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Report for Clinical Trial NCT00358917

Developed by Shray Alag, 2020.
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:Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes
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
Group Labels: 1

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
Group Labels: 1

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:
HP:0002721: Immunodeficiency
Genes 267
WHCR EPG5 CTPS1 MBTPS2 TLR3 IL2RG ISG15 CHD1 CLCA4 JAK3 PRKCD AK2 CD40LG FOXN1 NFE2L2 ATRX TNFRSF1B SKIV2L IFNGR1 TTC37 DCLRE1C TBCE BCR ZBTB24 CD3G BSCL2 SDHD XRCC4 LAMTOR2 IKZF1 AGPAT2 CTBP1 LRRC8A RAG2 ANTXR2 SLC46A1 CHD7 TINF2 CR2 IRF7 USP8 CD3E CD3D IL12B TNFRSF13C NHEJ1 IL2RG CD79B TNFSF12 EPG5 CUL4B ICOS LAT MAGT1 IL7R TBX1 TERT UNC93B1 LCK DCLRE1C MTHFD1 HIRA NSD2 CARD9 IRF8 UROS SHANK3 PIK3CD UFD1 NHP2 MYC CD81 CD79A TNFSF12 UNC119 RAG1 LRBA NCF2 LMNB2 BUB1B SEC23B FGFRL1 LYST CDCA7 BLNK RMRP FOS TCF3 RAG1 RBCK1 NFKB2 SIN3A CTLA4 JMJD1C CD81 MEIS2 PGM3 POLE IKBKG ADA IRF8 STAT1 PARN CFTR TNFRSF13C IL21R TNFRSF13B ICOS NFKB1 LIG4 CD28 SIK3 USB1 RAG1 IKBKG ADA DNMT3B RAG2 CR2 STX1A SEC24C SDHC ADA2 BTK IL2RG NCF1 FOXN1 TNFRSF13C LAMTOR2 ACTB SP110 RTEL1 SKIV2L PIK3R1 CDC42 RTEL1 CARD11 DNMT3B SDHB CDH23 HELLS PRKDC PIK3CA TYK2 AP3D1 TRAF3 FRAS1 CORO1A SPATA5 DOCK2 AKT1 RTEL1 XIAP FCGR3A TFRC ACD COMT ACP5 LETM1 RNF168 CD19 PNP POLE CHD1 RMRP AGL STAT1 ARVCF NFKB2 SH2D1A WAS NFKB1 IL21 AK2 IL2RA CDC42 GATA1 PARN ZBTB24 SMARCAL1 STIM1 TNFRSF13B NPM1 COG6 DKC1 CYBA MALT1 MS4A1 ICOS PTEN DCTN4 TINF2 DKC1 LIG4 TBX1 CR2 PRPS1 RAG1 UNG CAV1 HYOU1 RAC2 LYST IRAK4 RAB27A TNFRSF4 TGFB1 FCN3 USF3 HBB CCDC47 IFNGR2 RREB1 IRAK4 IKBKG CD19 CAVIN1 RAG2 PPARG AICDA IKBKB CD40 PGM3 PKP1 KLLN MYD88 CPLX1 EXTL3 MMUT XIAP STAT1 ORAI1 IKBKG CD19 CD247 TBK1 CYBB PIK3R1 TICAM1 CTC1 WRAP53 GP1BB TTC7A TTC7A NOP10 RNF168 BCL10 MAPK1 WIPF1 MS4A1 IL12RB1 TERC DKC1 BCL11B XRCC4 IGHM STK4 IL7R PTPRC IGLL1 CRKL IL2RB ATM IRF2BP2 GATA2 SPATA5 TERT
SNP 0