SNPMiner Trials (Home Page)
Report for Mutation Y143C
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 A Pilot Efficacy and Safety Trial of Raltegravir Plus Darunavir/Ritonavir for Treatment-Naive HIV-1-Infected Subjects
The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.
NCT00830804 HIV-1 Infections Drug: Raltegravir Drug: Darunavir/Ritonavir
- Screening HIV genotype obtained any time prior to study entry with more than one DRV resistance-associated mutation [RAM] (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, I84V, and L89V) or L76V alone - Known major integrase inhibitor RAM(s), including N155H, Q148H/R/K, Y143C/R, and G140S - Severe renal insufficiency requiring hemodialysis or peritoneal dialysis - Treatment with immunomodulators within 30 days prior to study entry. --- V11I --- --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- I54M --- --- T74P --- --- I84V --- --- L89V --- --- L76V --- --- N155H --- --- Q148H --- --- Y143C ---
Primary Outcomes
Description: Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA >= 1000 copies/ml or confirmed rebound from the week 4 value by >0.5 log10 copies/ml (for subjects with week 4 value <= 50 copies/ml, confirmed rebound to >50 copies/ml); at week 24 or later, confirmed value > 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.
Measure: Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24 Time: From start of study treatment to week 24Secondary Outcomes
Description: The proportion of participants with virologic failure (see primary outcome measure for definition) and/or premature treatment discontinuation/modification and/or death was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.
Measure: Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24 Time: From start of study treatment to Week 24Description: Results report the week 1 change from baseline (week 1 - baseline) in HIV-1 RNA. Baseline HIV-1 RNA was computed as the mean of the log10 HIV-1 RNA values at pre-entry and study entry.
Measure: Change in Plasma HIV-1 RNA From Baseline to Week 1 Time: Baseline and week 1Description: Results report the percentage of participants with plasma HIV-1 RNA < 50 copies/ml or <200 copies/ml at week 24.
Measure: Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24 Time: From start of study treatment to week 24Description: Results report the percentage of participants with plasma HIV-1 RNA <50 copies/ml or <200 copies/ml at week 48.
Measure: Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48 Time: From start of study treatment to week 48Description: Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Results report the percentage of participants who had grade 3 or higher events, or events of any grade which led to a permanent change or discontinuation of study treatment, which occurred any time from start of treatment to end of treatment.
Measure: Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment Time: From start of study treatment to week 52Description: Results report the number of participants who had resistance to non-nucleoside reverse transciptase inhibitors (NNRTI), nucleoside reverse transciptase inhibitors (NRTI) and protease inbitors (PI) based on genotypic resistance testing done prior to participant's entry into the study. Participants are classified into one (and only one category) based on the maximum number of drug class resistance seen for the participant.
Measure: Number of Participants With Pretreatment Drug Resistance Time: At screeningDescription: Results report the number of participants who had integrase resistance mutation(s) detected at the time of virologic failure.
Measure: Number of Participants With Integrase Drug Resistance at Virologic Failure Time: From 12 weeks after starting study treatment to week 52Description: Results report the number of participants who had protease resistance mutation(s) detected at the time of virologic failure.
Measure: Number of Participants With Protease Drug Resistance at Virologic Failure Time: From 12 weeks after starting study treatment to week 52Description: At each study visit, adherence was measured in terms of the number of missed doses each participant had over a 4-day recall for each drug. Adherence for all study visit weeks were combined for an overall measure of adherence. Participants who had zero missed doses on all weeks in all drugs while on study were classified as having an overall "perfect" adherence.
Measure: Number of Participants With Perfect Overall Adherence by Self Report Time: From one week after starting study treatment to week 52Description: Results report the week 24 change from week 0 (week 24 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.
Measure: Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 24 Time: From start of study treatment through week 24Description: Results report the week 24 change from week 0 (week 24 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.
Measure: Change in Fasting Low-density Lipoprotein at Week 24 Time: From start of study treatment through week 24Description: Results report the week 48 change from week 0 (week 48 - week 0) fasting total cholesterol, high-density lipoprotein and triglyceride.
Measure: Changes in Fasting Total Cholesterol, High-density Lipoprotein and Triglyceride at Week 48 Time: From start of study treatment through week 48Description: Results report the week 48 change from week 0 (week 48 - week 0) fasting low-density lipoprotein (LDL). For participants whose calculated fasting LDL and direct fasting LDL were both reported, only the calculated fasting LDL was used. Direct fasting LDL was reported when the participant had high fasting triglyceride.
Measure: Change in Fasting Low-density Lipoprotein at Week 48 Time: From start of study treatment through week 48Description: Results report the week 48 change from baseline (week 48 - baseline) in CD4 count. Baseline CD4 count was computed as the mean of CD4 count values at pre-entry and study entry.
Measure: Change in CD4 Count at Week 48 Time: From start of study treatment through week 48Description: Plasma trough concentrations (ng/ml) of Raltegravir (RAL) below the detection limit (10 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 9-15 hours after the last RAL dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.
Measure: Plasma Trough Concentration of Raltegravir Time: From start of study treatment to week 52Description: Plasma trough concentrations (ng/ml) of Darunavir (DRV) below the detection limit (50 ng/ml) were replaced by half the corresponding lower limit of quantitation. Geometric mean of trough concentrations obtained within the prescribed trough time (within 20-28 hours after the last DRV dose) was computed for each participant. For participants who experienced virologic failure (see primary outcome measure definition), only those concentrations on or before virologic failure confirmation were used in the geometric mean computation.
Measure: Plasma Trough Concentration of Darunavir Time: From start of study treatment to week 52