SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation Y181V

Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene

There are 3 clinical trials

Clinical Trials


1 A Multicenter, Single Arm, Open-Label Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients

This study is a Phase II single arm, open-label, multicenter, study of 50 human immunodeficiency virus-1 (HIV) infected adult patients, all of whom will receive etravirine (ETR) 400mg and DRV/r 800/100mg each given orally once daily. This trial is designed to evaluate the efficacy of the aforementioned ARV regimen, as measured by the percentage of patients with HIV RNA <50 copies/mL at 48 weeks, in early treatment-experienced HIV-infected patients. In addition to general safety parameter measurements, this trial will also assess changes in metabolic, inflammatory, immune restoration, and bone markers. Screening will occur over a 6-week period. The primary endpoint will be assessed at Week 48, and the treatment period is 48 weeks. The end of study endpoint will be met by either completing the Week 48 visit, or by early termination from the study for any reason.

NCT01199939
Conditions
  1. Human Immunodeficiency Virus (HIV)
Interventions
  1. Drug: Etravirine
  2. Drug: Ritonavir
  3. Drug: Darunavir
MeSH:Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes
HPO:Immunodeficiency

Inclusion Criteria: - Male or female patients, aged 18 years or above - Patients with documented HIV-1 infection - On current HAART regimen for at least 12 weeks continuous duration at screening, and with an HIV-1 plasma viral load above 500 HIV-1 RNA copies/mL by site's currently utilized viral load assay (Note: For the purposes of this study, HAART is defined as treatment with a combination of 3 or more HIV antiretroviral medications from at least 2 different classes of medications (NRTIs, NNRTIs, PIs, integrase inhibitors, CCR5 antagonists, fusion inhibitors)) - No more than 2 previous virologic failures while on PI-containing HAART regimens where virologic failure is generally defined as either a lack of suppression of the subjects' viral load to lower limit of quantification (per standard assay historically used in care) after 24 weeks of treatment or, rebound of a previously suppressed viral load (undetectable per investigator's standard of care) to detectable limits and without demonstrated re-suppression on the same regimen - Demonstrated phenotypic sensitivity to both etravirine and darunavir based on resistance testing at Screening (FC= 2.9 for etravirine and FC = 10.0 for darunavir using the PhenoSense GT) - The absence of all of the following Resistance Associated Mutations (RAMS) at baseline: For Darunavir: V11I, V32I, L33F, I47V, I50V, I54L/M, T74P, L76V, I84V, L89V - For Etravirine: L100I, E138A, I167V, V179D, V179F, Y181I, Y181V, G190S - 7. CD4 count = 50 cells/mm3. --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- T74P --- --- L76V --- --- I84V --- --- L89V --- --- L100I --- --- E138A --- --- I167V --- --- V179D --- --- V179F --- --- Y181I --- --- Y181V ---

Primary Outcomes

Description: CVR is defined as confirmed plasma Viral Load of less than 50 human immunodeficiency virus - type 1 (HIV-1) ribonucleic acid (RNA) copies/mL.

Measure: Number of Participants With Confirmed Virologic Response (CVR) at Week 48

Time: Week 48

Secondary Outcomes

Measure: Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 4

Time: Baseline (Day 1) and Week 4

Measure: Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 8

Time: Baseline (Day 1) and Week 8

Measure: Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 12

Time: Baseline (Day 1) and Week 12

Measure: Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 16

Time: Baseline (Day 1) and Week 16

Measure: Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 20

Time: Baseline (Day 1) and Week 20

Measure: Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 24

Time: Baseline (Day 1) and Week 24

Measure: Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 30

Time: Baseline (Day 1) and Week 30

Measure: Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 36

Time: Baseline (Day 1) and Week 36

Measure: Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 42

Time: Baseline (Day 1) and Week 42

Measure: Change From Baseline in Log10 Plasma Human Immunodeficiency Virus - Type 1 (HIV-1) Viral Load at Week 48

Time: Baseline (Day 1) and Week 48

Description: CVR is defined as confirmed plasma Viral Load of less than 50 human immunodeficiency virus - type 1 (HIV-1) ribonucleic acid (RNA) copies/mL.

Measure: Time to Reach First Confirmed Virologic Response

Time: Baseline (Day 1) to Week 48

Description: Virologic Failure is defined as participant who is a rebounder or a non-responder. Rebounder participant is defined as a participant who is still in the study at Week 12 and first achieves 2 consecutive virologic responses (<50 copies/mL) followed by 2 consecutive non-responses or a discontinued participant (any reason) for which the last observed time point shows a non-response. Non responder participant is defined as a participant who is still in the study at Week 12 and never achieves 2 consecutive responses.

