SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation N88S

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 5 clinical trials

Clinical Trials


1 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
Conditions
  1. Human Immunodeficiency Virus (HIV) Infections
Interventions
  1. Drug: Atazanavir + Ritonavir
MeSH:Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency S Immunologic Deficiency Syndromes
HPO:Immunodeficiency

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 ---

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

2 Prospective Clinical Trial to Assess Safety and Efficacy of DRV/r(TMC 114/r), ETV(TMC 125) and MK-0518 in Addition to OBT in HIV-1 Infected Patients With Limited to No Treatment Options ANRS 139 TRIO

The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.

NCT00460382
Conditions
  1. HIV Infections
Interventions
  1. Drug: raltegravir potassium
  2. Drug: darunavir/ritonavir
  3. Drug: etravirine
  4. Drug: Optimized background regimen
MeSH:HIV Infections

- Genotypic resistance testing at the screening visit: - Protease inhibitor mutations: over or equal to 3 primary protease inhibitor mutations among: D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, I54M, L76V, V82A/F/L/T/S, I84V, N88S and L90M (IAS list 2006) but below or equal to 3 mutations among the following: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, L76V, I84V et L89V (virus sensitivity to darunavir/ritonavir). - Reverse transcriptase mutations: over or equal to 3 NRTI mutations (among IAS list) and below or equal to 3 mutations among: A98G, L100I, K101Q/P/E, K103H/N/S/T, V106A/M, V108I, E138G/K/Q, V179D/E/F/G/I, Y181C/I/V/C/H/L, Y188C/H/L, G190A/C/E/Q/S, P225H, F227C/L, M230I/L, P236L, K238N/T and Y318F (virus sensitivity to etravirine) Exclusion Criteria: - Non effective barrier contraception in women of child bearing potential - Pregnant women or women who are breastfeeding - Opportunistic infection at the acute phase - Decompensated cirrhosis (stage B or C of Child-Pugh score) - Malignancy requiring chemotherapy or radiotherapy - Contraindicated medications being taken by the patient (listed in protocol) - Allergy to the active substances and expedients of darunavir, etravirine and raltegravir. --- D30N --- --- V32I --- --- L33F --- --- M46I --- --- I47A --- --- G48V --- --- I50L --- --- I54M --- --- L76V --- --- V82A --- --- I84V --- --- N88S ---

Primary Outcomes

Measure: Proportion of patients with HIV RNA levels of less than 50 copies/ml in an intent to treat analysis at week 24

Time: week 24

Secondary Outcomes

Measure: Proportions of patients with HIV RNA levels of less than 50 copies/ml at week 48, with HIV RNA levels of less than 400 copies/ml at weeks 24 and 48

Time: week 24 and 48

Measure: HIV RNA level evolution between baseline and week 48

Time: from week 0 to 48

Measure: HIV proviral DNA and 2LTR circle HIV DNA between baseline and week 48

Time: from week 0 to 48

Measure: Number and type of resistance mutations in case of virologic failure occurrence

Time: from week 0 to 48

Measure: CD4 lymphocyte count and proportion evolution between baseline and week 48

Time: from week 0 to 48

Measure: HIV infection progression

Time: from week 0 to 48

Measure: Frequency of the study regimen modifications and interruption

Time: from week 0 to 48

Measure: Study regimen tolerance

Time: from week 0 to 48

Measure: Study regimen adherence

Time: from week 0 to 48

Measure: Association between study drugs' minimum concentrations at week 4 and week 12 and virologic success at week 24

Time: from week 4 to 24

Measure: Evolution of pharmacokinetics parameters of study drugs in the PK substudy

Time: betwwen week 1 and 4

3 Phase 2 Dose-escalating, P-C, D-B, Parallel Group Study in HIV Treatment-experienced Patients to Evaluate the Safety, Tolerability and Efficacy of PA103001-04 Administered as Functional Monotherapy for 14 Days *(PART B)

The purpose of this study is to evaluate antiretroviral activity of up to five different oral doses administered for two weeks of bevirimat versus placebo in HIV treatment experienced patients, who have documented genotypic resistance to at least one major mutation from the IAS-USA list (2007)of resistance mutations for NRTIs, NNRTIs, or PIs. Patients will also be monitored for side effects, and the pharmacokinetics of bevirimat will be determined.

