SNPMiner Trials by Shray Alag
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SNPMiner Trials (Home Page)
Report for Mutation V151L
Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene
There are 2 clinical trials
Clinical Trials
1 A Randomized Comparative Phase II Trial Evaluating the Capacity of the Dual Combination Doravirine/Raltegravir to Maintain Virological Success in HIV-1 Infected Patients With an HIV-RNA Plasma Viremia Below 50 Copies/mL Under a Current Antiretroviral Regimen
The objective of antiretroviral therapy (ART) is the maintenance of HIV viral suppression, the optimal condition to prevent disease progression, to optimize immune restoration, to prevent the development of viral resistance and to reduce viral transmission. Antiretroviral therapy has to be maintained long life over decades in the absence of strategies for HIV cure. This is why the long-term cumulative toxicity of ARV drugs is a major issue. Indeed as a consequence of potent ART strategies, in 2011 over 88% of patients on ART in the French Hospital database (ANRS CO4 FHDH) achieved viral suppression with HIV-RNA plasma viral load < 50 copies/mL and nearly 60% had CD4 > 500/mm3. As a consequence of massive reduction of mortality and morbidity related to HIV, infected patients are aging with 40% of patients over 50 years of age in the ANRS CO4 FHDH. The current standard-of-care for antiretroviral therapy consists in a triple drug combination with two nucleoside reverse transcriptase inhibitors (NRTIs) plus either a non-nucleoside reverse transcriptase inhibitor (NNRTI), a protease inhibitor (PI), or an integrase inhibitor (INSTI). NRTIs and PIs have been associated to cumulative long-term toxicity such as bone and renal disorders related to tenofovir and increased cardio-vascular risk with PIs. In general population, aging is associated with well-known comorbidities such as bone demineralization, increased incidence of cardio or cerebrovascular disease, diabetes, renal dysfunction. HIV infected patients are at a greater risk for such abnormalities. Another crucial concern is the high probability of drug-drug interactions in HIV-infected patients, between ART and comedications. Alternative strategies are needed, which must address the following questions: how to maintain the control of HIV viral replication while minimizing the occurrence of long-term clinical and metabolic complications, and minimizing the risk of drug-drug interactions? This study is an open label, randomized, switch study over 96 weeks in which virally suppressed patients on a stable combined ART regimen will be randomized (2:1) to an immediate switch to doravirine/raltegravir (immediate switch group) or to the maintaining of their current ART followed by a switch to doravirine/raltegravir at W48 (delayed switch group). Patients will be followed during 96 weeks.
NCT04513626 Conditions
- HIV Infections
Interventions
- Drug: DORAVIRINE 100 MG [Pifeltro]
MeSH:HIV Infections
- Mutations associated to doravirine resistance are: V106A/M, Y188L, G190E/S, M230L, F227C, at least 2 among: A98G, L100I, K101E, V106I, E138K, Y181C/V, G190A or H221Y - Mutations associated to raltegravir resistance are: T66A/K, E92Q, G118R, F121Y, G140A/S Y143A/C/G/H/R/S, Q148E/G/H/K/R, V151L, N155H/S/T, E157Q, S230R, R263K, L74 F/I + V75I. --- V106A --- --- Y188L --- --- G190E --- --- M230L --- --- F227C --- --- A98G --- --- L100I --- --- K101E --- --- V106I --- --- E138K --- --- Y181C --- --- G190A --- --- H221Y --- --- T66A --- --- E92Q --- --- G118R --- --- F121Y --- --- G140A --- --- Y143A --- --- Q148E --- --- V151L ---
Primary Outcomes
Description: Measure of plasma viral load assessed by RNA quantification using COBA 6800 system (Roche)
Measure: Measure the virological efficacy at week 48 of once daily doravirine plus raltegravir dual therapy to assess the effectiveness of the dual therapy DORAL to maintain the virological success to W48 Time: 48 weeks2 Dolutegravir + Rilpivirine Switch Study (DORISS): Pilot and Noninferiority Trial Comparing Dolutegravir + Rilpivirine vs. Continued HAART (Highly Active Antiretroviral Therapy) in Patients With Plasma HIV RNA ≤ 50 Copies/mL for at Least 2 Years
The primary objective of the study is to evaluate the capacity of Dolutegravir + Rilpivirine vs. continued triple combination HAART to maintain plasma HIV RNA ≤ 50 copies/ml throughout 24 weeks in patients with plasma HIV RNA ≤ 50 copies/mL for at least 2 years under conventional HAART (2 NNRTI + 3rd agent). The main secondary objectives are the following: - % of virologic success (plasma viral load ≤ 50 copies/mL) at W24 and W48 - % of patients who maintain a plasma viral load ≤ 50 copies / ml from D0 to W48 - % of virological failure defined by two consecutive plasma viral load > 50 copies/mL - Profile of genotypic resistance in case of virological failure. The trial will be conducted according to the design below, in 3 steps: - Step 1: enrollment of 80 patients (40 in each arm) - Step 2: enrollment on hold until W16 data from the 40 patients enrolled in the intervention arm have been analyzed. - Step 3: resumption and completion of enrollment if conditions for resuming enrollment at the end of step 2 are fulfilled, i.e. if the percentage of patients randomized to the intervention arm who have a plasma viral load ≤ 50 copies/mL from D0 to W16 is significantly > 70%, which translates in a maximum of 6 virologic failures.