Measure: Number of Participants With Virologic Failure

Time: Baseline (Day 1) to Week 48

Measure: Change From Baseline in Cluster of Differentiation 4 (CD4+) and Cluster of Differentiation 8 (CD8+) Cell Counts at Week 48

Time: Baseline (Day 1) and Week 48

2 A Phase IV 48 Week, Open Label, Pilot Study of Darunavir Boosted by Cobicistat in Combination With Rilpivirine to Treat HIV+ Naïve Subjects (PREZENT)

Current HIV treatment guidelines recommend the use of triple-drug therapy (two nucleoside reverse transcriptase inhibitors and either a protease inhibitor, non-nucleoside reverse transcriptase inhibitor, or an integrase inhibitor) for the treatment of antiretroviral (ARV)-naïve patients. With the introduction of highly active antiretroviral therapy (HAART), patients with HIV are living much longer. With the increasing lifespan of persons with HIV, long-term complications from therapy as well as the occurrence of co-morbidities with aging have prompted HCPs to re-think the current treatment paradigm and consider novel combinations of ARVs. All of the currently approved HIV antiretrovirals have been implicated in causing long-term toxicities; however the greatest body of evidence for long-term metabolic effects has implicated the nucleoside reverse transcriptase (NRTI) class. By utilizing a non-NRTI treatment regimen, it is hypothesized that many of these long-term metabolic effects (renal toxicity, bone loss, body fat changes) can be delayed or avoided altogether. The clinical data on novel combinations is currently limited but rapidly growing and has included several combinations that have utilized darunavir. This study will be the first of its kind using the unique combination of darunavir/cobicistat and rilpivirine. Currently, this drug combination is not a recommended option for first time treatment of HIV

NCT02404233
Conditions
  1. HIV Positive
Interventions
  1. Drug: darunavir/cobicistat
  2. Drug: rilpivirine
MeSH:HIV Seropositivity

Exclusion Criteria 1. Patient with active AIDS-defining opportunistic infection or disease according to the 1993 CDC AIDS surveillance definition (Clinical Category C) in the 30 days prior to baseline and that, in the opinion of the investigator, would preclude the patient from participating in the study (See Appendix C). 2. Patient has none of the following darunavir-associated RAMs: V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V 3. Having documented genotypic evidence of NNRTI resistance at screening or from historical data available in the source documents, i.e. at least one of the NNRTI rams from the following list; K101E, K101P, E138A, E138G, E138K, E138R, E138Q, , V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I, M230L, or the combination of the K103N and L100I. --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- I54M --- --- T74P --- --- L76V --- --- I84V --- --- L89V --- --- K101E --- --- K101P --- --- E138A --- --- E138G --- --- E138K --- --- E138R --- --- E138Q --- --- V179L --- --- Y181C --- --- Y181I --- --- Y181V ---

Primary Outcomes

Measure: Proportion of patients with plasma HIV-1 RNA <50 copies/mL

Time: up to weeks 48

Secondary Outcomes

Measure: Proportion of patients with plasma HIV-1 RNA <400 copies/mL at each time point evaluated

Time: At week 4, week 12, week 24, week 36, week 48

Measure: Number of weeks until HIV RNA <400 copies/mL and <50 copies/mL, respectively

Time: At week 4, week 12, week 24

3 A Phase IV, Open-label Single-arm Study Investigating the Pharmacokinetics and Pharmacodynamics of the Antiretroviral Combination of Rilpivirine and Ritonavirboosted Darunavir in Therapy-naive HIV-1 Infected Patients.

For patients who are starting to take antiretroviral medication (to treat HIV) for the first time, there are now a variety of different medicines which may be taken together as a combination in order to form an effective treatment which suppresses the virus for prolonged periods of time. Currently, national guidelines recommend the use of two different drugs of one type (the nucleoside/ nucleotide reverse transcriptase inhibitors, NRTI often known as "nukes") with a third drug from one of two other types (either a nonnucleoside reverse transcriptase inhibitor, known as an NNRTI or "nonnuke", or a protease inhibitor, known as a PI) to form a treatment regime of three active drugs. In the UK and Europe, all PIs are given in combination with a small dose of a second PI, ritonavir, which has the effect of boosting the levels of the active PI in the bloodstream. The investigators know from both research studies and patient experience in clinic that a combination of a ritonavirboosted PI with an NNRTI achieves similar results in suppressing the HIV virus, compared to the use of either a PI or NNRTI with 2 NRTI as described above. In this study, the investigators will observe the combination of two licensed antiretroviral medications, ritonavirboosted darunavir(DRV/r) and rilpivirine (RPV), in suppressing virus when given to patients who are commencing treatment for HIV infection for the first time. Both of these drugs are licensed for treatment of patients with HIV in the UK and Europe, and are currently in standard clinical use. The study will monitor this treatment over the first 48 weeks. The investigators will also examine the levels of both drugs in the bloodstream during the first 4 weeks of starting this regimen, to confirm that they remain at levels which the investigators know to be effective against the virus.

