SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00358917

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 3, Randomized, Open-Label Study of Lopinavir/Ritonavir (LPV/r) Tablets 800/200 Milligram (mg) Once-Daily (QD) Versus 400/100 mg Twice-Daily (BID) When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in Antiretroviral-Experienced, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects

The purpose of this study was to compare the safety, tolerability, and antiviral activity of once-daily (QD) and twice-daily (BID) dosing of the lopinavir/ritonavir (LPV/r) tablet formulation in combination with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) in antiretroviral-experienced human immunodeficiency virus type 1 infected subjects with detectable viral load while receiving their current antiretroviral therapy.

NCT00358917 Human Immunodeficiency Virus Infections
MeSH: Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Virus Diseases
HPO: Immunodeficiency

2 Interventions

Name: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)

Description: LPV/r 800/200 mg once-daily (QD) tablet

Type: Drug

LPV/r 800/200 mg QD Tablet

Name: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)

Description: LPV/r 400/100 mg twice-daily (BID) tablet

Type: Drug

LPV/r 400/100 mg BID Tablet


Primary Outcomes

Description: A participant was classified as a responder at the first of 2 consecutive human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/mL. The participant continued to be a responder until 2 consecutive values >=50 copies/mL were reached, until the final value if that value was >=50 copies/mL, or until discontinuation or death.

Measure: Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm

Time: Week 48 (End of Study)

Secondary Outcomes

Measure: Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48

Time: Week 48 (End of Study)

Measure: Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts

Time: Week 48 (End of Study)

Description: Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.

Measure: Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir

Time: Week 48 (End of Study)

Description: Emergence of new primary protease inhibitor mutations (i.e., mutations at codons 30, 32, 48, 50, 82, 84, and 90 that were not present at baseline).

Measure: Percentage of Participants With New Primary Protease Mutations at Week 48

Time: Week 48 (End of Study)

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 10 SNPs

SNPs


1 G48V

Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir. Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.. Percentage of Participants With New Primary Protease Mutations at Week 48. --- L10F --- --- K20M --- --- L24I --- --- L33F --- --- M36I --- --- I47V --- --- G48V ---


2 I47V

Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir. Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.. Percentage of Participants With New Primary Protease Mutations at Week 48. --- L10F --- --- K20M --- --- L24I --- --- L33F --- --- M36I --- --- I47V ---


3 I54L

Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir. Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.. Percentage of Participants With New Primary Protease Mutations at Week 48. --- L10F --- --- K20M --- --- L24I --- --- L33F --- --- M36I --- --- I47V --- --- G48V --- --- I54L ---


4 I84V

Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir. Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.. Percentage of Participants With New Primary Protease Mutations at Week 48. --- L10F --- --- K20M --- --- L24I --- --- L33F --- --- M36I --- --- I47V --- --- G48V --- --- I54L --- --- V82A --- --- I84V ---


5 K20M

Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir. Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.. Percentage of Participants With New Primary Protease Mutations at Week 48. --- L10F --- --- K20M ---


6 L10F

Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir. Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.. Percentage of Participants With New Primary Protease Mutations at Week 48. --- L10F ---


7 L24I

Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir. Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.. Percentage of Participants With New Primary Protease Mutations at Week 48. --- L10F --- --- K20M --- --- L24I ---


8 L33F

Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir. Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.. Percentage of Participants With New Primary Protease Mutations at Week 48. --- L10F --- --- K20M --- --- L24I --- --- L33F ---


9 M36I

Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir. Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.. Percentage of Participants With New Primary Protease Mutations at Week 48. --- L10F --- --- K20M --- --- L24I --- --- L33F --- --- M36I ---


10 V82A

Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir. Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.. Percentage of Participants With New Primary Protease Mutations at Week 48. --- L10F --- --- K20M --- --- L24I --- --- L33F --- --- M36I --- --- I47V --- --- G48V --- --- I54L --- --- V82A ---



HPO Nodes


HPO:
Immunodeficiency
Genes 196
CYBB MYC MYD88 IL12B IRF2BP2 IL12RB1 RNF168 ACD ATRX AICDA TNFSF12 RTEL1 ACP5 CFTR NCF1 ACTB GATA1 CPLX1 GATA2 BLNK CDH23 FGFRL1 IKZF1 NCF2 CHD1 IRF7 SLC46A1 MAGT1 RREB1 PTEN ADA BCR ADA2 LYST ZBTB24 MEIS2 STAT1 PGM3 HIRA TNFRSF4 TYK2 STIM1 STK4 JAK3 MALT1 STX1A ICOS ANTXR2 PTPRC MBTPS2 TINF2 FCGR3A COG6 PIK3CA CARD9 CCDC47 NFE2L2 PIK3CD PIK3R1 AGL NFKB1 BTK NFKB2 UFD1 IL21 BUB1B PKP1 DKC1 AK2 UNG AKT1 NOP10 BCL10 UROS AP3D1 RAB27A SEC23B TBX1 SDHB SDHC RAC2 SDHD TBCE GP1BB DNMT3B CUL4B DOCK2 FOXN1 RAG1 RAG2 FRAS1 TCF3 CLCA4 LAMTOR2 WAS COMT WIPF1 USB1 CTC1 WHCR NSD2 FOS POLE SMARCAL1 AGPAT2 IRF8 IKBKG XIAP CHD7 SIN3A LMNB2 CAV1 SIK3 LCK PPARG XRCC4 WRAP53 FCN3 NHP2 SKIV2L CR2 TERC SP110 TERT JMJD1C SHANK3 LETM1 CRKL RBCK1 EPG5 TFRC TGFB1 TTC7A IFNGR1 IFNGR2 UNC119 RMRP USP8 ORAI1 LIG4 CORO1A CD3D CD3E KLLN CD3G CD247 BCL11B SEC24C LAT CD19 MS4A1 ISG15 ARVCF DCLRE1C CDCA7 MTHFD1 CD28 IGHM IL21R CD40 CD40LG IRAK4 TNFRSF13C LRRC8A TNFRSF13B PRKCD CD79A CD79B CD81 CTBP1 CARD11 PARN CAVIN1 BSCL2 CTLA4 IGLL1 PRKDC ATM MAPK1 LRBA DCTN4 TNFRSF1B CTPS1 IKBKB NHEJ1 HBB SH2D1A CDC42 IL2RA SPATA5 IL2RG MMUT IL7R HELLS CYBA PRPS1