NCT00511368
Conditions
  1. HIV Infections
Interventions
  1. Drug: matching placebo
  2. Drug: Bevirimat
MeSH:HIV Infections

- Have documented evidence of genotypic resistance in their medical records (at screening) or have resistance at screening by genotype to any major mutation from the IAS-USA list of resistance drug mutations, defined as: NRTI resistance: M41L, K65R, D67N, K70R, K70E, L74V, Y115F, M184V, M184V/I, L210W, T215Y/F, K219Q/E; NNRTI resistance: L100I, K103N, V106M, V106A/M, V108I, Y181C, Y181C/I, Y188L, Y188C/L/H, G190S/A, G190A, P225H; Major PI resistance: D30N, V32I, L33F, M46I/L, I47V/A, G48V, I50L, I50V, I54M/L, L76V, V82A/F/T, V82A/F/T/S, V82L/T, I84V, N88S, L90M - Be receiving an antiretroviral therapy regimen containing at least 3 drugs (regimens containing ritonavir must not exceed a total daily dose of 400 mg) which has been unchanged for at least 8 weeks prior to initial screening. --- M41L --- --- K65R --- --- D67N --- --- K70R --- --- K70E --- --- L74V --- --- Y115F --- --- M184V --- --- M184V --- --- L210W --- --- T215Y --- --- K219Q --- --- L100I --- --- K103N --- --- V106M --- --- V106A --- --- V108I --- --- Y181C --- --- Y181C --- --- Y188L --- --- Y188C --- --- G190S --- --- G190A --- --- P225H --- --- D30N --- --- V32I --- --- L33F --- --- M46I --- --- I47V --- --- G48V --- --- I50L --- --- I50V --- --- I54M --- --- L76V --- --- V82A --- --- V82A --- --- V82L --- --- I84V --- --- N88S ---

Primary Outcomes

Measure: HIV-1 RNA change from baseline over the first 14 days of study

Time: 14 days

Secondary Outcomes

Measure: safety and tolerability; pharmacokinetics

Time: 14 days

4 A Phase II, Randomized Trial of Open-Label Truvada With Darunavir/Ritonavir Versus Multiclass Therapy With Truvada, Darunavir/Ritonavir, Maraviroc and Raltegravir in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects

The researchers are involved in a phase II, randomized, two-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women. Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the investigator and patient that continued therapy is in the patient's best interest. Hypotheses: - Multi-class antiretroviral therapy (ART) is superior to RTV-enhanced ATV in combination with Emtricitabine/Tenofovir DF (FTC/TDF) with respect to suppression of viral replication. - Multi-class ART is superior to RTV-enhanced ATV in combination with FTC/TDF with respect to immune reconstitution in peripheral blood and in the gastrointestinal mucosa. - Multi-class ART is equivalent to RTV-enhanced ATV in combination with FTC/TDF with respect to tolerability.

NCT00525733
Conditions
  1. HIV Infections
Interventions
  1. Drug: darunavir 800 mg
  2. Drug: FTC 200 mg/TDF 300mg
  3. Drug: Maraviroc
  4. Drug: Raltegravir
  5. Drug: Ritonavir 100 mg
MeSH:Infection HIV Infections

Major resistance-associated mutations include: NRTI: K65R or inserts Q151M, M184V/I, PI: I50L/V, I84V, N88S. --- K65R --- --- Q151M --- --- M184V --- --- I50L --- --- I84V --- --- N88S ---

Primary Outcomes

Measure: The Primary Outcome of This Study is the Proportion of Patients Having Detectable HIV-1 RNA Using the Single Copy Assay After 48 Weeks of Treatment and the Study Hypothesis is That New Treatment is Better Than the Control Group.

Time: 48 weeks

5 An Open-Label Phase 3B Study in HIV-Infected Individuals With Viremia on or After Their First-Line Non-Nucleoside Reverse Transcriptase Inhibitor or Integrase Inhibitor-Based Regimen and Starting a Second-Line Regimen Consisting of ATV/RTV or DRV/RTV With an Optimized NRTI Backbone

The purpose of this study is to determine the proportion of subjects with HIV-1 RNA < 50 c/mL at Week 48 in patients who failed their first line therapy containing a non-nucleoside reverse transcriptase inhibitor (NNRTI) or an integrase inhibitor

NCT01605084
Conditions
  1. HIV
Interventions
  1. Drug: Atazanavir
  2. Drug: Darunavir
  3. Drug: Ritonavir
  4. Drug: Optimized NRTI backbone

An NRTI or PI (reported with or without ritonavir) with a "partially sensitive" net assessment will not be considered "fully sensitive" 4. Mentally able to participate in the study 5. Men and women ≥ 18 years old - Women of child bearing potential who engage in vaginal intercourse and who are not clinically sterilized must use highly effective methods of birth control during the study Exclusion Criteria: 1. Screening HIV genotype showing presence at baseline of any of the following Protease inhibitor (PI) Mutation Patterns associated with genotypic resistance to Atazanavir sulfate/ Ritonavir or Darunavir/Ritonavir will lead to exclusion: 1. Subjects with any darunavir associated mutations* at baseline (*V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V) 2. Subjects with a major mutation to Atazanavir sulfate consisting of N88S 3. Subjects with more than 3 of any of the following Atazanavir sulfate related mutations:D30N, M36I/V, M46I/L/T, I54V/L/T/M/A, A71V/T/I/G, G73S/A/C/T, V77I, V82A/F/T/S/I, I84V/A, N88D or L90M 2. Subjects with < 1 fully active NRTI on PhenoSense report, other than lamivudine and emtricitabine 3. Diagnosed with active tuberculosis 4. Chronic hepatitis B infection 5. Hepatitis C-positive patients who are not clinically stable or need treatment during the study period 6. --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- I54M --- --- T74P --- --- L76V --- --- I84V --- --- L89V --- --- N88S ---