NCT01736761
Conditions
  1. HIV
Interventions
  1. Drug: Darunavir, Ritonavir and Rilpivirine

- Disallowed concomitant medication as per the summary of product characteristics for darunavir or rilpivirine (see section 5.2). - Any genotypic resistance mutations on screening or prior tests to darunavir (V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V) or rilpivirine (K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, H221Y, F227C, M230I, and M230L). --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54M --- --- I54L --- --- T74P --- --- L76V --- --- I84V --- --- L89V --- --- K101E --- --- K101P --- --- E138A --- --- E138G --- --- E138K --- --- E138R --- --- E138Q --- --- V179L --- --- Y181C --- --- Y181I --- --- Y181V ---

Primary Outcomes

Description: To describe the rate of virologic suppression after 48 weeks of therapy with the study regime. This will be measured by the proportion of patients with HIV-1 RNA ≤ 40 copies/mL at week 48

Measure: Virologic suppression after 48 weeks of therapy with the study regime

Time: 48 weeks

Secondary Outcomes

Description: The proportion of enrolled patients with a reduction from baseline in HIV-1 RNA >1 log10 copies /mL at weeks 4, 8, 12 and proportion with HIV-1 RNA ≤400 copies/mL at week 24.

Measure: To explore the virologic response to this combination rilpivirine and ritonavir-boosted darunavir at weeks 4, 8, 12 and 24 of therapy.

Time: 24 weeks

Other Outcomes

Description: The PK parameters (Cmax, C24, AUC0-24, and t1/2) for darunavir, rilpivirine and ritonavir at steady-state on day 28

Measure: To investigate the plasma pharmacokinetics of darunavir, ritonavir and rilpivirine when given in combination

Time: Day 28


HPO Nodes


HP:0002721: Immunodeficiency
Genes 269
CHD7 ACP5 JAK3 TNFRSF4 NFE2L2 NFKB2 SRP54 MS4A1 LCK STAT1 EPG5 PRPS1 CUL4B CD19 MEIS2 CCDC47 GATA1 CD3E CTPS1 POLE ARVCF CDH23 ATM IRAK4 PRKDC RREB1 RAG2 RAG2 SLC46A1 PGM3 FOXN1 IL2RG LMNB2 CTBP1 JMJD1C PIK3CD CREBBP HYOU1 FCGR3A TBX1 PNP SPATA5 UNG TNFSF12 TERT PTEN MALT1 TBX1 CD81 UNC119 WIPF1 TNFRSF1B PARN NSD2 TTC7A HIRA SPATA5 GP1BB GATA2 ZBTB24 IRF7 CD19 CD81 UNC93B1 EP300 TNFRSF13B SEC24C IL2RB TRAF3 CRKL DCLRE1C CDC42 IL7R DCTN4 CLCA4 ATRX SIK3 IGLL1 SEC23B CHD1 AK2 XRCC4 TCF3 IGHM CD79A PIK3R1 NOP10 MS4A1 CD79B BCL11B BUB1B AGL IVNS1ABP TTC37 PTPRC FOXN1 TNFRSF13C KNSTRN TYK2 TINF2 BCL10 RAG1 RNF168 RTEL1 CYBA IL7R USB1 CD3G PKP1 RAC2 USF3 CR2 CARD11 LAMTOR2 CYBB POLE ICOS DNAJC21 SH2D1A DNMT3B IL21 ADA CPLX1 IL2RA PIK3CA PGM3 LYST CD3D CDCA7 PIK3R1 ICOS FRAS1 LIG4 CARD9 SDHC DCLRE1C DNMT3B NCF1 RAG1 ORAI1 ACD SKIV2L IL2RG ZBTB24 TINF2 MAGT1 CD40 IKBKG TNFRSF13B WAS CR2 TFRC NFKB1 FGFRL1 USP8 CD247 RMRP WRAP53 UFD1 IKBKG AP3D1 DKC1 IL12RB1 IL12B RTEL1 SHANK3 ISG15 STAT1 MBTPS2 IRF8 RMRP TNFRSF13C NFKB1 SMARCAL1 IRF8 TERT MYC RAG1 BTK RNF168 SP110 NFKB2 PIK3CD IKBKB RBCK1 LAT ADA HELLS XRCC4 DOCK2 CDC42 TICAM1 MTHFD1 SKIV2L RAG2 STAT1 ANTXR2 IRAK4 CD40LG IFNGR1 AICDA DKC1 SDHB IKZF1 RAB27A CD28 CREBBP MYD88 TLR3 CTC1 ADA2 NCF2 STIM1 LYST IRF2BP2 AKT1 CTLA4 LETM1 STX1A TNFRSF13C TBK1 CORO1A CFTR SBDS WHCR ICOS EFL1 TERC XIAP TTC7A RAG1 UROS LIG4 PARN AK2 BCR DKC1 SDHD LRRC8A KLLN HBB LRBA TGFB1 MAN2B1 NHP2 NHEJ1 NPM1 EXTL3 EPG5 MAN2B1 COMT PRKCD BLNK CR2 TBCE IL2RG CTLA4 RTEL1 MMUT LAMTOR2 TNFSF12 IFNGR2 MAPK1 IL21R ACTB CHD1 CD19 STK4 XIAP
SNP 0