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Report for Clinical Trial NCT00337467

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

1 Interventions

Name: Atazanavir + Ritonavir

Description: Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks
Type: Drug
Group Labels: 1

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:
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