections
MeSH: HIV Infections

4 Interventions

Name: nelfinavir

Type: Drug

Name: lopinavir/r

Type: Drug

Name: indinavir

Type: Drug

Name: ritonavir

Type: Drug


Primary Outcomes

Measure: treatment failure defined as viral load greater than 200 copies/ml between week 16 (W16) and week 48 (W48) (confirmed by 2 samples spiked at least 15 days apart but no more than 45 days after virological failure, assayed by 50 copies/ml method)

Measure: toxicity related to PI, defined as adverse event grade 3 or 4 with ANRS quotation, renal colic, diarrhoea grade 2, or cholesterolemia over 10 times the normal value

Secondary Outcomes

Measure: virological failure: viral load over 200 copies/ml between W16 and W48 (confirmed by 2 samples spiked at least 15 days apart but no more than 45 days after virological failure, assayed by 50 copies/ml method)

Measure: toxicity related to PI: adverse events grade 3 or 4 with ANRS quotation, renal colic, diarrhoea grade 2, or cholesterolemia over 10 times the normal value

Measure: patients with trough plasma concentrations outside the therapeutic range at W24 and W48

Measure: concentration changes with dosage variation

Measure: time to obtain a viral load below 200 copies/ml

Measure: relationship between adverse events grade 3 or 4 related to PI and plasma concentration at week 2 (W2)

Measure: relationship between pharmacokinetic parameters and/or plasma concentrations and the drop of viral load between day 0 (D0) and W2 and between D0 and week 4 (W4)

Measure: relationship between pharmacokinetic parameters and viral mutations occurring during the treatment of patients with virological failure (over 1000 copies/ml after week 24 [W24])

Measure: PI pharmacokinetic parameter estimation and evaluation of variability

Measure: pharmacokinetic variability of nucleoside analogues at W2

Measure: intracellular concentration of nucleoside triphosphate derivatives at W2 (trough and maximum) and relationship between virological response and adverse events

Measure: relationship between inhibitory quotient of indinavir and virological response

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There are 5 SNPs

SNPs


1 L74V

Inclusion Criteria: - Patients infected with HIV-1 - Needing an antiretroviral treatment according to standard of care - HIV viral load greater than 1000 copies/ml - Beginning a treatment containing a PI (indinavir with or without ritonavir, nelfinavir, lopinavir + ritonavir) and 2 reverse transcriptase inhibitors - PI-naive - Antiretroviral treatment-naive or already treated with reverse transcriptase inhibitors but if the viral genotypic test does not show more than 2 major mutations (including T215Y/F, Q151M, M184V/I, V75M/S, L74V) and if 3 nucleoside analogues are still active except for didanosine. --- T215Y --- --- Q151M --- --- M184V --- --- V75M --- --- L74V ---

Exclusion Criteria: - Pregnant women and nursing mothers - Acute HIV infection - Diabetes - Renal insufficiency with creatinine clearance below 30 ml/min - Cardiac insufficiency - Hepatic insufficiency with TP below 60% - Treatment with known interactions with PI - Chemotherapy against Kaposi's sarcoma, lymphoma, neoplasia - Treatment containing interferon (INF) or interleukin-2 (IL2) or HIV- immune vaccine - Treatment with hypolipemic drugs - Laxative treatment - Previous renal colic - Diarrhoea with more than 5 stools/day since one week Inclusion Criteria: - Patients infected with HIV-1 - Needing an antiretroviral treatment according to standard of care - HIV viral load greater than 1000 copies/ml - Beginning a treatment containing a PI (indinavir with or without ritonavir, nelfinavir, lopinavir + ritonavir) and 2 reverse transcriptase inhibitors - PI-naive - Antiretroviral treatment-naive or already treated with reverse transcriptase inhibitors but if the viral genotypic test does not show more than 2 major mutations (including T215Y/F, Q151M, M184V/I, V75M/S, L74V) and if 3 nucleoside analogues are still active except for didanosine. --- T215Y --- --- Q151M --- --- M184V --- --- V75M --- --- L74V ---


