SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation T215F

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

There are 2 clinical trials

Clinical Trials


1 A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants

The primary objective of this study is to evaluate the efficacy of switching from a regimen of 2 nucleos(t)Ide reverse transcriptase inhibitors (NRTIs) and a third agent to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing their baseline regimen in HIV-1 infected, virologically suppressed african american participants.

NCT03631732
Conditions
  1. HIV-1 Infection
Interventions
  1. Drug: B/F/TAF
  2. Drug: NRTIs
  3. Drug: Third Agent

By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.. Key Inclusion Criteria: - Self-describes as Black, African American, or mixed race, including Black - Currently receiving an antiretrovirals (ARV) regimen other than FDC of B/F/TAF that consists of any two NRTIs + allowed 3rd agent for ≥ 6 months - Allowed 3rd agents include any FDA-approved INSTI, with the exception of bictegravir, any FDA-approved NNRTI with the exception of etravirine, protease inhibitors or the CCR5 antagonist, maraviroc - If the baseline 3rd agent is dolutegravir, dosing other than 50 mg once daily is excluded - Baseline regimens containing investigational drugs or > 2 classes of ARVs are not permitted, with the exception of the pharmacologic enhancers cobicistat (taken with elvitegravir or a PI), or ritonavir (taken with a PI) - Have no documented or suspected resistance to INSTIs and no history of virologic failure on an INSTI containing regimen (2 consecutive HIV-1 RNA ≥ 50 copies/mL after achieving <50 copies/mL while on an INSTI-containing regimen) - History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded - Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit - HIV-1 RNA levels < 50 copies/mL at Screening - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance Key Exclusion Criteria: - History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R),T69-insertions, or K65R/E/N in RT - No desire to switch from current ARVs - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) - Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma, completely resected non -melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus (AIN 3). --- M184V --- --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F ---

By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.. Key Inclusion Criteria: - Self-describes as Black, African American, or mixed race, including Black - Currently receiving an antiretrovirals (ARV) regimen other than FDC of B/F/TAF that consists of any two NRTIs + allowed 3rd agent for ≥ 6 months - Allowed 3rd agents include any FDA-approved INSTI, with the exception of bictegravir, any FDA-approved NNRTI with the exception of etravirine, protease inhibitors or the CCR5 antagonist, maraviroc - If the baseline 3rd agent is dolutegravir, dosing other than 50 mg once daily is excluded - Baseline regimens containing investigational drugs or > 2 classes of ARVs are not permitted, with the exception of the pharmacologic enhancers cobicistat (taken with elvitegravir or a PI), or ritonavir (taken with a PI) - Have no documented or suspected resistance to INSTIs and no history of virologic failure on an INSTI containing regimen (2 consecutive HIV-1 RNA ≥ 50 copies/mL after achieving <50 copies/mL while on an INSTI-containing regimen) - History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded - Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit - HIV-1 RNA levels < 50 copies/mL at Screening - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance Key Exclusion Criteria: - History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R),T69-insertions, or K65R/E/N in RT - No desire to switch from current ARVs - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) - Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma, completely resected non -melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus (AIN 3). --- M184V --- --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F --- --- K219Q --- --- K65R --- --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F ---

Key Inclusion Criteria: - Self-describes as Black, African American, or mixed race, including Black - Currently receiving an antiretrovirals (ARV) regimen other than FDC of B/F/TAF that consists of any two NRTIs + allowed 3rd agent for ≥ 6 months - Allowed 3rd agents include any FDA-approved INSTI, with the exception of bictegravir, any FDA-approved NNRTI with the exception of etravirine, protease inhibitors or the CCR5 antagonist, maraviroc - If the baseline 3rd agent is dolutegravir, dosing other than 50 mg once daily is excluded - Baseline regimens containing investigational drugs or > 2 classes of ARVs are not permitted, with the exception of the pharmacologic enhancers cobicistat (taken with elvitegravir or a PI), or ritonavir (taken with a PI) - Have no documented or suspected resistance to INSTIs and no history of virologic failure on an INSTI containing regimen (2 consecutive HIV-1 RNA ≥ 50 copies/mL after achieving <50 copies/mL while on an INSTI-containing regimen) - History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded - Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit - HIV-1 RNA levels < 50 copies/mL at Screening - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance Key Exclusion Criteria: - History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R),T69-insertions, or K65R/E/N in RT - No desire to switch from current ARVs - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) - Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma, completely resected non -melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus (AIN 3). --- M184V --- --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F ---

