SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation L10F

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 4 clinical trials

Clinical Trials


1 A Randomized, Open-Label Study Assessing Safety, Tolerability and Efficacy of an Induction-Maintenance Treatment Strategy Including Lopinavir/Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine Versus Efavirenz Plus Tenofovir Disoproxil Fumarate and Emtricitabine in Antiviral-naïve HIV-1/HCV Co-Infected Subjects

The purpose of this study is to determine whether a simplified lopinavir/ritonavir-based therapy will continue to keep the viral load at very low levels after initial treatment with a combination of Kaletra (lopinavir/ritonavir) plus tenofovir and emtricitabine.

NCT00121017
Conditions
  1. HIV Infection
  2. Hepatitis C
Interventions
  1. Drug: Kaletra (lopinavir/ritonavir)
  2. Drug: Sustiva (efavirenz)
  3. Drug: Truvada (emtricitabine/tenofovir disoproxil fumarate)
MeSH:Hepatitis C

- The screening HIV-1 genotype resistance report suggests resistance or possible resistance to the study RTI(s) or lopinavir/ritonavir; Evidence of possible resistance to efavirenz; Presence of one of the following mutations: RT L1001, K103N, V106A or M, V108I, Y181C or I, Y188L, G190A or S, P225H, M230L; Evidence of possible resistance to emtricitabine or lamivudine; Presence of one of the following mutations: RTm184V or I; Evidence of possible resistance to tenofovir; Presence of RT K65R or insertion at codon 69, or Presence of 2 or more of the following mutations: RTm41L, D67N, K70R, L210W; any change at T215, K219Q or evidence of possible resistance to lopinavir/ritonavir; Presence of one or more of the following mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, 190M or Presence of 3 or more of the following mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L; any change at I54, A71V or T, G73S. --- K103N --- --- V106A --- --- V108I --- --- Y181C --- --- Y188L --- --- G190A --- --- P225H --- --- M230L --- --- K65R --- --- D67N --- --- K70R --- --- L210W --- --- K219Q --- --- I47V --- --- G48V --- --- I50V --- --- V82A --- --- I84V --- --- L10F ---

Primary Outcomes

Measure: The proportion of subjects with a plasma HIV-1 RNA level below 50 copies/mL at Week 96.

Secondary Outcomes

Measure: Vital signs

Measure: Physical examinations

Measure: Clinical laboratory tests

2 A Phase 3, Randomized, Open-Label Study of Lopinavir/Ritonavir (LPV/r) Tablets 800/200 Milligram (mg) Once-Daily (QD) Versus 400/100 mg Twice-Daily (BID) When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) in Antiretroviral-Experienced, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects

The purpose of this study was to compare the safety, tolerability, and antiviral activity of once-daily (QD) and twice-daily (BID) dosing of the lopinavir/ritonavir (LPV/r) tablet formulation in combination with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) in antiretroviral-experienced human immunodeficiency virus type 1 infected subjects with detectable viral load while receiving their current antiretroviral therapy.

NCT00358917
Conditions
  1. Human Immunodeficiency Virus Infections
Interventions
  1. Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
  2. Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
MeSH:Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes
HPO:Immunodeficiency

Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir. Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.. Percentage of Participants With New Primary Protease Mutations at Week 48. --- L10F ---

Primary Outcomes

Description: A participant was classified as a responder at the first of 2 consecutive human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/mL. The participant continued to be a responder until 2 consecutive values >=50 copies/mL were reached, until the final value if that value was >=50 copies/mL, or until discontinuation or death.

Measure: Percentage of Participants Responding at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm

Time: Week 48 (End of Study)

Secondary Outcomes

Measure: Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 50 Copies/Milliliter (mL) at Week 48

Time: Week 48 (End of Study)

Measure: Mean Change From Baseline to Week 48 in Cluster of Differentiation 4 Single-Positive Thymocyte (CD4+ T) Cell Counts

Time: Week 48 (End of Study)

Description: Substitutions considered in the analysis were L10F/I/R/V, K20M/N/R, L24I, L33F, M36I, I47V, G48V, I54L/T/V, V82A/C/F/S/T, and I84V as defined in the proposed United States Package Insert.

Measure: Virologic Response (HIV-1 RNA <50 Copies/mL) at Week 48 for Participants With 0-2 Protease Inhibitor Substitutions at Baseline Associated With Reduced Response to Lopinavir/Ritonavir

Time: Week 48 (End of Study)

Description: Emergence of new primary protease inhibitor mutations (i.e., mutations at codons 30, 32, 48, 50, 82, 84, and 90 that were not present at baseline).

