SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00337467

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Phase IIIb Multicenter, Single Arm, Open-Label Pilot Study to Evaluate the Effectiveness and Safety of Maintenance With Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in HIV-Infected Patients Evidencing Virologic Suppression OREY (Only REYataz) Study

The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure.

NCT00337467 Human Immunodeficiency Virus (HIV) Infections
MeSH: Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections
HPO: Immunodeficiency

1 Interventions

Name: Atazanavir + Ritonavir

Description: Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks

Type: Drug

A1


Primary Outcomes

Description: Treatment Failure through Week 48 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy.

Measure: Percentage of Participants With Treatment Failure Through Week 48

Time: Week 48

Secondary Outcomes

Description: Treatment Failure through Week 96 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 96 or study discontinuation before Week 96. In addition, treatment failure defined based on HIV RNA >= 50 c/mL, latter analysis performed on treated subjects with baseline HIV RNA < 50 c/mL.

Measure: Percentage of Participants With Treatment Failure Through Week 96

Time: Week 96

Description: Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL.

Measure: Percentage of Participants With Virological Rebound Through Week 48

Time: Week 48

Description: Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL.

Measure: Percentage of Participants With Virological Rebound Through Week 96

Time: Week 96

Description: This Kaplan-Meier life table reports the cumulative proportion of participants without treatment failure up to the end of the respective time interval. Failure time is measured from the start of study therapy, and is based on the earliest event defining failure (virologic rebound at or before Week 96, or discontinuation prior to Week 96).

Measure: Cumulative Proportion of Participants Without Treatment Failure Through Week 100

Time: Through Week 100

Description: Virologic rebound is defined as confirmed on-study HIV RNA ≥ 400 c/mL or last on-study HIV RNA ≥ 400 c/mL followed by treatment discontinuation.

Measure: Proportion of Participants With Virologic Rebound Through Week 96

Time: Through Week 96

Measure: Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24

Time: Baseline, Week 24

Measure: Mean Change From Baseline in CD4 Cell Count at Week 48

Time: Baseline, Week 48

Measure: Mean Change From Baseline in CD4 Cell Count at Week 96

Time: Baseline, Week 96

Description: AE=any new untoward medical occurrence or worsening of a pre-existing medical condition that does not necessarily have a causal relationship to treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. AE grades are: mild (1), moderate (2), severe (3), life-threatening (4), and death (5).

Measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs

Time: From Baseline through Week 96

Description: Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.

Measure: Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48

Time: Baseline, Week 48

Description: Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.

Measure: Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96

Time: Baseline, Week 96

Description: International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.

Measure: Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48

Time: Week 48

Description: International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.

Measure: Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96

Time: Week 96

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There are 13 SNPs

SNPs


1 G48V

International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. --- V32I --- --- L33F --- --- M46I --- --- I47V --- --- G48V ---


2 I47V

International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. --- V32I --- --- L33F --- --- M46I --- --- I47V ---


3 I50L

International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. --- V32I --- --- L33F --- --- M46I --- --- I47V --- --- G48V --- --- I50L ---


4 I54M

International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. --- V32I --- --- L33F --- --- M46I --- --- I47V --- --- G48V --- --- I50L --- --- I54M ---


5 I76V

International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. --- V32I --- --- L33F --- --- M46I --- --- I47V --- --- G48V --- --- I50L --- --- I54M --- --- I76V ---


6 I82A

International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. --- V32I --- --- L33F --- --- M46I --- --- I47V --- --- G48V --- --- I50L --- --- I54M --- --- I76V --- --- I82A ---


7 I84V

International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. --- V32I --- --- L33F --- --- M46I --- --- I47V --- --- G48V --- --- I50L --- --- I54M --- --- I76V --- --- I82A --- --- I84V ---


8 L33F

International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. --- V32I --- --- L33F ---


9 L90M

International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. --- V32I --- --- L33F --- --- M46I --- --- I47V --- --- G48V --- --- I50L --- --- I54M --- --- I76V --- --- I82A --- --- I84V --- --- N88S --- --- L90M ---


10 M184V

Reverse Transcriptase (RT) are TAMS and M184V.. Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96. --- M184V ---

Reverse Transcriptase (RT) are TAMS and M184V.. Inclusion Criteria: - On continued antiretroviral (ARV) treatment, with no discontinuation periods, for the previous 6 months (24 weeks). --- M184V ---


11 M46I

International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. --- V32I --- --- L33F --- --- M46I ---


12 N88S

International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. --- V32I --- --- L33F --- --- M46I --- --- I47V --- --- G48V --- --- I50L --- --- I54M --- --- I76V --- --- I82A --- --- I84V --- --- N88S ---


13 V32I

International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. --- V32I ---



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