Key Inclusion Criteria: - Self-describes as Black, African American, or mixed race, including Black - Currently receiving an antiretrovirals (ARV) regimen other than FDC of B/F/TAF that consists of any two NRTIs + allowed 3rd agent for ≥ 6 months - Allowed 3rd agents include any FDA-approved INSTI, with the exception of bictegravir, any FDA-approved NNRTI with the exception of etravirine, protease inhibitors or the CCR5 antagonist, maraviroc - If the baseline 3rd agent is dolutegravir, dosing other than 50 mg once daily is excluded - Baseline regimens containing investigational drugs or > 2 classes of ARVs are not permitted, with the exception of the pharmacologic enhancers cobicistat (taken with elvitegravir or a PI), or ritonavir (taken with a PI) - Have no documented or suspected resistance to INSTIs and no history of virologic failure on an INSTI containing regimen (2 consecutive HIV-1 RNA ≥ 50 copies/mL after achieving <50 copies/mL while on an INSTI-containing regimen) - History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT substitutions are allowed, with the following exceptions: History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT will be excluded - Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months and at least the last two HIV-1 RNA measurements prior to the Screening visit - HIV-1 RNA levels < 50 copies/mL at Screening - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance Key Exclusion Criteria: - History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R),T69-insertions, or K65R/E/N in RT - No desire to switch from current ARVs - An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening - Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or variceal bleeding) - Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) - Malignancy within 5 years of screening other than cutaneous Kaposi's sarcoma, completely resected non -melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus (AIN 3). --- M184V --- --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F --- --- K219Q --- --- K65R --- --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F ---

Primary Outcomes

Description: The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 were analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Measure: Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set

Time: Week 24

Secondary Outcomes

Description: The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 48 were analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.

Measure: Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set

Time: Week 48

Description: The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 24 were analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Measure: Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set

Time: Week 24

Description: The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 24 were analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Measure: Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Week 24 Per Protocol Analysis Set

Time: Week 24

Description: The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 48 were analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.

Measure: Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set

Time: Week 48

Description: The analysis includes values up to 1 day after permanent discontinuation of study treatment.

Measure: Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set

Time: Baseline to Week 24

Description: The analysis includes values up to 1 day after permanent discontinuation of study treatment.

Measure: Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set

Time: Baseline to Week 24

Description: The analysis includes values up to 1 day after permanent discontinuation of study treatment. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF.

Measure: Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set

Time: Baseline to Week 48

2 Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine in Virologically-suppressed Adults Living With HIV on Bictegravir/Tenofovir Alafenamide/emtricitabine-the DYAD Study

Phase 4, randomized, open-label study to evaluate the efficacy, safety and tolerability of switching virologically suppressed adults living with HIV on bictegravir/tenofovir alafenamide/emtricitabine to dolutegravir/lamivudine

NCT04585737
Conditions
  1. HIV I Infection
Interventions
  1. Drug: Dolutegravir / Lamivudine Pill
  2. Drug: Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill

Any evidence of major NRTI mutation (defined as history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), M184V/I, T69-insertions, or K65R/E/N) or presence of any major INSTI resistance-associated mutation [17] in any available prior resistance genotype assay test result 16. --- M41L --- --- D67N --- --- K70R --- --- L210W --- --- T215F ---

Primary Outcomes

Description: percentage with HIV-1 RNA ≥50 copies/mL at Week 48 in each treatment arm

Measure: The Primary outcome measure is to evaluate the efficacy of switching from B/F/TAF to DTG/3TC versus continuing B/F/TAF as determined by the proportion of participants with HIV-1 RNA ≥50 copies/mL at Week 48