NCT02069834 Conditions
- HIV Infection
- HAART-treated
- Virologically Controlled
Interventions
- Drug: Arm 1 (intervention)
- Drug: Arm 2 (control)
MeSH:HIV Infections
- No mutation (either on pre-ART genotype or on DNA genotype at screening) among the following: T66K, G118R, V151L, S153F/Y, R263K, T66K + L74M, E92Q + N155H, Q148R +N155H, Q148H/K/R with at least one mutation of L74I or E138A/K/T or G140A/C/S - Negative HBs Ag - Informed consent form signed by patient and investigator - A specific consent for the pharmacokinetic substudy will be signed by the 10 patients of the pilot phase of the trial who will be randomized to the Dolutegravir + Rilpivirine arm and will volunteer for this PK study - Patient covered with health insurance - Effective contraception Exclusion Criteria: - HIV-2 infection - Dialysis or severe renal failure (creatinine clearance < 30 ml/min) - History of decompensated liver disease - History of HIV-associated neurocognitive disorders - AST or ALT > 5 x ULN - Positive HBc Ac and negative HBs Ac - Patient receiving a proton pump inhibitor that cannot be switched to another anti-secretory drug - Current pregnancy or breastfeeding - Patient involved in another research that precludes enrolment in another trial - Patient under guardianship, or deprived of liberty by a court or administrative decision. --- T66K --- --- G118R --- --- V151L ---
Primary Outcomes
Measure: Pilot phase: Percentage of patients with plasma viral load ≤ 50 copies HIV-RNA/ml from D0 (Day 0) to W16 (Week 16) Time: Week 16Measure: Non-inferiority phase: Percentage of patients with plasma HIV RNA maintained ≤ 50 copies/mL throughout 24 weeks Time: Week 24
Secondary Outcomes
Measure: Percentage of patients with plasma viral load ≤50 HIV RNA copies/mL at Week 24 and Week 48 Time: Week 48Measure: Percentage of patients with plasma viral load ≤50 HIV RNA copies/mL from Day 0 to Week 48 Time: Week 48
Measure: Percentage of virologic failure, defined as 2 consecutive plasma HIV RNA > 50 copies/mL Time: Week 48
Measure: Measure of the profile of genotypic resistance in plasma in case of virologic failure Time: Week 48
Measure: Percentage of patients who discontinued or changed the strategy of the study Time: Week 48
Description: Evolution of the HIV-DNA between Day 0 and week 48
Measure: Measure of the HIV-DNA between day 0 and week 48 Time: W48Description: Evolution of CD4 lymphocytes (average) at Week 24 compared to Day 0
Measure: Measure of CD4 lymphocytes at week 24 compared to day 0 Time: Week 24Description: Evolution of CD4 lymphocytes (average) at Week 48 compared to Day0
Measure: Measure of CD4 lymphocytes at Week 48 compared to Day 0 Time: Week 48Description: Adverse events : incidence, grade and relation to study medication of all adverse events, of grade 2 to 4 events
Measure: Number of patients with adverse events of grade 2 to 4 Time: Week 48Description: Mean changes in serum plasma lipid parameters at Week 24 compared to Day 0
Measure: Measure of changes in serum plasma lipid parameters at week 24 compared to Day 0 Time: Week 24Description: Mean changes in serum plasma lipid parameters at Week 48 compared to Day 0
Measure: Measure of changes in serum lipid parameters at week 48 to Day 0 Time: Week 48Description: Changes in fat mass distribution at Week 24 compared to Day 0
Measure: Measure of changes in fat mass distribution at week 24 compared to Day 0 Time: Week 24Description: Changes in fat mass distribution at Week 48 compared to Day 0
Measure: Measure of changes in fat mass distribution at Week 48 compared to Day 0 Time: Week 48Description: Evolution of adherence to treatment at Week 24 compared to Day 0 assessed by a validated questionnaire
Measure: Measure of adherence to treatment at Week 24 compared to Day 0 Time: Week 24Description: Evolution of adherence to treatment at Week 48 compared to Day 0 assessed by a validated questionnaire
Measure: Measure of adherence to treatment at Week 48 compared to Day 0 Time: Week 48Description: Assessment of patient satisfaction for their treatment at D0 by questionnaire
Measure: Measure of patient satisfaction for their treatment at Day 0 Time: Day 0Description: Assessment of patient satisfaction for their treatment at Week 24 by questionnaire
Measure: Measure of patient satisfaction for their treatment at Week 24 Time: Week 24Description: Assessment of patient satisfaction for their treatment at Week 48 by questionnaire
Measure: Measure of patient satisfaction for their treatment at Week 48 Time: Week 48Description: Changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 24 compared to Day 0 .
Measure: Measure of changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 24 compared to Day 0 . Time: Week 24Description: Changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 48 compared to Day 0 .
Measure: Measure of changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 48 compared to Day 0 . Time: Week 48Description: Analysis PK (PharmacoKinetic) / PD (Pharmaodynamic) of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 4
Measure: Measure of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 4 Time: Week 4Description: Analysis PK / PD of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 24
Measure: Measure of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 24 Time: Week 24Measure: Measure of the profile of genotypic resistance in plasma in case of virologic failure Time: Week 24
Measure: Percentage of virologic failure, defined as 2 consecutive plasma HIV RNA > 50 copies/mL Time: Week 24