Measure: Percentage of Participants With New Primary Protease Mutations at Week 48

Time: Week 48 (End of Study)

3 Open-label, Comparative and Randomised Pilot Study to Evaluate the Efficacy and Safety of Saquinavir/Ritonavir in Single Therapy vs Standard HAART Therapy as Maintenance Therapy.

Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance therapy, compared to standard HAART therapies.

NCT00379405
Conditions
  1. HIV Infections
Interventions
  1. Drug: Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours
MeSH:HIV Infections

- Documented existence of any of the primary mutations in the protease gene or 3 or more of the following: L10F/I/R/V, K20M/R, M36I/V, I54L/T/V, L63P, A71T/V , V82A/F/T/S, I84A/V OR L90M. --- L10F ---

Primary Outcomes

Measure: Virological response: Viral Load

Time: weeks 24 and 48

Secondary Outcomes

Measure: CD4 and CD8 lymphocyte count.

Time: weeks 24 and 48

Measure: Physical Exploration: including weight, height, index waist/hip (the abdominal perimeter is measured between the last floating rib and the iliac crest), assessment of changes in body fat distribution,...

Time: weeks 24 and 48

Measure: Karnofsky Index.

Time: weeks 24 and 48

Measure: Adverse events.

Time: during the 48 weeks of follow-up

Measure: Trough plasma concentrations of Saquinavir.

Time: during the 48 weeks of follow-up

Measure: Lipid study in plasma (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides)

Time: during the 48 weeks of follow-up

Measure: Serology for Hepatitis B and C virus.

Time: at baseline visit

Measure: Assessment of treatment adherence.

Time: at baseline and weeks 4, 12, 24, 36 and 48

Measure: Assessment of quality of life (by means of the MOS-HIV questionnaire).

Time: at baseline and weeks 4, 12, 24, 36 and 48

Measure: Genotype if virological failure.

Time: at any time of study if it is necessary

4 A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects

The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1 infected subjects.

NCT00711009
Conditions
  1. Human Immunodeficiency Virus Infection
Interventions
  1. Drug: lopinavir/ritonavir (LPV/r)
  2. Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
  3. Drug: raltegravir (RAL)
MeSH:Virus Diseases Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes
HPO:Immunodeficiency

Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S.. Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey. --- I47V --- --- G48V --- --- I50V --- --- V82A --- --- I84V --- --- L90M --- --- L10F ---

Primary Outcomes

Description: A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.

Measure: Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm

Time: Baseline to Week 48

Description: Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent, moderate or severe drug-related adverse events that occurred in at least 2% of participants in either treatment arm are presented.

Measure: Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events

Time: Week 96

Description: Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.

Measure: Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values

Time: Baseline to Week 96

Secondary Outcomes

Description: A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.

Measure: Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm

Time: Baseline to Week 96

Measure: Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit

Time: Baseline to Week 96

Description: Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL.

Measure: Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672

Time: Baseline to Week 96

Description: Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred.

Measure: Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.

Time: Baseline to Week 96

Description: Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S.

Measure: Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir

Time: Baseline to Week 96

Description: The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement.

Measure: Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey

Time: Baseline to Week 96

Description: The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement.

Measure: Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey

Time: Baseline to Week 96

Description: The Effectiveness Scale of the TSQM evaluates the participant's satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction.

Measure: Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)

Time: Week 96

Description: The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction.

Measure: Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication

Time: Week 96

Description: The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction.

Measure: Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication

Time: Week 96

Measure: Mean Change From Baseline in Hemoglobin (Grams/Liter)

Time: Baseline to Week 96

Description: Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples.

Measure: Mean Change From Baseline in Hematocrit (Fraction)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Platelet Count (x 10^9/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Neutrophils (x 10^9/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Lymphocytes (x 10^9/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Monocytes (x 10^9/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Eosinophils (x 10^9/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Basophils (x 10^9/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Creatinine (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Uric Acid (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Calcium (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Sodium (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Potassium (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Chloride (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Bicarbonate (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Albumin (Grams/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Total Protein (Grams/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Cholesterol (Micromoles/Liter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Triglycerides (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Lipase (Units/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Magnesium (Millimoles/Liter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Lactate (Millimoles/Liter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Leptin (Nanograms/Milliliter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Insulin (Picomoles/Liter)

Time: Baseline to Week 96

Description: Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density.

Measure: Mean Change From Baseline in Urine Specific Gravity

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Urine pH

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Weight (kg)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Temperature (°F)

Time: Baseline to Week 96

Description: Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant's chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Chest Measurement (cm)

Time: Baseline to Week 96

Description: Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant's waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Waist Measurement (cm)

Time: Baseline to Week 96

Description: Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Mid-Arm Measurement (cm)

Time: Baseline to Week 96

Description: Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Hips Measurement (cm)

Time: Baseline to Week 96

Description: Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Mid-Thigh Measurement (cm)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)

Time: Baseline to Week 96


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