SNPMiner Trials (Home Page)
Report for Mutation M36I
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There are 5 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 HIV Infection Hepatitis C Drug: Kaletra (lopinavir/ritonavir) Drug: Sustiva (efavirenz) 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 --- --- K20M --- --- L24I --- --- V32I --- --- L33F --- --- M36I ---
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 signsMeasure: 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 Human Immunodeficiency Virus Infections Drug: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) 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 --- --- K20M --- --- L24I --- --- L33F --- --- M36I ---
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 HIV Infections 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 --- --- K20M --- --- M36I ---
Primary Outcomes
Measure: Virological response: Viral Load Time: weeks 24 and 48Secondary Outcomes
Measure: CD4 and CD8 lymphocyte count. Time: weeks 24 and 48Measure: 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 Human Immunodeficiency Virus Infection Drug: lopinavir/ritonavir (LPV/r) Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) Drug: raltegravir (RAL) MeSH:Acqu Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Virus Diseases
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 --- --- K20M --- --- L24I --- --- V32I --- --- L33F --- --- M36I ---
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 48Description: 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 96Description: 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 96Secondary 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 96Measure: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Measure: 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 96Measure: 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 96Description: Included in measures of metabolic toxicity
Measure: Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter) Time: Baseline to Week 96Measure: 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 96Measure: 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 96Measure: 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 96Measure: 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 96Description: Included in measures of metabolic toxicity
Measure: Mean Change From Baseline in Interleukin-6 (Nanograms/Liter) Time: Baseline to Week 96Description: Included in measures of metabolic toxicity
Measure: Mean Change From Baseline in Lactate (Millimoles/Liter) Time: Baseline to Week 96Description: Included in measures of metabolic toxicity
Measure: Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter) Time: Baseline to Week 96Description: Included in measures of metabolic toxicity
Measure: Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter) Time: Baseline to Week 96Description: Included in measures of metabolic toxicity
Measure: Mean Change From Baseline in Leptin (Nanograms/Milliliter) Time: Baseline to Week 96Description: Included in measures of metabolic toxicity
Measure: Mean Change From Baseline in Insulin (Picomoles/Liter) Time: Baseline to Week 96Description: 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 96Measure: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 96Description: 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 965 An Open-Label Phase 3B Study in HIV-Infected Individuals With Viremia on or After Their First-Line Non-Nucleoside Reverse Transcriptase Inhibitor or Integrase Inhibitor-Based Regimen and Starting a Second-Line Regimen Consisting of ATV/RTV or DRV/RTV With an Optimized NRTI Backbone
The purpose of this study is to determine the proportion of subjects with HIV-1 RNA < 50 c/mL at Week 48 in patients who failed their first line therapy containing a non-nucleoside reverse transcriptase inhibitor (NNRTI) or an integrase inhibitor
NCT01605084 HIV Drug: Atazanavir Drug: Darunavir Drug: Ritonavir Drug: Optimized NRTI backbone
An NRTI or PI (reported with or without ritonavir) with a "partially sensitive" net assessment will not be considered "fully sensitive" 4. Mentally able to participate in the study 5. Men and women ≥ 18 years old - Women of child bearing potential who engage in vaginal intercourse and who are not clinically sterilized must use highly effective methods of birth control during the study Exclusion Criteria: 1. Screening HIV genotype showing presence at baseline of any of the following Protease inhibitor (PI) Mutation Patterns associated with genotypic resistance to Atazanavir sulfate/ Ritonavir or Darunavir/Ritonavir will lead to exclusion: 1. Subjects with any darunavir associated mutations* at baseline (*V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V) 2. Subjects with a major mutation to Atazanavir sulfate consisting of N88S 3. Subjects with more than 3 of any of the following Atazanavir sulfate related mutations:D30N, M36I/V, M46I/L/T, I54V/L/T/M/A, A71V/T/I/G, G73S/A/C/T, V77I, V82A/F/T/S/I, I84V/A, N88D or L90M 2. Subjects with < 1 fully active NRTI on PhenoSense report, other than lamivudine and emtricitabine 3. Diagnosed with active tuberculosis 4. Chronic hepatitis B infection 5. Hepatitis C-positive patients who are not clinically stable or need treatment during the study period 6. --- V32I --- --- L33F --- --- I47V --- --- I50V --- --- I54L --- --- I54M --- --- T74P --- --- L76V --- --- I84V --- --- L89V --- --- N88S --- --- M36I ---
Primary Outcomes
Measure: Proportion of subjects with Human immunodeficiency virus 1 (HIV-1) Ribonucleic Acid (RNA) < 50 c/mL Time: At Week 48Secondary Outcomes
Measure: Proportion of subjects with HIV-1 RNA < 50 c/mL Time: At week 24Measure: Change from baseline in CD4 cell count Time: Baseline (Week 0) and at week 48
Measure: Incidence rates of serious adverse event (SAEs) and adverse events (AEs) leading to discontinuation Time: up to week 48
Measure: Incidence rates of antiretroviral resistance measured by newly emergent genotypic substitutions and phenotypic resistance to study drugs for virologic failure Time: up to week 48
Measure: Proportion of subjects with HIV-1 RNA < 50 c/mL at Week 48 by baseline M184V presence or absence Time: Week 48