Primary Outcomes

Measure: Proportion of subjects with Human immunodeficiency virus 1 (HIV-1) Ribonucleic Acid (RNA) < 50 c/mL

Time: At Week 48

Secondary Outcomes

Measure: Proportion of subjects with HIV-1 RNA < 50 c/mL

Time: At week 24

Measure: Change from baseline in CD4 cell count

Time: Baseline (Week 0) and at week 48

Measure: Incidence rates of serious adverse event (SAEs) and adverse events (AEs) leading to discontinuation

Time: up to week 48

Measure: Incidence rates of antiretroviral resistance measured by newly emergent genotypic substitutions and phenotypic resistance to study drugs for virologic failure

Time: up to week 48

Measure: Proportion of subjects with HIV-1 RNA < 50 c/mL at Week 48 by baseline M184V presence or absence

Time: Week 48


HPO Nodes


HP:0002721: Immunodeficiency
Genes 270
DCLRE1C DKC1 NHEJ1 CDC42 AK2 DNAJC21 CD81 CD3E PGM3 CDC42 CD3G FOXN1 NFKB2 ANTXR2 SIK3 BCL10 TNFRSF13C STAT1 LIG4 ZBTB24 GP1BB USP8 IRAK4 IL2RG DNMT3B IFNGR1 SEC24C CHD7 CPLX1 RREB1 TNFRSF13C ZBTB24 LYST ARVCF STK4 RNF168 CYBB NFKB1 TINF2 TBX1 NSD2 IKZF1 LRBA IRF8 XRCC4 ACTB TYK2 HELLS FCN3 CDH23 CD28 MAN2B1 ATM WHCR MMUT ISG15 CR2 FCGR3A JMJD1C CD247 UFD1 IKBKB CTPS1 CREBBP UNG CTLA4 ICOS RAG1 CDCA7 BCL11B RMRP PRKCD GATA2 SPATA5 TICAM1 IL21R POLE CLCA4 STX1A RAG2 MALT1 TNFRSF4 RAB27A IRAK4 LRRC8A SHANK3 IRF2BP2 SDHC IGHM CD79A CFTR IGLL1 CD79B NHP2 EPG5 ACP5 MAN2B1 MTHFD1 BLNK LCK NFE2L2 AGL SLC46A1 LYST XIAP DKC1 IL12RB1 IL7R XIAP EPG5 SPATA5 POLE PIK3CD TTC7A NCF1 RTEL1 CD40 RNF168 IL2RB RAG2 PARN LMNB2 UROS WRAP53 CD19 NPM1 PTEN TNFRSF13C CORO1A PIK3R1 PRKDC CR2 SBDS EP300 PIK3CD CD40LG ICOS PKP1 KLLN RBCK1 ADA UNC119 SMARCAL1 ATRX USF3 BCR NCF2 CR2 RAG1 PRPS1 SDHD IL2RA IL2RG RAG2 PARN CHD1 AK2 TTC7A NOP10 CREBBP IL2RG PNP FOXN1 DOCK2 SH2D1A WIPF1 CD3D LETM1 CTC1 HYOU1 COMT TBX1 TBCE PGM3 RTEL1 IL7R MS4A1 NFKB2 ORAI1 CD19 EXTL3 TERC MYC MYD88 BUB1B CUL4B ADA2 IKBKG MBTPS2 TNFRSF13B RAG1 SP110 IL21 TLR3 CYBA XRCC4 LAMTOR2 TTC37 TERT PIK3CA SKIV2L IFNGR2 MEIS2 TFRC LAT DCLRE1C CD81 CARD9 UNC93B1 AP3D1 RTEL1 RAG1 NFKB1 SEC23B TNFRSF1B CTBP1 TRAF3 CTLA4 DNMT3B TGFB1 EFL1 FGFRL1 MAGT1 IL12B SRP54 TINF2 BTK FRAS1 GATA1 CARD11 RMRP WAS KNSTRN MAPK1 MS4A1 TERT PTPRC SDHB HBB TCF3 AKT1 ICOS DCTN4 USB1 DKC1 TNFRSF13B HIRA IKBKG TNFSF12 PIK3R1 ADA CD19 SKIV2L CCDC47 JAK3 IVNS1ABP LIG4 STAT1 CHD1 AICDA RAC2 ACD LAMTOR2 TNFSF12 STIM1 TBK1 CRKL IRF8 IRF7 STAT1
SNP 0