2 M184V

Inclusion Criteria: - Patients infected with HIV-1 - Needing an antiretroviral treatment according to standard of care - HIV viral load greater than 1000 copies/ml - Beginning a treatment containing a PI (indinavir with or without ritonavir, nelfinavir, lopinavir + ritonavir) and 2 reverse transcriptase inhibitors - PI-naive - Antiretroviral treatment-naive or already treated with reverse transcriptase inhibitors but if the viral genotypic test does not show more than 2 major mutations (including T215Y/F, Q151M, M184V/I, V75M/S, L74V) and if 3 nucleoside analogues are still active except for didanosine. --- T215Y --- --- Q151M --- --- M184V ---

Exclusion Criteria: - Pregnant women and nursing mothers - Acute HIV infection - Diabetes - Renal insufficiency with creatinine clearance below 30 ml/min - Cardiac insufficiency - Hepatic insufficiency with TP below 60% - Treatment with known interactions with PI - Chemotherapy against Kaposi's sarcoma, lymphoma, neoplasia - Treatment containing interferon (INF) or interleukin-2 (IL2) or HIV- immune vaccine - Treatment with hypolipemic drugs - Laxative treatment - Previous renal colic - Diarrhoea with more than 5 stools/day since one week Inclusion Criteria: - Patients infected with HIV-1 - Needing an antiretroviral treatment according to standard of care - HIV viral load greater than 1000 copies/ml - Beginning a treatment containing a PI (indinavir with or without ritonavir, nelfinavir, lopinavir + ritonavir) and 2 reverse transcriptase inhibitors - PI-naive - Antiretroviral treatment-naive or already treated with reverse transcriptase inhibitors but if the viral genotypic test does not show more than 2 major mutations (including T215Y/F, Q151M, M184V/I, V75M/S, L74V) and if 3 nucleoside analogues are still active except for didanosine. --- T215Y --- --- Q151M --- --- M184V ---


3 Q151M

Inclusion Criteria: - Patients infected with HIV-1 - Needing an antiretroviral treatment according to standard of care - HIV viral load greater than 1000 copies/ml - Beginning a treatment containing a PI (indinavir with or without ritonavir, nelfinavir, lopinavir + ritonavir) and 2 reverse transcriptase inhibitors - PI-naive - Antiretroviral treatment-naive or already treated with reverse transcriptase inhibitors but if the viral genotypic test does not show more than 2 major mutations (including T215Y/F, Q151M, M184V/I, V75M/S, L74V) and if 3 nucleoside analogues are still active except for didanosine. --- T215Y --- --- Q151M ---

Exclusion Criteria: - Pregnant women and nursing mothers - Acute HIV infection - Diabetes - Renal insufficiency with creatinine clearance below 30 ml/min - Cardiac insufficiency - Hepatic insufficiency with TP below 60% - Treatment with known interactions with PI - Chemotherapy against Kaposi's sarcoma, lymphoma, neoplasia - Treatment containing interferon (INF) or interleukin-2 (IL2) or HIV- immune vaccine - Treatment with hypolipemic drugs - Laxative treatment - Previous renal colic - Diarrhoea with more than 5 stools/day since one week Inclusion Criteria: - Patients infected with HIV-1 - Needing an antiretroviral treatment according to standard of care - HIV viral load greater than 1000 copies/ml - Beginning a treatment containing a PI (indinavir with or without ritonavir, nelfinavir, lopinavir + ritonavir) and 2 reverse transcriptase inhibitors - PI-naive - Antiretroviral treatment-naive or already treated with reverse transcriptase inhibitors but if the viral genotypic test does not show more than 2 major mutations (including T215Y/F, Q151M, M184V/I, V75M/S, L74V) and if 3 nucleoside analogues are still active except for didanosine. --- T215Y --- --- Q151M ---