Time: 48 weeks

Secondary Outcomes

Description: percentage with HIV-1 RNA ≥50 copies/mL at Weeks 12 and 24 in each treatment arm

Measure: The Secondary outcome measure is to evaluate the efficacy of switching to DTG/3TC from B/F/TAF as determined by the proportion of participants with HIV-1 RNA≥ 50 copies/mL at Weeks 12 and 24

Time: 12 and 24 weeks

Description: percentage with HIV-1 RNA<50 copies/mL at Weeks 12, 24 and 48 in each treatment arm

Measure: The secondary outcome measure is to evaluate the efficacy of switching to DTG/3TC from B/F/TAF as determined by the proportion of participants with HIV-1 RNA<50 copies/mL at Weeks 12, 24 and 48

Time: 12, 24 and 48 weeks

Description: AEs and lab abnormalities graded using DAIDS grading scale

Measure: The secondary outcome measure is to measure the Incidence and severity of adverse events and laboratory abnormalities (graded using DAIDs grading scale) through 48 weeks

Time: 48 weeks

Description: Number of participants who discontinue study treatment and reasons for discontinuation

Measure: The secondary outcome measure is to evaluate the proportion of participants that discontinue treatment through 48 weeks in each treatment arm and reasons for discontinuation

Time: 48 weeks

Description: Change from Baseline in fasting lipids at Weeks 24, and 48

Measure: The secondary outcome measure is to evaluate the effects of DTG/3TC once daily on fasting lipids over time compared to B/F/TAF through 48 weeks

Time: 48 weeks

Description: Change from Baseline in weight (kg) measured at Weeks 12, 24, and 48

Measure: The secondary outcome measure is to evaluate changes in weight (kg) in those treated with DTG/3TC vs. B/F/TAF over time

Time: 12, 24 and 48 weeks

Description: Change from Baseline in waist circumference (measured in inches) at Weeks 12, 24, and 48

Measure: The secondary outcome measure is to evaluate changes in waist circumference (inches) in those treated with DTG/3TC vs. B/F/TAF over time

Time: 12, 24 and 48 weeks

Description: Change from Baseline in weight (kg) and height (meters) will be used to assess changes in BMI (kg/m2) measured at Weeks 12, 24, and 48

Measure: The secondary outcome measure is to evaluate changes in BMI (kg/m2) in those treated with DTG/3TC vs. B/F/TAF over time

Time: 12, 24 and 48 weeks

Description: Change from Baseline in health status using the HIV-Symptoms Index questionnaire (validated 20-item questionnaire which asks subjects to rate the degree of bother they experience for each symptom in the past two weeks, the rating scale for each item ranges from 0-4 with higher values indicating greater symptom distress). This questionnaire will be administered on paper at Weeks 4, 12, 24 and 48 (or Withdrawal from the study)

Measure: The secondary outcome measure is to assess health related quality of life for subjects treated with DTG/3TC compared to B/F/TAF over time using the HIV-Symptoms Index questionnaire

Time: 4, 12, 24 and 48 weeks (or at study withdrawal)

Description: Change from baseline in treatment satisfaction using the HIV Treatment Satisfaction Questionnaire (validated 10-item questionnaire which asks subjects to rate how satisfied they are with different aspects of their HIV treatment, each item utilizes a rating scale of 0-6 with higher numbers indicating greater satisfaction). This survey will be administered on paper at Weeks 4, and 24 (or withdrawal from the study)

Measure: To assess treatment satisfaction in subjects treated with DTG/3TC compared to B/F/TAF over time using the HIV-Treatment Satisfaction Questionnaire

Time: 4 and 24 weeks (or at study withdrawal)

Description: to measure the incidence of observed genotypic resistance to ARVs for subjects meeting Virologic Rebound Criteria

Measure: To assess the number of subjects with genotypic mutations affecting any component of the treatment regimen among subjects meeting Virologic Rebound Criteria (HIV-1 RNA≥50 copies/mL X2) using HIV genotypic and ARCHIVE HIV-DNA testing

Time: 48 weeks


HPO Nodes