NCT00711009已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 206
- 试验地点
- 37
- 主要终点
- Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must provide written, voluntary informed consent to participate in the study.
- •Participants must be naive to antiretroviral treatment with HIV RNA greater than or equal to 1,000 copies/mL at screening, and in the investigator's opinion, require antiretroviral therapy.
- •Participant's vital signs, physical examination, and laboratory results must not exhibit evidence of acute illness.
- •Participant has not been treated for an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection within 45 days of initiating study drug. Participants who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with the Sponsor.
- •Participant does not require and agrees not to take any drugs that are contraindicated or have significant pharmacokinetic interactions with study drugs during the course of the study. Participant agrees not to take any medication during the study, including over-the-counter medicines, vitamins, minerals, herbal preparations, alcohol, or recreational drugs without the knowledge and permission of the principal investigator.
- •Female participants must be either postmenopausal for at least one year, surgically sterile, or must use a non-hormonal method of birth control that is acceptable to both the participant and investigator. All female participants must have a urine pregnancy test performed at screening visit and on Day minus 1/baseline, and results of both tests must be negative. Female participants may not be breastfeeding.
- •Participants have received no prior treatment with an HIV-1 integrase inhibitor.
排除标准
- •Participants must not have history of an allergic reaction or significant sensitivity to the study drugs.
- •Participants may not have an ongoing history of substance abuse or psychiatric illness that could preclude protocol adherence.
- •Participant cannot have resistance to lopinavir/ritonavir, tenofovir, or emtricitabine based on the HIV-1 drug resistance genotypic test results at the screening visit.
- •Participant may not have significant medical history of concomitant illness or disease that would adversely affect his/her participating in the study.
- •Participants may not have received any investigational drug or investigational vaccine within 30 days prior to study drug administration.
- •Participants may not have any of the following abnormal screening results: Hemoglobin <= 8.0 grams/deciliter, absolute neutrophil count <= 750 cells/microliter, Platelet count <= 50,000 per milliliter, alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) or aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) >= 3.0 x upper limit of normal (ULN), calculated creatinine clearance < 50 milliliter/minute, hepatitis B surface antigen (HBsAg) is positive.
- •The investigator considers the participant to be an unsuitable candidate for the study.
研究组 & 干预措施
LPV/r + FTC/TDF
Active Comparator
lopinavir/ritonavir 400/100 milligram (mg) tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
干预措施: lopinavir/ritonavir (LPV/r) (Drug)
LPV/r + FTC/TDF
Active Comparator
lopinavir/ritonavir 400/100 milligram (mg) tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily
干预措施: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (Drug)
LPV/r + RAL
Experimental
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
干预措施: lopinavir/ritonavir (LPV/r) (Drug)
LPV/r + RAL
Experimental
lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
干预措施: raltegravir (RAL) (Drug)
结局指标
主要结局
Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events
时间窗: Week 96
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.
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values
时间窗: Baseline to Week 96
Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.
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
时间窗: Baseline to Week 48
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.
次要结局
- Mean Change From Baseline in Temperature (°F)(Baseline to Week 96)
- Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)(Baseline to Week 96)
- Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit(Baseline to Week 96)
- Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672(Baseline to Week 96)
- Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey(Baseline to Week 96)
- Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)(Week 96)
- Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication(Week 96)
- Mean Change From Baseline in Hemoglobin (Grams/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Hematocrit (Fraction)(Baseline to Week 96)
- Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication(Week 96)
- Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)(Baseline to Week 96)
- Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Lipase (Units/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Magnesium (Millimoles/Liter)(Baseline to Week 96)
- 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(Baseline to Week 96)
- Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.(Baseline to Week 96)
- Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir(Baseline to Week 96)
- Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey(Baseline to Week 96)
- Mean Change From Baseline in Cholesterol (Micromoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)(Baseline to Week 96)
- Mean Change From Baseline in Triglycerides (Micromoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Platelet Count (x 10^9/Liter)(Baseline to Week 96)
- Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Neutrophils (x 10^9/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Uric Acid (Micromoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Lymphocytes (x 10^9/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Monocytes (x 10^9/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Eosinophils (x 10^9/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Basophils (x 10^9/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Creatinine (Micromoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Calcium (Micromoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Sodium (Micromoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Potassium (Micromoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Chloride (Micromoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Bicarbonate (Micromoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Albumin (Grams/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Total Protein (Grams/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)(Baseline to Week 96)
- Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Lactate (Millimoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)(Baseline to Week 96)
- Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)(Baseline to Week 96)
- Mean Change From Baseline in Leptin (Nanograms/Milliliter)(Baseline to Week 96)
- Mean Change From Baseline in Insulin (Picomoles/Liter)(Baseline to Week 96)
- Mean Change From Baseline in Urine Specific Gravity(Baseline to Week 96)
- Mean Change From Baseline in Urine pH(Baseline to Week 96)
- Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)(Baseline to Week 96)
- Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)(Baseline to Week 96)
- Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)(Baseline to Week 96)
- Mean Change From Baseline in Weight (kg)(Baseline to Week 96)
- Mean Change From Baseline in Chest Measurement (cm)(Baseline to Week 96)
- Mean Change From Baseline in Waist Measurement (cm)(Baseline to Week 96)
- Mean Change From Baseline in Mid-Arm Measurement (cm)(Baseline to Week 96)
- Mean Change From Baseline in Hips Measurement (cm)(Baseline to Week 96)
- Mean Change From Baseline in Mid-Thigh Measurement (cm)(Baseline to Week 96)
- Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)(Baseline to Week 96)
- Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)(Baseline to Week 96)
- Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)(Baseline to Week 96)
- Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)(Baseline to Week 96)
- Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)(Baseline to Week 96)
- Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)(Baseline to Week 96)
- Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)(Baseline to Week 96)
- Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)(Baseline to Week 96)
- Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)(Baseline to Week 96)
- Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)(Baseline to Week 96)
- Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)(Baseline to Week 96)
- Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)(Baseline to Week 96)
- Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)(Baseline to Week 96)
- Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)(Baseline to Week 96)
研究者
研究点 (37)
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