4 T215Y

Inclusion Criteria: - Patients infected with HIV-1 - Needing an antiretroviral treatment according to standard of care - HIV viral load greater than 1000 copies/ml - Beginning a treatment containing a PI (indinavir with or without ritonavir, nelfinavir, lopinavir + ritonavir) and 2 reverse transcriptase inhibitors - PI-naive - Antiretroviral treatment-naive or already treated with reverse transcriptase inhibitors but if the viral genotypic test does not show more than 2 major mutations (including T215Y/F, Q151M, M184V/I, V75M/S, L74V) and if 3 nucleoside analogues are still active except for didanosine. --- T215Y ---

Exclusion Criteria: - Pregnant women and nursing mothers - Acute HIV infection - Diabetes - Renal insufficiency with creatinine clearance below 30 ml/min - Cardiac insufficiency - Hepatic insufficiency with TP below 60% - Treatment with known interactions with PI - Chemotherapy against Kaposi's sarcoma, lymphoma, neoplasia - Treatment containing interferon (INF) or interleukin-2 (IL2) or HIV- immune vaccine - Treatment with hypolipemic drugs - Laxative treatment - Previous renal colic - Diarrhoea with more than 5 stools/day since one week Inclusion Criteria: - Patients infected with HIV-1 - Needing an antiretroviral treatment according to standard of care - HIV viral load greater than 1000 copies/ml - Beginning a treatment containing a PI (indinavir with or without ritonavir, nelfinavir, lopinavir + ritonavir) and 2 reverse transcriptase inhibitors - PI-naive - Antiretroviral treatment-naive or already treated with reverse transcriptase inhibitors but if the viral genotypic test does not show more than 2 major mutations (including T215Y/F, Q151M, M184V/I, V75M/S, L74V) and if 3 nucleoside analogues are still active except for didanosine. --- T215Y ---


5 V75M

Inclusion Criteria: - Patients infected with HIV-1 - Needing an antiretroviral treatment according to standard of care - HIV viral load greater than 1000 copies/ml - Beginning a treatment containing a PI (indinavir with or without ritonavir, nelfinavir, lopinavir + ritonavir) and 2 reverse transcriptase inhibitors - PI-naive - Antiretroviral treatment-naive or already treated with reverse transcriptase inhibitors but if the viral genotypic test does not show more than 2 major mutations (including T215Y/F, Q151M, M184V/I, V75M/S, L74V) and if 3 nucleoside analogues are still active except for didanosine. --- T215Y --- --- Q151M --- --- M184V --- --- V75M ---

Exclusion Criteria: - Pregnant women and nursing mothers - Acute HIV infection - Diabetes - Renal insufficiency with creatinine clearance below 30 ml/min - Cardiac insufficiency - Hepatic insufficiency with TP below 60% - Treatment with known interactions with PI - Chemotherapy against Kaposi's sarcoma, lymphoma, neoplasia - Treatment containing interferon (INF) or interleukin-2 (IL2) or HIV- immune vaccine - Treatment with hypolipemic drugs - Laxative treatment - Previous renal colic - Diarrhoea with more than 5 stools/day since one week Inclusion Criteria: - Patients infected with HIV-1 - Needing an antiretroviral treatment according to standard of care - HIV viral load greater than 1000 copies/ml - Beginning a treatment containing a PI (indinavir with or without ritonavir, nelfinavir, lopinavir + ritonavir) and 2 reverse transcriptase inhibitors - PI-naive - Antiretroviral treatment-naive or already treated with reverse transcriptase inhibitors but if the viral genotypic test does not show more than 2 major mutations (including T215Y/F, Q151M, M184V/I, V75M/S, L74V) and if 3 nucleoside analogues are still active except for didanosine. --- T215Y --- --- Q151M --- --- M184V --- --- V75M ---



HPO Nodes